{"id":424842,"date":"2026-04-08T20:03:00","date_gmt":"2026-04-08T12:03:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=424842"},"modified":"2026-04-08T20:03:00","modified_gmt":"2026-04-08T12:03:00","slug":"supira-medical-%e5%ae%a3%e4%bd%88-support-ii-%e9%97%9c%e9%8d%b5%e6%80%a7%e8%a9%a6%e9%a9%97%e7%8d%b2-fda-%e6%89%b9%e5%87%86%ef%bc%8c%e4%b8%a6%e5%9c%a8%e5%bf%83%e6%ba%90%e6%80%a7%e4%bc%91%e5%85%8b","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=424842","title":{"rendered":"Supira Medical \u5ba3\u4f48 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u7372 FDA \u6279\u51c6\uff0c\u4e26\u5728\u5fc3\u6e90\u6027\u4f11\u514b\u9818\u57df\u53d6\u5f97\u9032\u5c55\uff0c\u540c\u6642\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703"},"content":{"rendered":"
\n\n\n\n
<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u591a\u9805\u91cc\u7a0b\u7891\u7a81\u986f\u81e8\u5e8a\u9032\u5c55\u4e26\u978f\u56fa\u5546\u696d\u57fa\u790e<\/i><\/p>\n

\u52a0\u5dde\u6d1b\u65af\u52a0\u6258\u65af<\/span>2026\u5e744\u67088\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — Supira Medical, Inc.<\/b><\/a> (Supira) \u662f\u4e00\u5bb6\u5c08\u6ce8\u65bc\u9769\u65b0\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u7684\u81e8\u5e8a\u968e\u6bb5\u516c\u53f8\uff0c\u4eca\u65e5\u5ba3\u4f48\u5df2\u7372\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\u555f\u52d5 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u3002\u8a72\u8a66\u9a57\u65e8\u5728\u70ba\u672a\u4f86\u63d0\u4ea4\u4e0a\u5e02\u524d\u6279\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u6a19\u8a8c\u8457\u516c\u53f8\u9081\u5411\u7f8e\u570b\u5e02\u5834\u7684\u91cd\u8981\u4e00\u6b65\u3002<\/p>\n

SUPPORT II (SU<\/u>pira System in\u00a0P<\/u>atients Undergoing High-Risk\u00a0P<\/u>ercutaneous CO<\/u>ronaR<\/u>y InT<\/u>ervention (HRPCI)) \u662f\u4e00\u9805\u524d\u77bb\u6027\u3001\u96a8\u6a5f\u5206\u914d\u5c0d\u7167\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30\u516c\u53f8\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5728\u63a5\u53d7\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u53ca\u7642\u6548\u3002\u8a72\u7814\u7a76\u5c07\u65bc\u7f8e\u570b\u6700\u591a 40 \u500b\u91ab\u7642\u4e2d\u5fc3\u62db\u52df\u6700\u591a 385 \u540d\u60a3\u8005\uff0c\u4e26\u7531\u5169\u4f4d\u5168\u7f8e\u806f\u5e2d\u9996\u5e2d\u7814\u7a76\u54e1\u9818\u5c0e\uff0c\u5305\u62ec\u54e5\u502b\u6bd4\u4e9e\u5927\u5b78\u74e6\u683c\u6d1b\u65af\u91ab\u5b78\u9662 (Vagelos College of Physicians and Surgeons) \u53ca\u7d10\u7d04\u9577\u8001\u6703\u91ab\u9662 (New York-Presbyterian Hospital) \u91ab\u5b78\u6559\u6388 Ajay Kirtane \u91ab\u751f\uff0c\u4ee5\u53ca\u4f4d\u65bc\u4f50\u6cbb\u4e9e\u5dde\u4e9e\u7279\u862d\u5927\u7684 Piedmont Heart Institute \u4e3b\u4efb\u517c Piedmont Healthcare \u9996\u5e2d\u79d1\u5b78\u7e3d\u76e3 David Kandzari \u91ab\u751f\u3002<\/p>\n

Kandzari \u91ab\u751f\u8868\u793a\uff1a\u300c\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u4e2d\uff0c\u662f\u5426\u63a1\u7528\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u901a\u8def\u53ef\u53ca\u6027\u3001\u5668\u68b0\u8f38\u9001\u6027\u80fd\uff0c\u4ee5\u53ca\u652f\u6301\u6548\u679c\u8207\u624b\u8853\u6548\u7387\u4e4b\u9593\u7684\u5e73\u8861\u3002\u4e00\u7a2e\u80fd\u4ee5\u66f4\u5c0f\u9ad4\u7a4d\u63d0\u4f9b\u6709\u6548\u5faa\u74b0\u652f\u6301\u7684\u7cfb\u7d71\uff0c\u6709\u6f5b\u529b\u64f4\u5927\u53ef\u63a5\u53d7\u6cbb\u7642\u7684\u60a3\u8005\u7fa4\u9ad4\uff0c\u4e26\u63d0\u5347\u7642\u6548\u3002\u300d<\/p>\n

Kirtane \u91ab\u751f\u8868\u793a\uff1a\u300c\u9069\u7576\u4f7f\u7528\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u53ef\u8b93\u91ab\u751f\u5728\u5b89\u5168\u60c5\u6cc1\u4e0b\u57f7\u884c\u6975\u5ea6\u8907\u96dc\u7684\u624b\u8853\uff0c\u70ba\u4ee5\u5f80\u6cbb\u7642\u9078\u64c7\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI)\u3002\u555f\u52d5\u9019\u9805\u91dd\u5c0d\u65b0\u578b\u3001\u4f4e\u5916\u5f91\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\u88dd\u7f6e\u7684\u95dc\u9375\u6027\u96a8\u6a5f\u8a66\u9a57\uff0c\u662f\u63a8\u52d5\u90e8\u5206\u6700\u9ad8\u98a8\u96aa\u60a3\u8005\u6cbb\u7642\u9032\u5c55\u7684\u91cd\u8981\u4e00\u6b65\u3002\u300d<\/p>\n

\u5fc3\u6e90\u6027\u4f11\u514b\u6cbb\u7642\u7684\u6700\u65b0\u9032\u5c55<\/b><\/p>\n

\u9664 SUPPORT II \u8a66\u9a57\u5916\uff0c\u516c\u53f8\u4ea6\u4e00\u76f4\u7a4d\u6975\u63a2\u7d22\u6a5f\u6703\uff0c\u4ee5\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6848\u3002\u8fd1\u671f\u65bc\u7f8e\u570b\u4ee5\u5916\u5730\u5340\u7684\u81e8\u5e8a\u75c5\u4f8b\u986f\u793a\uff0c\u9996\u6279\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u5df2\u63a1\u7528\u7d93\u76ae\u814b\u52d5\u8108\u5165\u8def\uff0c\u914d\u5408 10Fr \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u9032\u884c\u6cbb\u7642\uff0c\u4f7f\u60a3\u8005\u5728\u88dd\u7f6e\u904b\u4f5c\u671f\u9593\u80fd\u5920\u4e0b\u5e8a\u8d70\u52d5\u3002<\/p>\n

\u9019\u4e9b\u91cc\u7a0b\u7891\u5171\u540c\u7a81\u986f\u51fa\u65b0\u4e00\u4ee3\u81e8\u6642\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u6280\u8853\u6240\u5177\u5099\u7684\u6f5b\u5728\u80fd\u529b\uff0c\u5305\u62ec\u64f4\u5c55\u6cbb\u7642\u9078\u64c7\u3001\u652f\u6301\u60a3\u8005\u6d3b\u52d5\uff0c\u4ee5\u53ca\u63a8\u52d5\u91ab\u751f\u5728\u91cd\u75c7\u60a3\u8005\u7ba1\u7406\u65b9\u9762\u7684\u9032\u4e00\u6b65\u767c\u5c55\u3002<\/p>\n

\u5c0d\u65bc\u4ecb\u5165\u5fc3\u81df\u75c5\u5c08\u5bb6\u53ca\u5fc3\u81df\u8870\u7aed\u5c08\u79d1\u91ab\u751f\u800c\u8a00\uff0c\u5728\u7d93\u76ae\u4ecb\u5165\u5165\u8def\u5177\u5099\u9748\u6d3b\u6027\u7684\u540c\u6642\uff0c\u63d0\u4f9b\u5168\u9762\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u4e26\u8b93\u60a3\u8005\u5728\u6cbb\u7642\u671f\u9593\u4ecd\u53ef\u6d3b\u52d5\uff0c\u5747\u70ba\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u6574\u9ad4\u6cbb\u7642\u6d41\u7a0b\u7684\u91cd\u8981\u9032\u5c55\u3002<\/p>\n

\u59d4\u4efb\u91ab\u7642\u5668\u68b0\u696d\u8cc7\u6df1\u5c08\u5bb6 D. Keith Grossman \u70ba\u7368\u7acb\u8463\u4e8b<\/b><\/p>\n

\u5728\u4e0a\u8ff0\u81e8\u5e8a\u91cc\u7a0b\u7891\u63a8\u9032\u7684\u540c\u6642\uff0cSupira \u4ea6\u5ba3\u4f48\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703\u3002Grossman \u5148\u751f\u5728\u91ab\u7642\u79d1\u6280\u884c\u696d\u64c1\u6709 40 \u5e74\u9818\u5c0e\u7d93\u9a57\uff0c\u4e26\u66fe\u5728\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u9818\u57df\u767c\u63ee\u57fa\u672c\u4f5c\u7528\uff0c\u5c07\u6709\u52a9\u516c\u53f8\u52a0\u901f\u6e96\u5099\u9032\u5165\u5e02\u5834\u53ca\u63a8\u52d5\u696d\u52d9\u589e\u9577\u3002<\/p>\n

Supira Medical \u7e3d\u88c1\u517c\u884c\u653f\u7e3d\u88c1 Nitin Salunke \u535a\u58eb\u8868\u793a\uff1a\u300cKeith \u517c\u5177\u71df\u904b\u7d00\u5f8b\u3001\u5546\u696d\u6d1e\u5bdf\u529b\u53ca\u7b56\u7565\u8996\u91ce\uff0c\u70ba\u516c\u53f8\u5e36\u4f86\u6975\u5177\u50f9\u503c\u7684\u7d9c\u5408\u512a\u52e2\u3002\u4ed6\u4ee5\u7368\u7acb\u8463\u4e8b\u8eab\u4efd\u52a0\u5165\u8463\u4e8b\u6703\uff0c\u9ad4\u73fe\u6211\u5011\u81f4\u529b\u6253\u9020\u4e00\u500b\u4e0d\u50c5\u5728\u81e8\u5e8a\u5c64\u9762\u5177\u5099\u8207\u5225\u4e0d\u540c\u7684\u512a\u52e2\uff0c\u4ea6\u5177\u5099\u5927\u898f\u6a21\u57f7\u884c\u80fd\u529b\u7684\u7d44\u7e54\u3002\u300d<\/p>\n

Grossman \u5148\u751f\u8868\u793a\uff1a\u300cSupira \u5df2\u5efa\u7acb\u7a69\u56fa\u7684\u81e8\u5e8a\u53ca\u6280\u8853\u57fa\u790e\uff0c\u4e26\u5728\u6301\u7e8c\u589e\u9577\u4e14\u6ef2\u900f\u7387\u4ecd\u7136\u504f\u4f4e\u7684\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u4e2d\u5177\u5099\u7368\u7279\u512a\u52e2\uff0c\u6709\u671b\u63a8\u52d5\u884c\u696d\u8b8a\u9769\u3002\u6211\u671f\u5f85\u5728\u516c\u53f8\u63a8\u9032\u95dc\u9375\u6027\u81e8\u5e8a\u8a66\u9a57\u7684\u540c\u6642\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u5354\u52a9\u5176\u6210\u70ba\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u6cbb\u7642\u9818\u57df\u4e2d\u7684\u91cd\u8981\u9818\u5148\u529b\u91cf\u3002\u300d<\/p>\n

\u95dc\u65bc Supira Medical, Inc.<\/b><\/p>\n

Supira Medical \u81f4\u529b\u958b\u767c\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD)\uff0c\u7528\u65bc\u63a5\u53d7\u4ecb\u5165\u6027\u6cbb\u7642\u7684\u9ad8\u98a8\u96aa\u60a3\u8005\uff0c\u4ee5\u53ca\u51fa\u73fe\u5fc3\u6e90\u6027\u4f11\u514b\u7684\u60a3\u8005\u3002\u622a\u81f3\u76ee\u524d\uff0cSupira \u7cfb\u7d71\u5df2\u61c9\u7528\u65bc 99 \u540d\u60a3\u8005\u3002\u5982\u6b32\u4e86\u89e3\u66f4\u591a\u6709\u95dc Supira Medical \u7684\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.supiramedical.com<\/a>\u3002<\/p>\n

\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5c0d\u65bc\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u904e\u7a0b\u4e2d\u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u4e2d\u7dad\u6301\u5fc3\u8840\u7ba1\u529f\u80fd\u5177\u6709\u91cd\u8981\u4f5c\u7528\u3002\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u901a\u5e38\u5177\u6709\u8907\u96dc\u7684\u51a0\u72c0\u52d5\u8108\u89e3\u5256\u7d50\u69cb\u3001\u8840\u6d41\u52d5\u529b\u5b78\u4e0d\u7a69\u5b9a\u53ca\u591a\u91cd\u5171\u75c5\uff1b\u800c\u5fc3\u6e90\u6027\u4f11\u514b\u5247\u662f\u4e00\u7a2e\u9ad8\u6b7b\u4ea1\u7387\u7684\u75c5\u75c7\uff0c\u60a3\u8005\u5fc3\u81df\u640f\u52d5\u7121\u529b\uff0c\u7121\u6cd5\u6709\u6548\u5c07\u8db3\u5920\u7684\u8840\u6db2\u8f38\u9001\u81f3\u91cd\u8981\u5668\u5b98\uff0c\u901a\u5e38\u7531\u5fc3\u808c\u6897\u585e\u6216\u5fc3\u81df\u8870\u7aed\u6240\u5f15\u8d77\u3002<\/p>\n

Supira \u7cfb\u7d71\u70ba\u7814\u7a76\u6027\u91ab\u7642\u5668\u68b0\uff0c\u5c1a\u672a\u7372\u6279\u51c6\u5728\u7f8e\u570b\u6216\u5168\u7403\u4efb\u4f55\u5730\u5340\u92b7\u552e\u3002\u6839\u64da\u7f8e\u570b\u806f\u90a6\u6cd5\u5f8b\u898f\u5b9a\uff0c\u8a72\u5668\u68b0\u50c5\u9650\u7528\u65bc\u7814\u7a76\u7528\u9014\u3002<\/p>\n

\u5a92\u9ad4\u806f\u7d61\u4eba\uff1a
<\/b>Craig Brandli
\u5e02\u5834\u63a8\u5ee3\u526f\u7e3d\u88c1
craig@supiramedical.com<\/a><\/p>\n

\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u591a\u9805\u91cc\u7a0b\u7891\u7a81\u986f\u81e8\u5e8a\u9032\u5c55\u4e26\u978f\u56fa\u5546…<\/p>\n","protected":false},"author":16,"featured_media":424843,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[40567],"tags":[],"class_list":["post-424842","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"\nSupira Medical \u5ba3\u4f48 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u7372 FDA \u6279\u51c6\uff0c\u4e26\u5728\u5fc3\u6e90\u6027\u4f11\u514b\u9818\u57df\u53d6\u5f97\u9032\u5c55\uff0c\u540c\u6642\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831<\/title>\n<meta name=\"description\" content=\"\u591a\u9805\u91cc\u7a0b\u7891\u7a81\u986f\u81e8\u5e8a\u9032\u5c55\u4e26\u978f\u56fa\u5546\u696d\u57fa\u790e \u52a0\u5dde\u6d1b\u65af\u52a0\u6258\u65af2026\u5e744\u67088\u65e5 \/\u7f8e\u901a\u793e\/ -- Supira Medical, Inc. (Supira) \u662f\u4e00\u5bb6\u5c08\u6ce8\u65bc\u9769\u65b0\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u7684\u81e8\u5e8a\u968e\u6bb5\u516c\u53f8\uff0c\u4eca\u65e5\u5ba3\u4f48\u5df2\u7372\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\u555f\u52d5 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u3002\u8a72\u8a66\u9a57\u65e8\u5728\u70ba\u672a\u4f86\u63d0\u4ea4\u4e0a\u5e02\u524d\u6279\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u6a19\u8a8c\u8457\u516c\u53f8\u9081\u5411\u7f8e\u570b\u5e02\u5834\u7684\u91cd\u8981\u4e00\u6b65\u3002 SUPPORT II (SUpira System in\u00a0Patients Undergoing High-Risk\u00a0Percutaneous COronaRy InTervention (HRPCI)) \u662f\u4e00\u9805\u524d\u77bb\u6027\u3001\u96a8\u6a5f\u5206\u914d\u5c0d\u7167\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30\u516c\u53f8\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5728\u63a5\u53d7\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u53ca\u7642\u6548\u3002\u8a72\u7814\u7a76\u5c07\u65bc\u7f8e\u570b\u6700\u591a 40 \u500b\u91ab\u7642\u4e2d\u5fc3\u62db\u52df\u6700\u591a 385 \u540d\u60a3\u8005\uff0c\u4e26\u7531\u5169\u4f4d\u5168\u7f8e\u806f\u5e2d\u9996\u5e2d\u7814\u7a76\u54e1\u9818\u5c0e\uff0c\u5305\u62ec\u54e5\u502b\u6bd4\u4e9e\u5927\u5b78\u74e6\u683c\u6d1b\u65af\u91ab\u5b78\u9662 (Vagelos College of Physicians and Surgeons) \u53ca\u7d10\u7d04\u9577\u8001\u6703\u91ab\u9662 (New York-Presbyterian Hospital) \u91ab\u5b78\u6559\u6388 Ajay Kirtane \u91ab\u751f\uff0c\u4ee5\u53ca\u4f4d\u65bc\u4f50\u6cbb\u4e9e\u5dde\u4e9e\u7279\u862d\u5927\u7684 Piedmont Heart Institute \u4e3b\u4efb\u517c Piedmont Healthcare \u9996\u5e2d\u79d1\u5b78\u7e3d\u76e3 David Kandzari \u91ab\u751f\u3002 Kandzari \u91ab\u751f\u8868\u793a\uff1a\u300c\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u4e2d\uff0c\u662f\u5426\u63a1\u7528\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u901a\u8def\u53ef\u53ca\u6027\u3001\u5668\u68b0\u8f38\u9001\u6027\u80fd\uff0c\u4ee5\u53ca\u652f\u6301\u6548\u679c\u8207\u624b\u8853\u6548\u7387\u4e4b\u9593\u7684\u5e73\u8861\u3002\u4e00\u7a2e\u80fd\u4ee5\u66f4\u5c0f\u9ad4\u7a4d\u63d0\u4f9b\u6709\u6548\u5faa\u74b0\u652f\u6301\u7684\u7cfb\u7d71\uff0c\u6709\u6f5b\u529b\u64f4\u5927\u53ef\u63a5\u53d7\u6cbb\u7642\u7684\u60a3\u8005\u7fa4\u9ad4\uff0c\u4e26\u63d0\u5347\u7642\u6548\u3002\u300d Kirtane \u91ab\u751f\u8868\u793a\uff1a\u300c\u9069\u7576\u4f7f\u7528\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u53ef\u8b93\u91ab\u751f\u5728\u5b89\u5168\u60c5\u6cc1\u4e0b\u57f7\u884c\u6975\u5ea6\u8907\u96dc\u7684\u624b\u8853\uff0c\u70ba\u4ee5\u5f80\u6cbb\u7642\u9078\u64c7\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI)\u3002\u555f\u52d5\u9019\u9805\u91dd\u5c0d\u65b0\u578b\u3001\u4f4e\u5916\u5f91\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\u88dd\u7f6e\u7684\u95dc\u9375\u6027\u96a8\u6a5f\u8a66\u9a57\uff0c\u662f\u63a8\u52d5\u90e8\u5206\u6700\u9ad8\u98a8\u96aa\u60a3\u8005\u6cbb\u7642\u9032\u5c55\u7684\u91cd\u8981\u4e00\u6b65\u3002\u300d \u5fc3\u6e90\u6027\u4f11\u514b\u6cbb\u7642\u7684\u6700\u65b0\u9032\u5c55 \u9664 SUPPORT II \u8a66\u9a57\u5916\uff0c\u516c\u53f8\u4ea6\u4e00\u76f4\u7a4d\u6975\u63a2\u7d22\u6a5f\u6703\uff0c\u4ee5\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6848\u3002\u8fd1\u671f\u65bc\u7f8e\u570b\u4ee5\u5916\u5730\u5340\u7684\u81e8\u5e8a\u75c5\u4f8b\u986f\u793a\uff0c\u9996\u6279\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u5df2\u63a1\u7528\u7d93\u76ae\u814b\u52d5\u8108\u5165\u8def\uff0c\u914d\u5408 10Fr \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u9032\u884c\u6cbb\u7642\uff0c\u4f7f\u60a3\u8005\u5728\u88dd\u7f6e\u904b\u4f5c\u671f\u9593\u80fd\u5920\u4e0b\u5e8a\u8d70\u52d5\u3002 \u9019\u4e9b\u91cc\u7a0b\u7891\u5171\u540c\u7a81\u986f\u51fa\u65b0\u4e00\u4ee3\u81e8\u6642\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u6280\u8853\u6240\u5177\u5099\u7684\u6f5b\u5728\u80fd\u529b\uff0c\u5305\u62ec\u64f4\u5c55\u6cbb\u7642\u9078\u64c7\u3001\u652f\u6301\u60a3\u8005\u6d3b\u52d5\uff0c\u4ee5\u53ca\u63a8\u52d5\u91ab\u751f\u5728\u91cd\u75c7\u60a3\u8005\u7ba1\u7406\u65b9\u9762\u7684\u9032\u4e00\u6b65\u767c\u5c55\u3002 \u5c0d\u65bc\u4ecb\u5165\u5fc3\u81df\u75c5\u5c08\u5bb6\u53ca\u5fc3\u81df\u8870\u7aed\u5c08\u79d1\u91ab\u751f\u800c\u8a00\uff0c\u5728\u7d93\u76ae\u4ecb\u5165\u5165\u8def\u5177\u5099\u9748\u6d3b\u6027\u7684\u540c\u6642\uff0c\u63d0\u4f9b\u5168\u9762\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u4e26\u8b93\u60a3\u8005\u5728\u6cbb\u7642\u671f\u9593\u4ecd\u53ef\u6d3b\u52d5\uff0c\u5747\u70ba\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u6574\u9ad4\u6cbb\u7642\u6d41\u7a0b\u7684\u91cd\u8981\u9032\u5c55\u3002 \u59d4\u4efb\u91ab\u7642\u5668\u68b0\u696d\u8cc7\u6df1\u5c08\u5bb6 D. Keith Grossman \u70ba\u7368\u7acb\u8463\u4e8b \u5728\u4e0a\u8ff0\u81e8\u5e8a\u91cc\u7a0b\u7891\u63a8\u9032\u7684\u540c\u6642\uff0cSupira \u4ea6\u5ba3\u4f48\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703\u3002Grossman \u5148\u751f\u5728\u91ab\u7642\u79d1\u6280\u884c\u696d\u64c1\u6709 40 \u5e74\u9818\u5c0e\u7d93\u9a57\uff0c\u4e26\u66fe\u5728\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u9818\u57df\u767c\u63ee\u57fa\u672c\u4f5c\u7528\uff0c\u5c07\u6709\u52a9\u516c\u53f8\u52a0\u901f\u6e96\u5099\u9032\u5165\u5e02\u5834\u53ca\u63a8\u52d5\u696d\u52d9\u589e\u9577\u3002 Supira Medical \u7e3d\u88c1\u517c\u884c\u653f\u7e3d\u88c1 Nitin Salunke \u535a\u58eb\u8868\u793a\uff1a\u300cKeith \u517c\u5177\u71df\u904b\u7d00\u5f8b\u3001\u5546\u696d\u6d1e\u5bdf\u529b\u53ca\u7b56\u7565\u8996\u91ce\uff0c\u70ba\u516c\u53f8\u5e36\u4f86\u6975\u5177\u50f9\u503c\u7684\u7d9c\u5408\u512a\u52e2\u3002\u4ed6\u4ee5\u7368\u7acb\u8463\u4e8b\u8eab\u4efd\u52a0\u5165\u8463\u4e8b\u6703\uff0c\u9ad4\u73fe\u6211\u5011\u81f4\u529b\u6253\u9020\u4e00\u500b\u4e0d\u50c5\u5728\u81e8\u5e8a\u5c64\u9762\u5177\u5099\u8207\u5225\u4e0d\u540c\u7684\u512a\u52e2\uff0c\u4ea6\u5177\u5099\u5927\u898f\u6a21\u57f7\u884c\u80fd\u529b\u7684\u7d44\u7e54\u3002\u300d Grossman \u5148\u751f\u8868\u793a\uff1a\u300cSupira \u5df2\u5efa\u7acb\u7a69\u56fa\u7684\u81e8\u5e8a\u53ca\u6280\u8853\u57fa\u790e\uff0c\u4e26\u5728\u6301\u7e8c\u589e\u9577\u4e14\u6ef2\u900f\u7387\u4ecd\u7136\u504f\u4f4e\u7684\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u4e2d\u5177\u5099\u7368\u7279\u512a\u52e2\uff0c\u6709\u671b\u63a8\u52d5\u884c\u696d\u8b8a\u9769\u3002\u6211\u671f\u5f85\u5728\u516c\u53f8\u63a8\u9032\u95dc\u9375\u6027\u81e8\u5e8a\u8a66\u9a57\u7684\u540c\u6642\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u5354\u52a9\u5176\u6210\u70ba\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u6cbb\u7642\u9818\u57df\u4e2d\u7684\u91cd\u8981\u9818\u5148\u529b\u91cf\u3002\u300d \u95dc\u65bc Supira Medical, Inc. Supira Medical \u81f4\u529b\u958b\u767c\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD)\uff0c\u7528\u65bc\u63a5\u53d7\u4ecb\u5165\u6027\u6cbb\u7642\u7684\u9ad8\u98a8\u96aa\u60a3\u8005\uff0c\u4ee5\u53ca\u51fa\u73fe\u5fc3\u6e90\u6027\u4f11\u514b\u7684\u60a3\u8005\u3002\u622a\u81f3\u76ee\u524d\uff0cSupira \u7cfb\u7d71\u5df2\u61c9\u7528\u65bc 99 \u540d\u60a3\u8005\u3002\u5982\u6b32\u4e86\u89e3\u66f4\u591a\u6709\u95dc Supira Medical \u7684\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.supiramedical.com\u3002 \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5c0d\u65bc\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u904e\u7a0b\u4e2d\u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u4e2d\u7dad\u6301\u5fc3\u8840\u7ba1\u529f\u80fd\u5177\u6709\u91cd\u8981\u4f5c\u7528\u3002\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u901a\u5e38\u5177\u6709\u8907\u96dc\u7684\u51a0\u72c0\u52d5\u8108\u89e3\u5256\u7d50\u69cb\u3001\u8840\u6d41\u52d5\u529b\u5b78\u4e0d\u7a69\u5b9a\u53ca\u591a\u91cd\u5171\u75c5\uff1b\u800c\u5fc3\u6e90\u6027\u4f11\u514b\u5247\u662f\u4e00\u7a2e\u9ad8\u6b7b\u4ea1\u7387\u7684\u75c5\u75c7\uff0c\u60a3\u8005\u5fc3\u81df\u640f\u52d5\u7121\u529b\uff0c\u7121\u6cd5\u6709\u6548\u5c07\u8db3\u5920\u7684\u8840\u6db2\u8f38\u9001\u81f3\u91cd\u8981\u5668\u5b98\uff0c\u901a\u5e38\u7531\u5fc3\u808c\u6897\u585e\u6216\u5fc3\u81df\u8870\u7aed\u6240\u5f15\u8d77\u3002 Supira \u7cfb\u7d71\u70ba\u7814\u7a76\u6027\u91ab\u7642\u5668\u68b0\uff0c\u5c1a\u672a\u7372\u6279\u51c6\u5728\u7f8e\u570b\u6216\u5168\u7403\u4efb\u4f55\u5730\u5340\u92b7\u552e\u3002\u6839\u64da\u7f8e\u570b\u806f\u90a6\u6cd5\u5f8b\u898f\u5b9a\uff0c\u8a72\u5668\u68b0\u50c5\u9650\u7528\u65bc\u7814\u7a76\u7528\u9014\u3002 \u5a92\u9ad4\u806f\u7d61\u4eba\uff1aCraig Brandli\u5e02\u5834\u63a8\u5ee3\u526f\u7e3d\u88c1craig@supiramedical.com \u00a0\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pingtungtimes.com.tw\/?p=424842\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Supira Medical \u5ba3\u4f48 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u7372 FDA \u6279\u51c6\uff0c\u4e26\u5728\u5fc3\u6e90\u6027\u4f11\u514b\u9818\u57df\u53d6\u5f97\u9032\u5c55\uff0c\u540c\u6642\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u591a\u9805\u91cc\u7a0b\u7891\u7a81\u986f\u81e8\u5e8a\u9032\u5c55\u4e26\u978f\u56fa\u5546\u696d\u57fa\u790e \u52a0\u5dde\u6d1b\u65af\u52a0\u6258\u65af2026\u5e744\u67088\u65e5 \/\u7f8e\u901a\u793e\/ -- Supira Medical, Inc. (Supira) \u662f\u4e00\u5bb6\u5c08\u6ce8\u65bc\u9769\u65b0\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u7684\u81e8\u5e8a\u968e\u6bb5\u516c\u53f8\uff0c\u4eca\u65e5\u5ba3\u4f48\u5df2\u7372\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\u555f\u52d5 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u3002\u8a72\u8a66\u9a57\u65e8\u5728\u70ba\u672a\u4f86\u63d0\u4ea4\u4e0a\u5e02\u524d\u6279\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u6a19\u8a8c\u8457\u516c\u53f8\u9081\u5411\u7f8e\u570b\u5e02\u5834\u7684\u91cd\u8981\u4e00\u6b65\u3002 SUPPORT II (SUpira System in\u00a0Patients Undergoing High-Risk\u00a0Percutaneous COronaRy InTervention (HRPCI)) \u662f\u4e00\u9805\u524d\u77bb\u6027\u3001\u96a8\u6a5f\u5206\u914d\u5c0d\u7167\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30\u516c\u53f8\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5728\u63a5\u53d7\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u53ca\u7642\u6548\u3002\u8a72\u7814\u7a76\u5c07\u65bc\u7f8e\u570b\u6700\u591a 40 \u500b\u91ab\u7642\u4e2d\u5fc3\u62db\u52df\u6700\u591a 385 \u540d\u60a3\u8005\uff0c\u4e26\u7531\u5169\u4f4d\u5168\u7f8e\u806f\u5e2d\u9996\u5e2d\u7814\u7a76\u54e1\u9818\u5c0e\uff0c\u5305\u62ec\u54e5\u502b\u6bd4\u4e9e\u5927\u5b78\u74e6\u683c\u6d1b\u65af\u91ab\u5b78\u9662 (Vagelos College of Physicians and Surgeons) \u53ca\u7d10\u7d04\u9577\u8001\u6703\u91ab\u9662 (New York-Presbyterian Hospital) \u91ab\u5b78\u6559\u6388 Ajay Kirtane \u91ab\u751f\uff0c\u4ee5\u53ca\u4f4d\u65bc\u4f50\u6cbb\u4e9e\u5dde\u4e9e\u7279\u862d\u5927\u7684 Piedmont Heart Institute \u4e3b\u4efb\u517c Piedmont Healthcare \u9996\u5e2d\u79d1\u5b78\u7e3d\u76e3 David Kandzari \u91ab\u751f\u3002 Kandzari \u91ab\u751f\u8868\u793a\uff1a\u300c\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u4e2d\uff0c\u662f\u5426\u63a1\u7528\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u901a\u8def\u53ef\u53ca\u6027\u3001\u5668\u68b0\u8f38\u9001\u6027\u80fd\uff0c\u4ee5\u53ca\u652f\u6301\u6548\u679c\u8207\u624b\u8853\u6548\u7387\u4e4b\u9593\u7684\u5e73\u8861\u3002\u4e00\u7a2e\u80fd\u4ee5\u66f4\u5c0f\u9ad4\u7a4d\u63d0\u4f9b\u6709\u6548\u5faa\u74b0\u652f\u6301\u7684\u7cfb\u7d71\uff0c\u6709\u6f5b\u529b\u64f4\u5927\u53ef\u63a5\u53d7\u6cbb\u7642\u7684\u60a3\u8005\u7fa4\u9ad4\uff0c\u4e26\u63d0\u5347\u7642\u6548\u3002\u300d Kirtane \u91ab\u751f\u8868\u793a\uff1a\u300c\u9069\u7576\u4f7f\u7528\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u53ef\u8b93\u91ab\u751f\u5728\u5b89\u5168\u60c5\u6cc1\u4e0b\u57f7\u884c\u6975\u5ea6\u8907\u96dc\u7684\u624b\u8853\uff0c\u70ba\u4ee5\u5f80\u6cbb\u7642\u9078\u64c7\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI)\u3002\u555f\u52d5\u9019\u9805\u91dd\u5c0d\u65b0\u578b\u3001\u4f4e\u5916\u5f91\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\u88dd\u7f6e\u7684\u95dc\u9375\u6027\u96a8\u6a5f\u8a66\u9a57\uff0c\u662f\u63a8\u52d5\u90e8\u5206\u6700\u9ad8\u98a8\u96aa\u60a3\u8005\u6cbb\u7642\u9032\u5c55\u7684\u91cd\u8981\u4e00\u6b65\u3002\u300d \u5fc3\u6e90\u6027\u4f11\u514b\u6cbb\u7642\u7684\u6700\u65b0\u9032\u5c55 \u9664 SUPPORT II \u8a66\u9a57\u5916\uff0c\u516c\u53f8\u4ea6\u4e00\u76f4\u7a4d\u6975\u63a2\u7d22\u6a5f\u6703\uff0c\u4ee5\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6848\u3002\u8fd1\u671f\u65bc\u7f8e\u570b\u4ee5\u5916\u5730\u5340\u7684\u81e8\u5e8a\u75c5\u4f8b\u986f\u793a\uff0c\u9996\u6279\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u5df2\u63a1\u7528\u7d93\u76ae\u814b\u52d5\u8108\u5165\u8def\uff0c\u914d\u5408 10Fr \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u9032\u884c\u6cbb\u7642\uff0c\u4f7f\u60a3\u8005\u5728\u88dd\u7f6e\u904b\u4f5c\u671f\u9593\u80fd\u5920\u4e0b\u5e8a\u8d70\u52d5\u3002 \u9019\u4e9b\u91cc\u7a0b\u7891\u5171\u540c\u7a81\u986f\u51fa\u65b0\u4e00\u4ee3\u81e8\u6642\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u6280\u8853\u6240\u5177\u5099\u7684\u6f5b\u5728\u80fd\u529b\uff0c\u5305\u62ec\u64f4\u5c55\u6cbb\u7642\u9078\u64c7\u3001\u652f\u6301\u60a3\u8005\u6d3b\u52d5\uff0c\u4ee5\u53ca\u63a8\u52d5\u91ab\u751f\u5728\u91cd\u75c7\u60a3\u8005\u7ba1\u7406\u65b9\u9762\u7684\u9032\u4e00\u6b65\u767c\u5c55\u3002 \u5c0d\u65bc\u4ecb\u5165\u5fc3\u81df\u75c5\u5c08\u5bb6\u53ca\u5fc3\u81df\u8870\u7aed\u5c08\u79d1\u91ab\u751f\u800c\u8a00\uff0c\u5728\u7d93\u76ae\u4ecb\u5165\u5165\u8def\u5177\u5099\u9748\u6d3b\u6027\u7684\u540c\u6642\uff0c\u63d0\u4f9b\u5168\u9762\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u4e26\u8b93\u60a3\u8005\u5728\u6cbb\u7642\u671f\u9593\u4ecd\u53ef\u6d3b\u52d5\uff0c\u5747\u70ba\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u6574\u9ad4\u6cbb\u7642\u6d41\u7a0b\u7684\u91cd\u8981\u9032\u5c55\u3002 \u59d4\u4efb\u91ab\u7642\u5668\u68b0\u696d\u8cc7\u6df1\u5c08\u5bb6 D. Keith Grossman \u70ba\u7368\u7acb\u8463\u4e8b \u5728\u4e0a\u8ff0\u81e8\u5e8a\u91cc\u7a0b\u7891\u63a8\u9032\u7684\u540c\u6642\uff0cSupira \u4ea6\u5ba3\u4f48\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703\u3002Grossman \u5148\u751f\u5728\u91ab\u7642\u79d1\u6280\u884c\u696d\u64c1\u6709 40 \u5e74\u9818\u5c0e\u7d93\u9a57\uff0c\u4e26\u66fe\u5728\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u9818\u57df\u767c\u63ee\u57fa\u672c\u4f5c\u7528\uff0c\u5c07\u6709\u52a9\u516c\u53f8\u52a0\u901f\u6e96\u5099\u9032\u5165\u5e02\u5834\u53ca\u63a8\u52d5\u696d\u52d9\u589e\u9577\u3002 Supira Medical \u7e3d\u88c1\u517c\u884c\u653f\u7e3d\u88c1 Nitin Salunke \u535a\u58eb\u8868\u793a\uff1a\u300cKeith \u517c\u5177\u71df\u904b\u7d00\u5f8b\u3001\u5546\u696d\u6d1e\u5bdf\u529b\u53ca\u7b56\u7565\u8996\u91ce\uff0c\u70ba\u516c\u53f8\u5e36\u4f86\u6975\u5177\u50f9\u503c\u7684\u7d9c\u5408\u512a\u52e2\u3002\u4ed6\u4ee5\u7368\u7acb\u8463\u4e8b\u8eab\u4efd\u52a0\u5165\u8463\u4e8b\u6703\uff0c\u9ad4\u73fe\u6211\u5011\u81f4\u529b\u6253\u9020\u4e00\u500b\u4e0d\u50c5\u5728\u81e8\u5e8a\u5c64\u9762\u5177\u5099\u8207\u5225\u4e0d\u540c\u7684\u512a\u52e2\uff0c\u4ea6\u5177\u5099\u5927\u898f\u6a21\u57f7\u884c\u80fd\u529b\u7684\u7d44\u7e54\u3002\u300d Grossman \u5148\u751f\u8868\u793a\uff1a\u300cSupira \u5df2\u5efa\u7acb\u7a69\u56fa\u7684\u81e8\u5e8a\u53ca\u6280\u8853\u57fa\u790e\uff0c\u4e26\u5728\u6301\u7e8c\u589e\u9577\u4e14\u6ef2\u900f\u7387\u4ecd\u7136\u504f\u4f4e\u7684\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u4e2d\u5177\u5099\u7368\u7279\u512a\u52e2\uff0c\u6709\u671b\u63a8\u52d5\u884c\u696d\u8b8a\u9769\u3002\u6211\u671f\u5f85\u5728\u516c\u53f8\u63a8\u9032\u95dc\u9375\u6027\u81e8\u5e8a\u8a66\u9a57\u7684\u540c\u6642\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u5354\u52a9\u5176\u6210\u70ba\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u6cbb\u7642\u9818\u57df\u4e2d\u7684\u91cd\u8981\u9818\u5148\u529b\u91cf\u3002\u300d \u95dc\u65bc Supira Medical, Inc. Supira Medical \u81f4\u529b\u958b\u767c\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD)\uff0c\u7528\u65bc\u63a5\u53d7\u4ecb\u5165\u6027\u6cbb\u7642\u7684\u9ad8\u98a8\u96aa\u60a3\u8005\uff0c\u4ee5\u53ca\u51fa\u73fe\u5fc3\u6e90\u6027\u4f11\u514b\u7684\u60a3\u8005\u3002\u622a\u81f3\u76ee\u524d\uff0cSupira \u7cfb\u7d71\u5df2\u61c9\u7528\u65bc 99 \u540d\u60a3\u8005\u3002\u5982\u6b32\u4e86\u89e3\u66f4\u591a\u6709\u95dc Supira Medical \u7684\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.supiramedical.com\u3002 \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5c0d\u65bc\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u904e\u7a0b\u4e2d\u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u4e2d\u7dad\u6301\u5fc3\u8840\u7ba1\u529f\u80fd\u5177\u6709\u91cd\u8981\u4f5c\u7528\u3002\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u901a\u5e38\u5177\u6709\u8907\u96dc\u7684\u51a0\u72c0\u52d5\u8108\u89e3\u5256\u7d50\u69cb\u3001\u8840\u6d41\u52d5\u529b\u5b78\u4e0d\u7a69\u5b9a\u53ca\u591a\u91cd\u5171\u75c5\uff1b\u800c\u5fc3\u6e90\u6027\u4f11\u514b\u5247\u662f\u4e00\u7a2e\u9ad8\u6b7b\u4ea1\u7387\u7684\u75c5\u75c7\uff0c\u60a3\u8005\u5fc3\u81df\u640f\u52d5\u7121\u529b\uff0c\u7121\u6cd5\u6709\u6548\u5c07\u8db3\u5920\u7684\u8840\u6db2\u8f38\u9001\u81f3\u91cd\u8981\u5668\u5b98\uff0c\u901a\u5e38\u7531\u5fc3\u808c\u6897\u585e\u6216\u5fc3\u81df\u8870\u7aed\u6240\u5f15\u8d77\u3002 Supira \u7cfb\u7d71\u70ba\u7814\u7a76\u6027\u91ab\u7642\u5668\u68b0\uff0c\u5c1a\u672a\u7372\u6279\u51c6\u5728\u7f8e\u570b\u6216\u5168\u7403\u4efb\u4f55\u5730\u5340\u92b7\u552e\u3002\u6839\u64da\u7f8e\u570b\u806f\u90a6\u6cd5\u5f8b\u898f\u5b9a\uff0c\u8a72\u5668\u68b0\u50c5\u9650\u7528\u65bc\u7814\u7a76\u7528\u9014\u3002 \u5a92\u9ad4\u806f\u7d61\u4eba\uff1aCraig Brandli\u5e02\u5834\u63a8\u5ee3\u526f\u7e3d\u88c1craig@supiramedical.com \u00a0\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pingtungtimes.com.tw\/?p=424842\" \/>\n<meta property=\"og:site_name\" content=\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/pingtungnews\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-08T12:03:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png\" \/>\n\t<meta property=\"og:image:width\" content=\"3000\" \/>\n\t<meta property=\"og:image:height\" content=\"1990\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"\u7f8e\u901a\u793e\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005:\" \/>\n\t<meta name=\"twitter:data1\" content=\"\u7f8e\u901a\u793e\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"NewsArticle\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=424842#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=424842\"},\"author\":{\"name\":\"\u7f8e\u901a\u793e\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\"},\"headline\":\"Supira Medical \u5ba3\u4f48 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u7372 FDA \u6279\u51c6\uff0c\u4e26\u5728\u5fc3\u6e90\u6027\u4f11\u514b\u9818\u57df\u53d6\u5f97\u9032\u5c55\uff0c\u540c\u6642\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703\",\"datePublished\":\"2026-04-08T12:03:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=424842\"},\"wordCount\":97,\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=424842#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/SupiraMedical_Logo_Logo_Logo.jpg\",\"articleSection\":[\"\u7f8e\u901a\u793e\"],\"inLanguage\":\"zh-TW\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=424842\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=424842\",\"name\":\"Supira Medical \u5ba3\u4f48 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u7372 FDA \u6279\u51c6\uff0c\u4e26\u5728\u5fc3\u6e90\u6027\u4f11\u514b\u9818\u57df\u53d6\u5f97\u9032\u5c55\uff0c\u540c\u6642\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=424842#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=424842#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/SupiraMedical_Logo_Logo_Logo.jpg\",\"datePublished\":\"2026-04-08T12:03:00+00:00\",\"description\":\"\u591a\u9805\u91cc\u7a0b\u7891\u7a81\u986f\u81e8\u5e8a\u9032\u5c55\u4e26\u978f\u56fa\u5546\u696d\u57fa\u790e \u52a0\u5dde\u6d1b\u65af\u52a0\u6258\u65af2026\u5e744\u67088\u65e5 \\\/\u7f8e\u901a\u793e\\\/ -- Supira Medical, Inc. (Supira) \u662f\u4e00\u5bb6\u5c08\u6ce8\u65bc\u9769\u65b0\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u7684\u81e8\u5e8a\u968e\u6bb5\u516c\u53f8\uff0c\u4eca\u65e5\u5ba3\u4f48\u5df2\u7372\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\u555f\u52d5 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u3002\u8a72\u8a66\u9a57\u65e8\u5728\u70ba\u672a\u4f86\u63d0\u4ea4\u4e0a\u5e02\u524d\u6279\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u6a19\u8a8c\u8457\u516c\u53f8\u9081\u5411\u7f8e\u570b\u5e02\u5834\u7684\u91cd\u8981\u4e00\u6b65\u3002 SUPPORT II (SUpira System in\u00a0Patients Undergoing High-Risk\u00a0Percutaneous COronaRy InTervention (HRPCI)) \u662f\u4e00\u9805\u524d\u77bb\u6027\u3001\u96a8\u6a5f\u5206\u914d\u5c0d\u7167\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30\u516c\u53f8\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5728\u63a5\u53d7\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u53ca\u7642\u6548\u3002\u8a72\u7814\u7a76\u5c07\u65bc\u7f8e\u570b\u6700\u591a 40 \u500b\u91ab\u7642\u4e2d\u5fc3\u62db\u52df\u6700\u591a 385 \u540d\u60a3\u8005\uff0c\u4e26\u7531\u5169\u4f4d\u5168\u7f8e\u806f\u5e2d\u9996\u5e2d\u7814\u7a76\u54e1\u9818\u5c0e\uff0c\u5305\u62ec\u54e5\u502b\u6bd4\u4e9e\u5927\u5b78\u74e6\u683c\u6d1b\u65af\u91ab\u5b78\u9662 (Vagelos College of Physicians and Surgeons) \u53ca\u7d10\u7d04\u9577\u8001\u6703\u91ab\u9662 (New York-Presbyterian Hospital) \u91ab\u5b78\u6559\u6388 Ajay Kirtane \u91ab\u751f\uff0c\u4ee5\u53ca\u4f4d\u65bc\u4f50\u6cbb\u4e9e\u5dde\u4e9e\u7279\u862d\u5927\u7684 Piedmont Heart Institute \u4e3b\u4efb\u517c Piedmont Healthcare \u9996\u5e2d\u79d1\u5b78\u7e3d\u76e3 David Kandzari \u91ab\u751f\u3002 Kandzari \u91ab\u751f\u8868\u793a\uff1a\u300c\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u4e2d\uff0c\u662f\u5426\u63a1\u7528\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u901a\u8def\u53ef\u53ca\u6027\u3001\u5668\u68b0\u8f38\u9001\u6027\u80fd\uff0c\u4ee5\u53ca\u652f\u6301\u6548\u679c\u8207\u624b\u8853\u6548\u7387\u4e4b\u9593\u7684\u5e73\u8861\u3002\u4e00\u7a2e\u80fd\u4ee5\u66f4\u5c0f\u9ad4\u7a4d\u63d0\u4f9b\u6709\u6548\u5faa\u74b0\u652f\u6301\u7684\u7cfb\u7d71\uff0c\u6709\u6f5b\u529b\u64f4\u5927\u53ef\u63a5\u53d7\u6cbb\u7642\u7684\u60a3\u8005\u7fa4\u9ad4\uff0c\u4e26\u63d0\u5347\u7642\u6548\u3002\u300d Kirtane \u91ab\u751f\u8868\u793a\uff1a\u300c\u9069\u7576\u4f7f\u7528\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u53ef\u8b93\u91ab\u751f\u5728\u5b89\u5168\u60c5\u6cc1\u4e0b\u57f7\u884c\u6975\u5ea6\u8907\u96dc\u7684\u624b\u8853\uff0c\u70ba\u4ee5\u5f80\u6cbb\u7642\u9078\u64c7\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI)\u3002\u555f\u52d5\u9019\u9805\u91dd\u5c0d\u65b0\u578b\u3001\u4f4e\u5916\u5f91\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\u88dd\u7f6e\u7684\u95dc\u9375\u6027\u96a8\u6a5f\u8a66\u9a57\uff0c\u662f\u63a8\u52d5\u90e8\u5206\u6700\u9ad8\u98a8\u96aa\u60a3\u8005\u6cbb\u7642\u9032\u5c55\u7684\u91cd\u8981\u4e00\u6b65\u3002\u300d \u5fc3\u6e90\u6027\u4f11\u514b\u6cbb\u7642\u7684\u6700\u65b0\u9032\u5c55 \u9664 SUPPORT II \u8a66\u9a57\u5916\uff0c\u516c\u53f8\u4ea6\u4e00\u76f4\u7a4d\u6975\u63a2\u7d22\u6a5f\u6703\uff0c\u4ee5\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6848\u3002\u8fd1\u671f\u65bc\u7f8e\u570b\u4ee5\u5916\u5730\u5340\u7684\u81e8\u5e8a\u75c5\u4f8b\u986f\u793a\uff0c\u9996\u6279\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u5df2\u63a1\u7528\u7d93\u76ae\u814b\u52d5\u8108\u5165\u8def\uff0c\u914d\u5408 10Fr \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u9032\u884c\u6cbb\u7642\uff0c\u4f7f\u60a3\u8005\u5728\u88dd\u7f6e\u904b\u4f5c\u671f\u9593\u80fd\u5920\u4e0b\u5e8a\u8d70\u52d5\u3002 \u9019\u4e9b\u91cc\u7a0b\u7891\u5171\u540c\u7a81\u986f\u51fa\u65b0\u4e00\u4ee3\u81e8\u6642\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u6280\u8853\u6240\u5177\u5099\u7684\u6f5b\u5728\u80fd\u529b\uff0c\u5305\u62ec\u64f4\u5c55\u6cbb\u7642\u9078\u64c7\u3001\u652f\u6301\u60a3\u8005\u6d3b\u52d5\uff0c\u4ee5\u53ca\u63a8\u52d5\u91ab\u751f\u5728\u91cd\u75c7\u60a3\u8005\u7ba1\u7406\u65b9\u9762\u7684\u9032\u4e00\u6b65\u767c\u5c55\u3002 \u5c0d\u65bc\u4ecb\u5165\u5fc3\u81df\u75c5\u5c08\u5bb6\u53ca\u5fc3\u81df\u8870\u7aed\u5c08\u79d1\u91ab\u751f\u800c\u8a00\uff0c\u5728\u7d93\u76ae\u4ecb\u5165\u5165\u8def\u5177\u5099\u9748\u6d3b\u6027\u7684\u540c\u6642\uff0c\u63d0\u4f9b\u5168\u9762\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u4e26\u8b93\u60a3\u8005\u5728\u6cbb\u7642\u671f\u9593\u4ecd\u53ef\u6d3b\u52d5\uff0c\u5747\u70ba\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u6574\u9ad4\u6cbb\u7642\u6d41\u7a0b\u7684\u91cd\u8981\u9032\u5c55\u3002 \u59d4\u4efb\u91ab\u7642\u5668\u68b0\u696d\u8cc7\u6df1\u5c08\u5bb6 D. Keith Grossman \u70ba\u7368\u7acb\u8463\u4e8b \u5728\u4e0a\u8ff0\u81e8\u5e8a\u91cc\u7a0b\u7891\u63a8\u9032\u7684\u540c\u6642\uff0cSupira \u4ea6\u5ba3\u4f48\u59d4\u4efb D. 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(Supira) \u662f\u4e00\u5bb6\u5c08\u6ce8\u65bc\u9769\u65b0\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u7684\u81e8\u5e8a\u968e\u6bb5\u516c\u53f8\uff0c\u4eca\u65e5\u5ba3\u4f48\u5df2\u7372\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\u555f\u52d5 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u3002\u8a72\u8a66\u9a57\u65e8\u5728\u70ba\u672a\u4f86\u63d0\u4ea4\u4e0a\u5e02\u524d\u6279\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u6a19\u8a8c\u8457\u516c\u53f8\u9081\u5411\u7f8e\u570b\u5e02\u5834\u7684\u91cd\u8981\u4e00\u6b65\u3002 SUPPORT II (SUpira System in\u00a0Patients Undergoing High-Risk\u00a0Percutaneous COronaRy InTervention (HRPCI)) \u662f\u4e00\u9805\u524d\u77bb\u6027\u3001\u96a8\u6a5f\u5206\u914d\u5c0d\u7167\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30\u516c\u53f8\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5728\u63a5\u53d7\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u53ca\u7642\u6548\u3002\u8a72\u7814\u7a76\u5c07\u65bc\u7f8e\u570b\u6700\u591a 40 \u500b\u91ab\u7642\u4e2d\u5fc3\u62db\u52df\u6700\u591a 385 \u540d\u60a3\u8005\uff0c\u4e26\u7531\u5169\u4f4d\u5168\u7f8e\u806f\u5e2d\u9996\u5e2d\u7814\u7a76\u54e1\u9818\u5c0e\uff0c\u5305\u62ec\u54e5\u502b\u6bd4\u4e9e\u5927\u5b78\u74e6\u683c\u6d1b\u65af\u91ab\u5b78\u9662 (Vagelos College of Physicians and Surgeons) \u53ca\u7d10\u7d04\u9577\u8001\u6703\u91ab\u9662 (New York-Presbyterian Hospital) \u91ab\u5b78\u6559\u6388 Ajay Kirtane \u91ab\u751f\uff0c\u4ee5\u53ca\u4f4d\u65bc\u4f50\u6cbb\u4e9e\u5dde\u4e9e\u7279\u862d\u5927\u7684 Piedmont Heart Institute \u4e3b\u4efb\u517c Piedmont Healthcare \u9996\u5e2d\u79d1\u5b78\u7e3d\u76e3 David Kandzari \u91ab\u751f\u3002 Kandzari \u91ab\u751f\u8868\u793a\uff1a\u300c\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u4e2d\uff0c\u662f\u5426\u63a1\u7528\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u901a\u8def\u53ef\u53ca\u6027\u3001\u5668\u68b0\u8f38\u9001\u6027\u80fd\uff0c\u4ee5\u53ca\u652f\u6301\u6548\u679c\u8207\u624b\u8853\u6548\u7387\u4e4b\u9593\u7684\u5e73\u8861\u3002\u4e00\u7a2e\u80fd\u4ee5\u66f4\u5c0f\u9ad4\u7a4d\u63d0\u4f9b\u6709\u6548\u5faa\u74b0\u652f\u6301\u7684\u7cfb\u7d71\uff0c\u6709\u6f5b\u529b\u64f4\u5927\u53ef\u63a5\u53d7\u6cbb\u7642\u7684\u60a3\u8005\u7fa4\u9ad4\uff0c\u4e26\u63d0\u5347\u7642\u6548\u3002\u300d Kirtane \u91ab\u751f\u8868\u793a\uff1a\u300c\u9069\u7576\u4f7f\u7528\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u53ef\u8b93\u91ab\u751f\u5728\u5b89\u5168\u60c5\u6cc1\u4e0b\u57f7\u884c\u6975\u5ea6\u8907\u96dc\u7684\u624b\u8853\uff0c\u70ba\u4ee5\u5f80\u6cbb\u7642\u9078\u64c7\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI)\u3002\u555f\u52d5\u9019\u9805\u91dd\u5c0d\u65b0\u578b\u3001\u4f4e\u5916\u5f91\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\u88dd\u7f6e\u7684\u95dc\u9375\u6027\u96a8\u6a5f\u8a66\u9a57\uff0c\u662f\u63a8\u52d5\u90e8\u5206\u6700\u9ad8\u98a8\u96aa\u60a3\u8005\u6cbb\u7642\u9032\u5c55\u7684\u91cd\u8981\u4e00\u6b65\u3002\u300d \u5fc3\u6e90\u6027\u4f11\u514b\u6cbb\u7642\u7684\u6700\u65b0\u9032\u5c55 \u9664 SUPPORT II \u8a66\u9a57\u5916\uff0c\u516c\u53f8\u4ea6\u4e00\u76f4\u7a4d\u6975\u63a2\u7d22\u6a5f\u6703\uff0c\u4ee5\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6848\u3002\u8fd1\u671f\u65bc\u7f8e\u570b\u4ee5\u5916\u5730\u5340\u7684\u81e8\u5e8a\u75c5\u4f8b\u986f\u793a\uff0c\u9996\u6279\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u5df2\u63a1\u7528\u7d93\u76ae\u814b\u52d5\u8108\u5165\u8def\uff0c\u914d\u5408 10Fr \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u9032\u884c\u6cbb\u7642\uff0c\u4f7f\u60a3\u8005\u5728\u88dd\u7f6e\u904b\u4f5c\u671f\u9593\u80fd\u5920\u4e0b\u5e8a\u8d70\u52d5\u3002 \u9019\u4e9b\u91cc\u7a0b\u7891\u5171\u540c\u7a81\u986f\u51fa\u65b0\u4e00\u4ee3\u81e8\u6642\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u6280\u8853\u6240\u5177\u5099\u7684\u6f5b\u5728\u80fd\u529b\uff0c\u5305\u62ec\u64f4\u5c55\u6cbb\u7642\u9078\u64c7\u3001\u652f\u6301\u60a3\u8005\u6d3b\u52d5\uff0c\u4ee5\u53ca\u63a8\u52d5\u91ab\u751f\u5728\u91cd\u75c7\u60a3\u8005\u7ba1\u7406\u65b9\u9762\u7684\u9032\u4e00\u6b65\u767c\u5c55\u3002 \u5c0d\u65bc\u4ecb\u5165\u5fc3\u81df\u75c5\u5c08\u5bb6\u53ca\u5fc3\u81df\u8870\u7aed\u5c08\u79d1\u91ab\u751f\u800c\u8a00\uff0c\u5728\u7d93\u76ae\u4ecb\u5165\u5165\u8def\u5177\u5099\u9748\u6d3b\u6027\u7684\u540c\u6642\uff0c\u63d0\u4f9b\u5168\u9762\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u4e26\u8b93\u60a3\u8005\u5728\u6cbb\u7642\u671f\u9593\u4ecd\u53ef\u6d3b\u52d5\uff0c\u5747\u70ba\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u6574\u9ad4\u6cbb\u7642\u6d41\u7a0b\u7684\u91cd\u8981\u9032\u5c55\u3002 \u59d4\u4efb\u91ab\u7642\u5668\u68b0\u696d\u8cc7\u6df1\u5c08\u5bb6 D. Keith Grossman \u70ba\u7368\u7acb\u8463\u4e8b \u5728\u4e0a\u8ff0\u81e8\u5e8a\u91cc\u7a0b\u7891\u63a8\u9032\u7684\u540c\u6642\uff0cSupira \u4ea6\u5ba3\u4f48\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703\u3002Grossman \u5148\u751f\u5728\u91ab\u7642\u79d1\u6280\u884c\u696d\u64c1\u6709 40 \u5e74\u9818\u5c0e\u7d93\u9a57\uff0c\u4e26\u66fe\u5728\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u9818\u57df\u767c\u63ee\u57fa\u672c\u4f5c\u7528\uff0c\u5c07\u6709\u52a9\u516c\u53f8\u52a0\u901f\u6e96\u5099\u9032\u5165\u5e02\u5834\u53ca\u63a8\u52d5\u696d\u52d9\u589e\u9577\u3002 Supira Medical \u7e3d\u88c1\u517c\u884c\u653f\u7e3d\u88c1 Nitin Salunke \u535a\u58eb\u8868\u793a\uff1a\u300cKeith \u517c\u5177\u71df\u904b\u7d00\u5f8b\u3001\u5546\u696d\u6d1e\u5bdf\u529b\u53ca\u7b56\u7565\u8996\u91ce\uff0c\u70ba\u516c\u53f8\u5e36\u4f86\u6975\u5177\u50f9\u503c\u7684\u7d9c\u5408\u512a\u52e2\u3002\u4ed6\u4ee5\u7368\u7acb\u8463\u4e8b\u8eab\u4efd\u52a0\u5165\u8463\u4e8b\u6703\uff0c\u9ad4\u73fe\u6211\u5011\u81f4\u529b\u6253\u9020\u4e00\u500b\u4e0d\u50c5\u5728\u81e8\u5e8a\u5c64\u9762\u5177\u5099\u8207\u5225\u4e0d\u540c\u7684\u512a\u52e2\uff0c\u4ea6\u5177\u5099\u5927\u898f\u6a21\u57f7\u884c\u80fd\u529b\u7684\u7d44\u7e54\u3002\u300d Grossman \u5148\u751f\u8868\u793a\uff1a\u300cSupira \u5df2\u5efa\u7acb\u7a69\u56fa\u7684\u81e8\u5e8a\u53ca\u6280\u8853\u57fa\u790e\uff0c\u4e26\u5728\u6301\u7e8c\u589e\u9577\u4e14\u6ef2\u900f\u7387\u4ecd\u7136\u504f\u4f4e\u7684\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u4e2d\u5177\u5099\u7368\u7279\u512a\u52e2\uff0c\u6709\u671b\u63a8\u52d5\u884c\u696d\u8b8a\u9769\u3002\u6211\u671f\u5f85\u5728\u516c\u53f8\u63a8\u9032\u95dc\u9375\u6027\u81e8\u5e8a\u8a66\u9a57\u7684\u540c\u6642\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u5354\u52a9\u5176\u6210\u70ba\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u6cbb\u7642\u9818\u57df\u4e2d\u7684\u91cd\u8981\u9818\u5148\u529b\u91cf\u3002\u300d \u95dc\u65bc Supira Medical, Inc. Supira Medical \u81f4\u529b\u958b\u767c\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD)\uff0c\u7528\u65bc\u63a5\u53d7\u4ecb\u5165\u6027\u6cbb\u7642\u7684\u9ad8\u98a8\u96aa\u60a3\u8005\uff0c\u4ee5\u53ca\u51fa\u73fe\u5fc3\u6e90\u6027\u4f11\u514b\u7684\u60a3\u8005\u3002\u622a\u81f3\u76ee\u524d\uff0cSupira \u7cfb\u7d71\u5df2\u61c9\u7528\u65bc 99 \u540d\u60a3\u8005\u3002\u5982\u6b32\u4e86\u89e3\u66f4\u591a\u6709\u95dc Supira Medical \u7684\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.supiramedical.com\u3002 \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5c0d\u65bc\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u904e\u7a0b\u4e2d\u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u4e2d\u7dad\u6301\u5fc3\u8840\u7ba1\u529f\u80fd\u5177\u6709\u91cd\u8981\u4f5c\u7528\u3002\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u901a\u5e38\u5177\u6709\u8907\u96dc\u7684\u51a0\u72c0\u52d5\u8108\u89e3\u5256\u7d50\u69cb\u3001\u8840\u6d41\u52d5\u529b\u5b78\u4e0d\u7a69\u5b9a\u53ca\u591a\u91cd\u5171\u75c5\uff1b\u800c\u5fc3\u6e90\u6027\u4f11\u514b\u5247\u662f\u4e00\u7a2e\u9ad8\u6b7b\u4ea1\u7387\u7684\u75c5\u75c7\uff0c\u60a3\u8005\u5fc3\u81df\u640f\u52d5\u7121\u529b\uff0c\u7121\u6cd5\u6709\u6548\u5c07\u8db3\u5920\u7684\u8840\u6db2\u8f38\u9001\u81f3\u91cd\u8981\u5668\u5b98\uff0c\u901a\u5e38\u7531\u5fc3\u808c\u6897\u585e\u6216\u5fc3\u81df\u8870\u7aed\u6240\u5f15\u8d77\u3002 Supira \u7cfb\u7d71\u70ba\u7814\u7a76\u6027\u91ab\u7642\u5668\u68b0\uff0c\u5c1a\u672a\u7372\u6279\u51c6\u5728\u7f8e\u570b\u6216\u5168\u7403\u4efb\u4f55\u5730\u5340\u92b7\u552e\u3002\u6839\u64da\u7f8e\u570b\u806f\u90a6\u6cd5\u5f8b\u898f\u5b9a\uff0c\u8a72\u5668\u68b0\u50c5\u9650\u7528\u65bc\u7814\u7a76\u7528\u9014\u3002 \u5a92\u9ad4\u806f\u7d61\u4eba\uff1aCraig Brandli\u5e02\u5834\u63a8\u5ee3\u526f\u7e3d\u88c1craig@supiramedical.com \u00a0","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pingtungtimes.com.tw\/?p=424842","og_locale":"zh_TW","og_type":"article","og_title":"Supira Medical \u5ba3\u4f48 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u7372 FDA \u6279\u51c6\uff0c\u4e26\u5728\u5fc3\u6e90\u6027\u4f11\u514b\u9818\u57df\u53d6\u5f97\u9032\u5c55\uff0c\u540c\u6642\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","og_description":"\u591a\u9805\u91cc\u7a0b\u7891\u7a81\u986f\u81e8\u5e8a\u9032\u5c55\u4e26\u978f\u56fa\u5546\u696d\u57fa\u790e \u52a0\u5dde\u6d1b\u65af\u52a0\u6258\u65af2026\u5e744\u67088\u65e5 \/\u7f8e\u901a\u793e\/ -- Supira Medical, Inc. (Supira) \u662f\u4e00\u5bb6\u5c08\u6ce8\u65bc\u9769\u65b0\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u7684\u81e8\u5e8a\u968e\u6bb5\u516c\u53f8\uff0c\u4eca\u65e5\u5ba3\u4f48\u5df2\u7372\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\u555f\u52d5 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u3002\u8a72\u8a66\u9a57\u65e8\u5728\u70ba\u672a\u4f86\u63d0\u4ea4\u4e0a\u5e02\u524d\u6279\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u6a19\u8a8c\u8457\u516c\u53f8\u9081\u5411\u7f8e\u570b\u5e02\u5834\u7684\u91cd\u8981\u4e00\u6b65\u3002 SUPPORT II (SUpira System in\u00a0Patients Undergoing High-Risk\u00a0Percutaneous COronaRy InTervention (HRPCI)) \u662f\u4e00\u9805\u524d\u77bb\u6027\u3001\u96a8\u6a5f\u5206\u914d\u5c0d\u7167\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30\u516c\u53f8\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5728\u63a5\u53d7\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u53ca\u7642\u6548\u3002\u8a72\u7814\u7a76\u5c07\u65bc\u7f8e\u570b\u6700\u591a 40 \u500b\u91ab\u7642\u4e2d\u5fc3\u62db\u52df\u6700\u591a 385 \u540d\u60a3\u8005\uff0c\u4e26\u7531\u5169\u4f4d\u5168\u7f8e\u806f\u5e2d\u9996\u5e2d\u7814\u7a76\u54e1\u9818\u5c0e\uff0c\u5305\u62ec\u54e5\u502b\u6bd4\u4e9e\u5927\u5b78\u74e6\u683c\u6d1b\u65af\u91ab\u5b78\u9662 (Vagelos College of Physicians and Surgeons) \u53ca\u7d10\u7d04\u9577\u8001\u6703\u91ab\u9662 (New York-Presbyterian Hospital) \u91ab\u5b78\u6559\u6388 Ajay Kirtane \u91ab\u751f\uff0c\u4ee5\u53ca\u4f4d\u65bc\u4f50\u6cbb\u4e9e\u5dde\u4e9e\u7279\u862d\u5927\u7684 Piedmont Heart Institute \u4e3b\u4efb\u517c Piedmont Healthcare \u9996\u5e2d\u79d1\u5b78\u7e3d\u76e3 David Kandzari \u91ab\u751f\u3002 Kandzari \u91ab\u751f\u8868\u793a\uff1a\u300c\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u4e2d\uff0c\u662f\u5426\u63a1\u7528\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u901a\u8def\u53ef\u53ca\u6027\u3001\u5668\u68b0\u8f38\u9001\u6027\u80fd\uff0c\u4ee5\u53ca\u652f\u6301\u6548\u679c\u8207\u624b\u8853\u6548\u7387\u4e4b\u9593\u7684\u5e73\u8861\u3002\u4e00\u7a2e\u80fd\u4ee5\u66f4\u5c0f\u9ad4\u7a4d\u63d0\u4f9b\u6709\u6548\u5faa\u74b0\u652f\u6301\u7684\u7cfb\u7d71\uff0c\u6709\u6f5b\u529b\u64f4\u5927\u53ef\u63a5\u53d7\u6cbb\u7642\u7684\u60a3\u8005\u7fa4\u9ad4\uff0c\u4e26\u63d0\u5347\u7642\u6548\u3002\u300d Kirtane \u91ab\u751f\u8868\u793a\uff1a\u300c\u9069\u7576\u4f7f\u7528\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u53ef\u8b93\u91ab\u751f\u5728\u5b89\u5168\u60c5\u6cc1\u4e0b\u57f7\u884c\u6975\u5ea6\u8907\u96dc\u7684\u624b\u8853\uff0c\u70ba\u4ee5\u5f80\u6cbb\u7642\u9078\u64c7\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI)\u3002\u555f\u52d5\u9019\u9805\u91dd\u5c0d\u65b0\u578b\u3001\u4f4e\u5916\u5f91\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\u88dd\u7f6e\u7684\u95dc\u9375\u6027\u96a8\u6a5f\u8a66\u9a57\uff0c\u662f\u63a8\u52d5\u90e8\u5206\u6700\u9ad8\u98a8\u96aa\u60a3\u8005\u6cbb\u7642\u9032\u5c55\u7684\u91cd\u8981\u4e00\u6b65\u3002\u300d \u5fc3\u6e90\u6027\u4f11\u514b\u6cbb\u7642\u7684\u6700\u65b0\u9032\u5c55 \u9664 SUPPORT II \u8a66\u9a57\u5916\uff0c\u516c\u53f8\u4ea6\u4e00\u76f4\u7a4d\u6975\u63a2\u7d22\u6a5f\u6703\uff0c\u4ee5\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6848\u3002\u8fd1\u671f\u65bc\u7f8e\u570b\u4ee5\u5916\u5730\u5340\u7684\u81e8\u5e8a\u75c5\u4f8b\u986f\u793a\uff0c\u9996\u6279\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u5df2\u63a1\u7528\u7d93\u76ae\u814b\u52d5\u8108\u5165\u8def\uff0c\u914d\u5408 10Fr \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u9032\u884c\u6cbb\u7642\uff0c\u4f7f\u60a3\u8005\u5728\u88dd\u7f6e\u904b\u4f5c\u671f\u9593\u80fd\u5920\u4e0b\u5e8a\u8d70\u52d5\u3002 \u9019\u4e9b\u91cc\u7a0b\u7891\u5171\u540c\u7a81\u986f\u51fa\u65b0\u4e00\u4ee3\u81e8\u6642\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u6280\u8853\u6240\u5177\u5099\u7684\u6f5b\u5728\u80fd\u529b\uff0c\u5305\u62ec\u64f4\u5c55\u6cbb\u7642\u9078\u64c7\u3001\u652f\u6301\u60a3\u8005\u6d3b\u52d5\uff0c\u4ee5\u53ca\u63a8\u52d5\u91ab\u751f\u5728\u91cd\u75c7\u60a3\u8005\u7ba1\u7406\u65b9\u9762\u7684\u9032\u4e00\u6b65\u767c\u5c55\u3002 \u5c0d\u65bc\u4ecb\u5165\u5fc3\u81df\u75c5\u5c08\u5bb6\u53ca\u5fc3\u81df\u8870\u7aed\u5c08\u79d1\u91ab\u751f\u800c\u8a00\uff0c\u5728\u7d93\u76ae\u4ecb\u5165\u5165\u8def\u5177\u5099\u9748\u6d3b\u6027\u7684\u540c\u6642\uff0c\u63d0\u4f9b\u5168\u9762\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u4e26\u8b93\u60a3\u8005\u5728\u6cbb\u7642\u671f\u9593\u4ecd\u53ef\u6d3b\u52d5\uff0c\u5747\u70ba\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u6574\u9ad4\u6cbb\u7642\u6d41\u7a0b\u7684\u91cd\u8981\u9032\u5c55\u3002 \u59d4\u4efb\u91ab\u7642\u5668\u68b0\u696d\u8cc7\u6df1\u5c08\u5bb6 D. Keith Grossman \u70ba\u7368\u7acb\u8463\u4e8b \u5728\u4e0a\u8ff0\u81e8\u5e8a\u91cc\u7a0b\u7891\u63a8\u9032\u7684\u540c\u6642\uff0cSupira \u4ea6\u5ba3\u4f48\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703\u3002Grossman \u5148\u751f\u5728\u91ab\u7642\u79d1\u6280\u884c\u696d\u64c1\u6709 40 \u5e74\u9818\u5c0e\u7d93\u9a57\uff0c\u4e26\u66fe\u5728\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u9818\u57df\u767c\u63ee\u57fa\u672c\u4f5c\u7528\uff0c\u5c07\u6709\u52a9\u516c\u53f8\u52a0\u901f\u6e96\u5099\u9032\u5165\u5e02\u5834\u53ca\u63a8\u52d5\u696d\u52d9\u589e\u9577\u3002 Supira Medical \u7e3d\u88c1\u517c\u884c\u653f\u7e3d\u88c1 Nitin Salunke \u535a\u58eb\u8868\u793a\uff1a\u300cKeith \u517c\u5177\u71df\u904b\u7d00\u5f8b\u3001\u5546\u696d\u6d1e\u5bdf\u529b\u53ca\u7b56\u7565\u8996\u91ce\uff0c\u70ba\u516c\u53f8\u5e36\u4f86\u6975\u5177\u50f9\u503c\u7684\u7d9c\u5408\u512a\u52e2\u3002\u4ed6\u4ee5\u7368\u7acb\u8463\u4e8b\u8eab\u4efd\u52a0\u5165\u8463\u4e8b\u6703\uff0c\u9ad4\u73fe\u6211\u5011\u81f4\u529b\u6253\u9020\u4e00\u500b\u4e0d\u50c5\u5728\u81e8\u5e8a\u5c64\u9762\u5177\u5099\u8207\u5225\u4e0d\u540c\u7684\u512a\u52e2\uff0c\u4ea6\u5177\u5099\u5927\u898f\u6a21\u57f7\u884c\u80fd\u529b\u7684\u7d44\u7e54\u3002\u300d Grossman \u5148\u751f\u8868\u793a\uff1a\u300cSupira \u5df2\u5efa\u7acb\u7a69\u56fa\u7684\u81e8\u5e8a\u53ca\u6280\u8853\u57fa\u790e\uff0c\u4e26\u5728\u6301\u7e8c\u589e\u9577\u4e14\u6ef2\u900f\u7387\u4ecd\u7136\u504f\u4f4e\u7684\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u4e2d\u5177\u5099\u7368\u7279\u512a\u52e2\uff0c\u6709\u671b\u63a8\u52d5\u884c\u696d\u8b8a\u9769\u3002\u6211\u671f\u5f85\u5728\u516c\u53f8\u63a8\u9032\u95dc\u9375\u6027\u81e8\u5e8a\u8a66\u9a57\u7684\u540c\u6642\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u5354\u52a9\u5176\u6210\u70ba\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u6cbb\u7642\u9818\u57df\u4e2d\u7684\u91cd\u8981\u9818\u5148\u529b\u91cf\u3002\u300d \u95dc\u65bc Supira Medical, Inc. Supira Medical \u81f4\u529b\u958b\u767c\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD)\uff0c\u7528\u65bc\u63a5\u53d7\u4ecb\u5165\u6027\u6cbb\u7642\u7684\u9ad8\u98a8\u96aa\u60a3\u8005\uff0c\u4ee5\u53ca\u51fa\u73fe\u5fc3\u6e90\u6027\u4f11\u514b\u7684\u60a3\u8005\u3002\u622a\u81f3\u76ee\u524d\uff0cSupira \u7cfb\u7d71\u5df2\u61c9\u7528\u65bc 99 \u540d\u60a3\u8005\u3002\u5982\u6b32\u4e86\u89e3\u66f4\u591a\u6709\u95dc Supira Medical \u7684\u8cc7\u8a0a\uff0c\u8acb\u700f\u89bd www.supiramedical.com\u3002 \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5c0d\u65bc\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u904e\u7a0b\u4e2d\u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u4e2d\u7dad\u6301\u5fc3\u8840\u7ba1\u529f\u80fd\u5177\u6709\u91cd\u8981\u4f5c\u7528\u3002\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u901a\u5e38\u5177\u6709\u8907\u96dc\u7684\u51a0\u72c0\u52d5\u8108\u89e3\u5256\u7d50\u69cb\u3001\u8840\u6d41\u52d5\u529b\u5b78\u4e0d\u7a69\u5b9a\u53ca\u591a\u91cd\u5171\u75c5\uff1b\u800c\u5fc3\u6e90\u6027\u4f11\u514b\u5247\u662f\u4e00\u7a2e\u9ad8\u6b7b\u4ea1\u7387\u7684\u75c5\u75c7\uff0c\u60a3\u8005\u5fc3\u81df\u640f\u52d5\u7121\u529b\uff0c\u7121\u6cd5\u6709\u6548\u5c07\u8db3\u5920\u7684\u8840\u6db2\u8f38\u9001\u81f3\u91cd\u8981\u5668\u5b98\uff0c\u901a\u5e38\u7531\u5fc3\u808c\u6897\u585e\u6216\u5fc3\u81df\u8870\u7aed\u6240\u5f15\u8d77\u3002 Supira \u7cfb\u7d71\u70ba\u7814\u7a76\u6027\u91ab\u7642\u5668\u68b0\uff0c\u5c1a\u672a\u7372\u6279\u51c6\u5728\u7f8e\u570b\u6216\u5168\u7403\u4efb\u4f55\u5730\u5340\u92b7\u552e\u3002\u6839\u64da\u7f8e\u570b\u806f\u90a6\u6cd5\u5f8b\u898f\u5b9a\uff0c\u8a72\u5668\u68b0\u50c5\u9650\u7528\u65bc\u7814\u7a76\u7528\u9014\u3002 \u5a92\u9ad4\u806f\u7d61\u4eba\uff1aCraig Brandli\u5e02\u5834\u63a8\u5ee3\u526f\u7e3d\u88c1craig@supiramedical.com \u00a0","og_url":"https:\/\/pingtungtimes.com.tw\/?p=424842","og_site_name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","article_publisher":"https:\/\/www.facebook.com\/pingtungnews","article_published_time":"2026-04-08T12:03:00+00:00","og_image":[{"width":3000,"height":1990,"url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","type":"image\/jpeg"}],"author":"\u7f8e\u901a\u793e","twitter_card":"summary_large_image","twitter_misc":{"\u4f5c\u8005:":"\u7f8e\u901a\u793e"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"NewsArticle","@id":"https:\/\/pingtungtimes.com.tw\/?p=424842#article","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=424842"},"author":{"name":"\u7f8e\u901a\u793e","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/person\/683b937f29ec1537972f6c41e22a2cf3"},"headline":"Supira Medical \u5ba3\u4f48 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u7372 FDA \u6279\u51c6\uff0c\u4e26\u5728\u5fc3\u6e90\u6027\u4f11\u514b\u9818\u57df\u53d6\u5f97\u9032\u5c55\uff0c\u540c\u6642\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703","datePublished":"2026-04-08T12:03:00+00:00","mainEntityOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=424842"},"wordCount":97,"publisher":{"@id":"https:\/\/pingtungtimes.com.tw\/#organization"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=424842#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2026\/04\/SupiraMedical_Logo_Logo_Logo.jpg","articleSection":["\u7f8e\u901a\u793e"],"inLanguage":"zh-TW"},{"@type":"WebPage","@id":"https:\/\/pingtungtimes.com.tw\/?p=424842","url":"https:\/\/pingtungtimes.com.tw\/?p=424842","name":"Supira Medical \u5ba3\u4f48 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u7372 FDA \u6279\u51c6\uff0c\u4e26\u5728\u5fc3\u6e90\u6027\u4f11\u514b\u9818\u57df\u53d6\u5f97\u9032\u5c55\uff0c\u540c\u6642\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=424842#primaryimage"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=424842#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2026\/04\/SupiraMedical_Logo_Logo_Logo.jpg","datePublished":"2026-04-08T12:03:00+00:00","description":"\u591a\u9805\u91cc\u7a0b\u7891\u7a81\u986f\u81e8\u5e8a\u9032\u5c55\u4e26\u978f\u56fa\u5546\u696d\u57fa\u790e \u52a0\u5dde\u6d1b\u65af\u52a0\u6258\u65af2026\u5e744\u67088\u65e5 \/\u7f8e\u901a\u793e\/ -- Supira Medical, Inc. (Supira) \u662f\u4e00\u5bb6\u5c08\u6ce8\u65bc\u9769\u65b0\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u7684\u81e8\u5e8a\u968e\u6bb5\u516c\u53f8\uff0c\u4eca\u65e5\u5ba3\u4f48\u5df2\u7372\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u6279\u51c6\u555f\u52d5 SUPPORT II \u95dc\u9375\u6027\u8a66\u9a57\u3002\u8a72\u8a66\u9a57\u65e8\u5728\u70ba\u672a\u4f86\u63d0\u4ea4\u4e0a\u5e02\u524d\u6279\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u6a19\u8a8c\u8457\u516c\u53f8\u9081\u5411\u7f8e\u570b\u5e02\u5834\u7684\u91cd\u8981\u4e00\u6b65\u3002 SUPPORT II (SUpira System in\u00a0Patients Undergoing High-Risk\u00a0Percutaneous COronaRy InTervention (HRPCI)) \u662f\u4e00\u9805\u524d\u77bb\u6027\u3001\u96a8\u6a5f\u5206\u914d\u5c0d\u7167\u7814\u7a76\uff0c\u65e8\u5728\u8a55\u4f30\u516c\u53f8\u65b0\u4e00\u4ee3\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5728\u63a5\u53d7\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u60a3\u8005\u4e2d\u7684\u5b89\u5168\u6027\u53ca\u7642\u6548\u3002\u8a72\u7814\u7a76\u5c07\u65bc\u7f8e\u570b\u6700\u591a 40 \u500b\u91ab\u7642\u4e2d\u5fc3\u62db\u52df\u6700\u591a 385 \u540d\u60a3\u8005\uff0c\u4e26\u7531\u5169\u4f4d\u5168\u7f8e\u806f\u5e2d\u9996\u5e2d\u7814\u7a76\u54e1\u9818\u5c0e\uff0c\u5305\u62ec\u54e5\u502b\u6bd4\u4e9e\u5927\u5b78\u74e6\u683c\u6d1b\u65af\u91ab\u5b78\u9662 (Vagelos College of Physicians and Surgeons) \u53ca\u7d10\u7d04\u9577\u8001\u6703\u91ab\u9662 (New York-Presbyterian Hospital) \u91ab\u5b78\u6559\u6388 Ajay Kirtane \u91ab\u751f\uff0c\u4ee5\u53ca\u4f4d\u65bc\u4f50\u6cbb\u4e9e\u5dde\u4e9e\u7279\u862d\u5927\u7684 Piedmont Heart Institute \u4e3b\u4efb\u517c Piedmont Healthcare \u9996\u5e2d\u79d1\u5b78\u7e3d\u76e3 David Kandzari \u91ab\u751f\u3002 Kandzari \u91ab\u751f\u8868\u793a\uff1a\u300c\u5728\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u4e2d\uff0c\u662f\u5426\u63a1\u7528\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u5f80\u5f80\u53d6\u6c7a\u65bc\u901a\u8def\u53ef\u53ca\u6027\u3001\u5668\u68b0\u8f38\u9001\u6027\u80fd\uff0c\u4ee5\u53ca\u652f\u6301\u6548\u679c\u8207\u624b\u8853\u6548\u7387\u4e4b\u9593\u7684\u5e73\u8861\u3002\u4e00\u7a2e\u80fd\u4ee5\u66f4\u5c0f\u9ad4\u7a4d\u63d0\u4f9b\u6709\u6548\u5faa\u74b0\u652f\u6301\u7684\u7cfb\u7d71\uff0c\u6709\u6f5b\u529b\u64f4\u5927\u53ef\u63a5\u53d7\u6cbb\u7642\u7684\u60a3\u8005\u7fa4\u9ad4\uff0c\u4e26\u63d0\u5347\u7642\u6548\u3002\u300d Kirtane \u91ab\u751f\u8868\u793a\uff1a\u300c\u9069\u7576\u4f7f\u7528\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u53ef\u8b93\u91ab\u751f\u5728\u5b89\u5168\u60c5\u6cc1\u4e0b\u57f7\u884c\u6975\u5ea6\u8907\u96dc\u7684\u624b\u8853\uff0c\u70ba\u4ee5\u5f80\u6cbb\u7642\u9078\u64c7\u6709\u9650\u7684\u60a3\u8005\u63d0\u4f9b\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI)\u3002\u555f\u52d5\u9019\u9805\u91dd\u5c0d\u65b0\u578b\u3001\u4f4e\u5916\u5f91\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\u88dd\u7f6e\u7684\u95dc\u9375\u6027\u96a8\u6a5f\u8a66\u9a57\uff0c\u662f\u63a8\u52d5\u90e8\u5206\u6700\u9ad8\u98a8\u96aa\u60a3\u8005\u6cbb\u7642\u9032\u5c55\u7684\u91cd\u8981\u4e00\u6b65\u3002\u300d \u5fc3\u6e90\u6027\u4f11\u514b\u6cbb\u7642\u7684\u6700\u65b0\u9032\u5c55 \u9664 SUPPORT II \u8a66\u9a57\u5916\uff0c\u516c\u53f8\u4ea6\u4e00\u76f4\u7a4d\u6975\u63a2\u7d22\u6a5f\u6703\uff0c\u4ee5\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u7684\u6cbb\u7642\u65b9\u6848\u3002\u8fd1\u671f\u65bc\u7f8e\u570b\u4ee5\u5916\u5730\u5340\u7684\u81e8\u5e8a\u75c5\u4f8b\u986f\u793a\uff0c\u9996\u6279\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u5df2\u63a1\u7528\u7d93\u76ae\u814b\u52d5\u8108\u5165\u8def\uff0c\u914d\u5408 10Fr \u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u9032\u884c\u6cbb\u7642\uff0c\u4f7f\u60a3\u8005\u5728\u88dd\u7f6e\u904b\u4f5c\u671f\u9593\u80fd\u5920\u4e0b\u5e8a\u8d70\u52d5\u3002 \u9019\u4e9b\u91cc\u7a0b\u7891\u5171\u540c\u7a81\u986f\u51fa\u65b0\u4e00\u4ee3\u81e8\u6642\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u6280\u8853\u6240\u5177\u5099\u7684\u6f5b\u5728\u80fd\u529b\uff0c\u5305\u62ec\u64f4\u5c55\u6cbb\u7642\u9078\u64c7\u3001\u652f\u6301\u60a3\u8005\u6d3b\u52d5\uff0c\u4ee5\u53ca\u63a8\u52d5\u91ab\u751f\u5728\u91cd\u75c7\u60a3\u8005\u7ba1\u7406\u65b9\u9762\u7684\u9032\u4e00\u6b65\u767c\u5c55\u3002 \u5c0d\u65bc\u4ecb\u5165\u5fc3\u81df\u75c5\u5c08\u5bb6\u53ca\u5fc3\u81df\u8870\u7aed\u5c08\u79d1\u91ab\u751f\u800c\u8a00\uff0c\u5728\u7d93\u76ae\u4ecb\u5165\u5165\u8def\u5177\u5099\u9748\u6d3b\u6027\u7684\u540c\u6642\uff0c\u63d0\u4f9b\u5168\u9762\u8840\u6d41\u52d5\u529b\u5b78\u652f\u6301\uff0c\u4e26\u8b93\u60a3\u8005\u5728\u6cbb\u7642\u671f\u9593\u4ecd\u53ef\u6d3b\u52d5\uff0c\u5747\u70ba\u6539\u5584\u5fc3\u6e90\u6027\u4f11\u514b\u6574\u9ad4\u6cbb\u7642\u6d41\u7a0b\u7684\u91cd\u8981\u9032\u5c55\u3002 \u59d4\u4efb\u91ab\u7642\u5668\u68b0\u696d\u8cc7\u6df1\u5c08\u5bb6 D. Keith Grossman \u70ba\u7368\u7acb\u8463\u4e8b \u5728\u4e0a\u8ff0\u81e8\u5e8a\u91cc\u7a0b\u7891\u63a8\u9032\u7684\u540c\u6642\uff0cSupira \u4ea6\u5ba3\u4f48\u59d4\u4efb D. Keith Grossman \u52a0\u5165\u8463\u4e8b\u6703\u3002Grossman \u5148\u751f\u5728\u91ab\u7642\u79d1\u6280\u884c\u696d\u64c1\u6709 40 \u5e74\u9818\u5c0e\u7d93\u9a57\uff0c\u4e26\u66fe\u5728\u6a5f\u68b0\u5faa\u74b0\u8f14\u52a9\u9818\u57df\u767c\u63ee\u57fa\u672c\u4f5c\u7528\uff0c\u5c07\u6709\u52a9\u516c\u53f8\u52a0\u901f\u6e96\u5099\u9032\u5165\u5e02\u5834\u53ca\u63a8\u52d5\u696d\u52d9\u589e\u9577\u3002 Supira Medical \u7e3d\u88c1\u517c\u884c\u653f\u7e3d\u88c1 Nitin Salunke \u535a\u58eb\u8868\u793a\uff1a\u300cKeith \u517c\u5177\u71df\u904b\u7d00\u5f8b\u3001\u5546\u696d\u6d1e\u5bdf\u529b\u53ca\u7b56\u7565\u8996\u91ce\uff0c\u70ba\u516c\u53f8\u5e36\u4f86\u6975\u5177\u50f9\u503c\u7684\u7d9c\u5408\u512a\u52e2\u3002\u4ed6\u4ee5\u7368\u7acb\u8463\u4e8b\u8eab\u4efd\u52a0\u5165\u8463\u4e8b\u6703\uff0c\u9ad4\u73fe\u6211\u5011\u81f4\u529b\u6253\u9020\u4e00\u500b\u4e0d\u50c5\u5728\u81e8\u5e8a\u5c64\u9762\u5177\u5099\u8207\u5225\u4e0d\u540c\u7684\u512a\u52e2\uff0c\u4ea6\u5177\u5099\u5927\u898f\u6a21\u57f7\u884c\u80fd\u529b\u7684\u7d44\u7e54\u3002\u300d Grossman \u5148\u751f\u8868\u793a\uff1a\u300cSupira \u5df2\u5efa\u7acb\u7a69\u56fa\u7684\u81e8\u5e8a\u53ca\u6280\u8853\u57fa\u790e\uff0c\u4e26\u5728\u6301\u7e8c\u589e\u9577\u4e14\u6ef2\u900f\u7387\u4ecd\u7136\u504f\u4f4e\u7684\u7d93\u76ae\u5fc3\u5ba4\u8f14\u52a9\u88dd\u7f6e (pVAD) \u5e02\u5834\u4e2d\u5177\u5099\u7368\u7279\u512a\u52e2\uff0c\u6709\u671b\u63a8\u52d5\u884c\u696d\u8b8a\u9769\u3002\u6211\u671f\u5f85\u5728\u516c\u53f8\u63a8\u9032\u95dc\u9375\u6027\u81e8\u5e8a\u8a66\u9a57\u7684\u540c\u6642\u63d0\u4f9b\u652f\u6301\uff0c\u4e26\u5354\u52a9\u5176\u6210\u70ba\u9ad8\u98a8\u96aa\u7d93\u76ae\u51a0\u72c0\u52d5\u8108\u4ecb\u5165\u6cbb\u7642 (HRPCI) \u53ca\u5fc3\u6e90\u6027\u4f11\u514b\u60a3\u8005\u6cbb\u7642\u9818\u57df\u4e2d\u7684\u91cd\u8981\u9818\u5148\u529b\u91cf\u3002\u300d \u95dc\u65bc Supira Medical, Inc. 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