{"id":228873,"date":"2024-04-03T18:20:00","date_gmt":"2024-04-03T10:20:00","guid":{"rendered":"https:\/\/pingtungtimes.com.tw\/?p=228873"},"modified":"2024-04-03T18:20:00","modified_gmt":"2024-04-03T10:20:00","slug":"concept-medical-%e5%b7%b2%e7%8d%b2%e7%be%8e%e5%9c%8b-fda-%e5%b0%8d-magictouch-avf-%e9%81%a9%e6%87%89%e7%97%87%e7%9a%84-ide-%e6%a0%b8%e5%87%86%ef%bc%8c%e9%80%99%e6%98%af-magictouch-%e7%94%a2%e5%93%81","status":"publish","type":"post","link":"https:\/\/pingtungtimes.com.tw\/?p=228873","title":{"rendered":"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6"},"content":{"rendered":"<div>\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1926812\/4057769\/Concept_Medical_Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\">\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e02<\/span><span class=\"legendSpanClass\">2024\u5e744\u67083\u65e5<\/span> \/\u7f8e\u901a\u793e\/ &#8212; Concept Medical \u63a8\u51fa\u7684 MagicTouch AVF\u2014\u2014\u897f\u7f85\u83ab\u65af\u5857\u5c64\u7403\u56ca (DCB) \u5c0e\u7ba1\u2014\u2014\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u7269\u53ca\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u300cIDE \u6838\u51c6\u300d\uff0c\u5176\u5c07\u88ab\u7528\u65bc\u555f\u52d5\u4e00\u9805\u81e8\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1\u72f9\u7a84\u75c5\u8b8a\u3002<\/p>\n<div id=\"prni_dvprnejpg7710left\" dir=\"ltr\" style=\"TEXT-ALIGN: center; WIDTH: 100%\">   <span>US FDA IDE approval to initiate clinical study of Concept Medical&#8217;s MagicTouch AVF, a Sirolimus drug-coated balloon (DCB) catheter, for managing stenotic lesions of Arteriovenous Fistula in Chronic Renal Failure.<\/span>  <\/div>\n<p><a href=\"https:\/\/www.conceptmedical.com\/\" target=\"_blank\" rel=\"nofollow noopener\">Concept Medical<\/a>\u00a0\u662f\u5275\u65b0\u91ab\u7642\u5668\u6750\u6280\u8853\u7684\u9818\u5148\u4f01\u696d\uff0c\u5ba3\u4f48\u5176 <a href=\"https:\/\/www.conceptmedical.com\/product\/magic-touch-avf\/\" target=\"_blank\" rel=\"nofollow noopener\">MagicTouch AVF<\/a>\u00a0\u7372\u5f97\u7f8e\u570b\u00a0FDA\u00a0\u7a81\u7834\u6027\u8a8d\u5b9a\u7684\u7814\u7a76\u578b\u5668\u68b0\u8c41\u514d\u00a0(IDE) \u6838\u51c6\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1 (AVF) \u72f9\u7a84\u75c5\u8b8a\u3002<\/p>\n<p>\u516c\u53f8\u7684\u00a0MagicTouch \u7522\u54c1\u7d44\u5408\u5148\u524d\u5df2\u7372\u5f97\u7f8e\u570b\u00a0FDA \u7684\u5176\u4ed6\u56db\u9805\u00a0IDE \u6838\u51c6\uff0c\u7528\u65bc\u4e0d\u540c\u7684\u9069\u61c9\u75c7\u3002AVF \u9069\u61c9\u75c7\u7684\u6700\u65b0\u00a0IDE \u6838\u51c6\u662f\u516c\u53f8\u9023\u7e8c\u7372\u5f97\u7684\u7b2c 5 \u500b\u00a0IDE \u6838\u51c6\u3002<\/p>\n<p>\u7f8e\u570b\u00a0FDA \u7684\u8a72\u9805 IDE \u6838\u51c6\u8b93\u00a0Concept Medical \u80fd\u958b\u5c55\u95dc\u9375\u6027\u81e8\u5e8a\u7814\u7a76\uff0c\u6536\u96c6 MagicTouch \u897f\u7f85\u83ab\u53f8\u5857\u5c64\u7403\u56ca\u5c0e\u7ba1\u5728\u52d5\u975c\u8108\u763b\u7ba1\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8cc7\u6599\uff0c\u70ba\u5c07\u4f86\u5728\u7f8e\u570b\u7684\u4e0a\u5e02\u524d\u6838\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u63f4\u3002<\/p>\n<p>\u6162\u6027\u814e\u8870\u7aed\u60a3\u8005\u9700\u8981\u9032\u884c\u591a\u6b21\u8840\u6db2\u900f\u6790\u6cbb\u7642\uff0c\u9019\u5f80\u5f80\u6703\u5c0e\u81f4\u7528\u65bc\u6cbb\u7642\u7684\u52d5\u975c\u8108\u763b\u7ba1\u53cd\u8986\u963b\u585e\u3002MagicTouch AVF \u88ab\u63d0\u8b70\u7528\u65bc\u8655\u7406\u52d5\u975c\u8108\u763b\u7ba1\u7684\u72f9\u7a84\u75c5\u8b8a\uff0c\u5176\u63d0\u4f9b\u4e86\u4e00\u7a2e\u65b0\u65b9\u6cd5\uff0c\u6709\u671b\u6539\u5584\u814e\u8870\u7aed\u60a3\u8005\u7dad\u6301\u751f\u547d\u7684\u6240\u9700\u7684\u8840\u6db2\u900f\u6790\u7642\u6cd5\u7684\u7642\u6548\u3002\u9019\u9805\u6700\u65b0\u6838\u51c6\u5f37\u8abf\u4e86\u00a0Concept Medical \u5728\u7ba1\u7406\u72f9\u7a84\u52d5\u8108\u75c5\u8b8a\u65b9\u9762\u8ffd\u6c42\u5353\u8d8a\u548c\u5275\u65b0\uff0c\u4ee5\u6539\u5584\u75c5\u60a3\u7167\u8b77\u548c\u751f\u6d3b\u54c1\u8cea\u7684\u627f\u8afe\u3002<\/p>\n<p>Concept Medical \u5275\u8fa6\u4eba <span class=\"xn-person\">Manish Doshi<\/span> \u535a\u58eb\u8868\u793a\uff1a\u300c\u9019\u9805\u6838\u51c6\u4e0d\u50c5\u8b49\u660e\u4e86\u6211\u5011\u5c0d\u5275\u65b0\u7684\u4e0d\u61c8\u8ffd\u6c42\uff0c\u4ea6\u6a19\u8a8c\u8457\u6211\u5011\u91cd\u65b0\u5b9a\u7fa9\u8840\u6db2\u900f\u6790\u60a3\u8005\u6cbb\u7642\u683c\u5c40\u7684\u95dc\u9375\u4e00\u6b65\u3002\u6211\u5011\u671f\u5f85 MagicTouch AVF \u5c0d\u75c5\u60a3\u7167\u8b77\u7522\u751f\u7a4d\u6975\u5f71\u97ff\uff0c\u4e26\u5c0d\u5373\u5c07\u958b\u5c55\u7684\u81e8\u5e8a\u8a66\u9a57\u611f\u5230\u8208\u596e\u3002\u300d<\/p>\n<p>Concept Medical \u81f4\u529b\u65bc\u63d0\u51fa\u958b\u5275\u6027\u89e3\u6c7a\u65b9\u6848\uff0c\u6eff\u8db3\u60a3\u8005\u672a\u6eff\u8db3\u7684\u9700\u6c42\u3002\u516c\u53f8\u71b1\u5207\u671f\u5f85\u5728\u4e0b\u500b\u6708\u555f\u52d5 <a href=\"https:\/\/www.conceptmedical.com\/product\/magic-touch\/\" target=\"_blank\" rel=\"nofollow noopener\">MagicTouch SCB<\/a>\u00a0\u7684\u00a0AVF IDE \u81e8\u5e8a\u8a66\u9a57\uff0c\u4e26\u6309\u8a08\u5283\u958b\u59cb\u5728\u7f8e\u570b\u70ba\u76ee\u524d\u5df2\u6838\u51c6\u7684\u00a0MagicTouch \u7522\u54c1\u9032\u884c\u5176\u4ed6 IDE \u8a66\u9a57\u7684\u62db\u52df\u5de5\u4f5c\u3002Concept Medical \u5c08\u6ce8\u65bc\u900f\u904e\u5275\u65b0\u63a8\u52d5\u75c5\u60a3\u7167\u8b77\uff0c\u5c07\u7e7c\u7e8c\u81f4\u529b\u65bc\u6539\u5584\u5168\u7403\u75c5\u60a3\u7684\u751f\u6d3b\u3002<\/p>\n<p><b><u>\u95dc\u65bc <\/u><\/b><b><u>Concept Medical<\/u><\/b><b><u>\uff1a<\/u><\/b><\/p>\n<p>Concept Medical \u7e3d\u90e8\u4f4d\u65bc\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e02\uff0c\u696d\u52d9\u904d\u53ca\u5168\u7403\u3002CM \u5c08\u6ce8\u65bc\u958b\u767c\u6cbb\u7642\u8840\u7ba1\u548c\u975e\u8840\u7ba1\u75be\u75c5\u7684\u5275\u65b0\u85e5\u7269\u8f38\u9001\u6280\u8853\uff0c\u5229\u7528\u7368\u7279\u7684\u6280\u8853\u548c\u7522\u54c1\u7d44\u5408\u4ee5\u53ca\u5c08\u6709\u7684\u5857\u5c64\u6280\u8853\uff0c\u5c07\u85e5\u7269\u8f38\u9001\u81f3\u8840\u7ba1\u8154\u9762\u3002<\/p>\n<p>\u5982\u6b32\u9032\u4e00\u6b65\u4e86\u89e3\uff0c\u8acb\u700f\u89bd\u00a0[<a href=\"http:\/\/www.conceptmedical.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.conceptmedical.com<\/a>]<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e022024\u5e744\u6708&#8230;<\/p>\n","protected":false},"author":16,"featured_media":228874,"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-228873","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-40567"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831<\/title>\n<meta name=\"description\" content=\"\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e022024\u5e744\u67083\u65e5 \/\u7f8e\u901a\u793e\/ -- Concept Medical \u63a8\u51fa\u7684 MagicTouch AVF\u2014\u2014\u897f\u7f85\u83ab\u65af\u5857\u5c64\u7403\u56ca (DCB) \u5c0e\u7ba1\u2014\u2014\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u7269\u53ca\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u300cIDE \u6838\u51c6\u300d\uff0c\u5176\u5c07\u88ab\u7528\u65bc\u555f\u52d5\u4e00\u9805\u81e8\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1\u72f9\u7a84\u75c5\u8b8a\u3002      US FDA IDE approval to initiate clinical study of Concept Medical&#039;s MagicTouch AVF, a Sirolimus drug-coated balloon (DCB) catheter, for managing stenotic lesions of Arteriovenous Fistula in Chronic Renal Failure.  Concept Medical\u00a0\u662f\u5275\u65b0\u91ab\u7642\u5668\u6750\u6280\u8853\u7684\u9818\u5148\u4f01\u696d\uff0c\u5ba3\u4f48\u5176 MagicTouch AVF\u00a0\u7372\u5f97\u7f8e\u570b\u00a0FDA\u00a0\u7a81\u7834\u6027\u8a8d\u5b9a\u7684\u7814\u7a76\u578b\u5668\u68b0\u8c41\u514d\u00a0(IDE) \u6838\u51c6\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1 (AVF) \u72f9\u7a84\u75c5\u8b8a\u3002 \u516c\u53f8\u7684\u00a0MagicTouch \u7522\u54c1\u7d44\u5408\u5148\u524d\u5df2\u7372\u5f97\u7f8e\u570b\u00a0FDA \u7684\u5176\u4ed6\u56db\u9805\u00a0IDE \u6838\u51c6\uff0c\u7528\u65bc\u4e0d\u540c\u7684\u9069\u61c9\u75c7\u3002AVF \u9069\u61c9\u75c7\u7684\u6700\u65b0\u00a0IDE \u6838\u51c6\u662f\u516c\u53f8\u9023\u7e8c\u7372\u5f97\u7684\u7b2c 5 \u500b\u00a0IDE \u6838\u51c6\u3002 \u7f8e\u570b\u00a0FDA \u7684\u8a72\u9805 IDE \u6838\u51c6\u8b93\u00a0Concept Medical \u80fd\u958b\u5c55\u95dc\u9375\u6027\u81e8\u5e8a\u7814\u7a76\uff0c\u6536\u96c6 MagicTouch \u897f\u7f85\u83ab\u53f8\u5857\u5c64\u7403\u56ca\u5c0e\u7ba1\u5728\u52d5\u975c\u8108\u763b\u7ba1\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8cc7\u6599\uff0c\u70ba\u5c07\u4f86\u5728\u7f8e\u570b\u7684\u4e0a\u5e02\u524d\u6838\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u63f4\u3002 \u6162\u6027\u814e\u8870\u7aed\u60a3\u8005\u9700\u8981\u9032\u884c\u591a\u6b21\u8840\u6db2\u900f\u6790\u6cbb\u7642\uff0c\u9019\u5f80\u5f80\u6703\u5c0e\u81f4\u7528\u65bc\u6cbb\u7642\u7684\u52d5\u975c\u8108\u763b\u7ba1\u53cd\u8986\u963b\u585e\u3002MagicTouch AVF \u88ab\u63d0\u8b70\u7528\u65bc\u8655\u7406\u52d5\u975c\u8108\u763b\u7ba1\u7684\u72f9\u7a84\u75c5\u8b8a\uff0c\u5176\u63d0\u4f9b\u4e86\u4e00\u7a2e\u65b0\u65b9\u6cd5\uff0c\u6709\u671b\u6539\u5584\u814e\u8870\u7aed\u60a3\u8005\u7dad\u6301\u751f\u547d\u7684\u6240\u9700\u7684\u8840\u6db2\u900f\u6790\u7642\u6cd5\u7684\u7642\u6548\u3002\u9019\u9805\u6700\u65b0\u6838\u51c6\u5f37\u8abf\u4e86\u00a0Concept Medical \u5728\u7ba1\u7406\u72f9\u7a84\u52d5\u8108\u75c5\u8b8a\u65b9\u9762\u8ffd\u6c42\u5353\u8d8a\u548c\u5275\u65b0\uff0c\u4ee5\u6539\u5584\u75c5\u60a3\u7167\u8b77\u548c\u751f\u6d3b\u54c1\u8cea\u7684\u627f\u8afe\u3002 Concept Medical \u5275\u8fa6\u4eba Manish Doshi \u535a\u58eb\u8868\u793a\uff1a\u300c\u9019\u9805\u6838\u51c6\u4e0d\u50c5\u8b49\u660e\u4e86\u6211\u5011\u5c0d\u5275\u65b0\u7684\u4e0d\u61c8\u8ffd\u6c42\uff0c\u4ea6\u6a19\u8a8c\u8457\u6211\u5011\u91cd\u65b0\u5b9a\u7fa9\u8840\u6db2\u900f\u6790\u60a3\u8005\u6cbb\u7642\u683c\u5c40\u7684\u95dc\u9375\u4e00\u6b65\u3002\u6211\u5011\u671f\u5f85 MagicTouch AVF \u5c0d\u75c5\u60a3\u7167\u8b77\u7522\u751f\u7a4d\u6975\u5f71\u97ff\uff0c\u4e26\u5c0d\u5373\u5c07\u958b\u5c55\u7684\u81e8\u5e8a\u8a66\u9a57\u611f\u5230\u8208\u596e\u3002\u300d Concept Medical \u81f4\u529b\u65bc\u63d0\u51fa\u958b\u5275\u6027\u89e3\u6c7a\u65b9\u6848\uff0c\u6eff\u8db3\u60a3\u8005\u672a\u6eff\u8db3\u7684\u9700\u6c42\u3002\u516c\u53f8\u71b1\u5207\u671f\u5f85\u5728\u4e0b\u500b\u6708\u555f\u52d5 MagicTouch SCB\u00a0\u7684\u00a0AVF IDE \u81e8\u5e8a\u8a66\u9a57\uff0c\u4e26\u6309\u8a08\u5283\u958b\u59cb\u5728\u7f8e\u570b\u70ba\u76ee\u524d\u5df2\u6838\u51c6\u7684\u00a0MagicTouch \u7522\u54c1\u9032\u884c\u5176\u4ed6 IDE \u8a66\u9a57\u7684\u62db\u52df\u5de5\u4f5c\u3002Concept Medical \u5c08\u6ce8\u65bc\u900f\u904e\u5275\u65b0\u63a8\u52d5\u75c5\u60a3\u7167\u8b77\uff0c\u5c07\u7e7c\u7e8c\u81f4\u529b\u65bc\u6539\u5584\u5168\u7403\u75c5\u60a3\u7684\u751f\u6d3b\u3002 \u95dc\u65bc Concept Medical\uff1a Concept Medical \u7e3d\u90e8\u4f4d\u65bc\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e02\uff0c\u696d\u52d9\u904d\u53ca\u5168\u7403\u3002CM \u5c08\u6ce8\u65bc\u958b\u767c\u6cbb\u7642\u8840\u7ba1\u548c\u975e\u8840\u7ba1\u75be\u75c5\u7684\u5275\u65b0\u85e5\u7269\u8f38\u9001\u6280\u8853\uff0c\u5229\u7528\u7368\u7279\u7684\u6280\u8853\u548c\u7522\u54c1\u7d44\u5408\u4ee5\u53ca\u5c08\u6709\u7684\u5857\u5c64\u6280\u8853\uff0c\u5c07\u85e5\u7269\u8f38\u9001\u81f3\u8840\u7ba1\u8154\u9762\u3002 \u5982\u6b32\u9032\u4e00\u6b65\u4e86\u89e3\uff0c\u8acb\u700f\u89bd\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=228873\" \/>\n<meta property=\"og:locale\" content=\"zh_TW\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\" \/>\n<meta property=\"og:description\" content=\"\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e022024\u5e744\u67083\u65e5 \/\u7f8e\u901a\u793e\/ -- Concept Medical \u63a8\u51fa\u7684 MagicTouch AVF\u2014\u2014\u897f\u7f85\u83ab\u65af\u5857\u5c64\u7403\u56ca (DCB) \u5c0e\u7ba1\u2014\u2014\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u7269\u53ca\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u300cIDE \u6838\u51c6\u300d\uff0c\u5176\u5c07\u88ab\u7528\u65bc\u555f\u52d5\u4e00\u9805\u81e8\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1\u72f9\u7a84\u75c5\u8b8a\u3002      US FDA IDE approval to initiate clinical study of Concept Medical&#039;s MagicTouch AVF, a Sirolimus drug-coated balloon (DCB) catheter, for managing stenotic lesions of Arteriovenous Fistula in Chronic Renal Failure.  Concept Medical\u00a0\u662f\u5275\u65b0\u91ab\u7642\u5668\u6750\u6280\u8853\u7684\u9818\u5148\u4f01\u696d\uff0c\u5ba3\u4f48\u5176 MagicTouch AVF\u00a0\u7372\u5f97\u7f8e\u570b\u00a0FDA\u00a0\u7a81\u7834\u6027\u8a8d\u5b9a\u7684\u7814\u7a76\u578b\u5668\u68b0\u8c41\u514d\u00a0(IDE) \u6838\u51c6\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1 (AVF) \u72f9\u7a84\u75c5\u8b8a\u3002 \u516c\u53f8\u7684\u00a0MagicTouch \u7522\u54c1\u7d44\u5408\u5148\u524d\u5df2\u7372\u5f97\u7f8e\u570b\u00a0FDA \u7684\u5176\u4ed6\u56db\u9805\u00a0IDE \u6838\u51c6\uff0c\u7528\u65bc\u4e0d\u540c\u7684\u9069\u61c9\u75c7\u3002AVF \u9069\u61c9\u75c7\u7684\u6700\u65b0\u00a0IDE \u6838\u51c6\u662f\u516c\u53f8\u9023\u7e8c\u7372\u5f97\u7684\u7b2c 5 \u500b\u00a0IDE \u6838\u51c6\u3002 \u7f8e\u570b\u00a0FDA \u7684\u8a72\u9805 IDE \u6838\u51c6\u8b93\u00a0Concept Medical \u80fd\u958b\u5c55\u95dc\u9375\u6027\u81e8\u5e8a\u7814\u7a76\uff0c\u6536\u96c6 MagicTouch \u897f\u7f85\u83ab\u53f8\u5857\u5c64\u7403\u56ca\u5c0e\u7ba1\u5728\u52d5\u975c\u8108\u763b\u7ba1\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8cc7\u6599\uff0c\u70ba\u5c07\u4f86\u5728\u7f8e\u570b\u7684\u4e0a\u5e02\u524d\u6838\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u63f4\u3002 \u6162\u6027\u814e\u8870\u7aed\u60a3\u8005\u9700\u8981\u9032\u884c\u591a\u6b21\u8840\u6db2\u900f\u6790\u6cbb\u7642\uff0c\u9019\u5f80\u5f80\u6703\u5c0e\u81f4\u7528\u65bc\u6cbb\u7642\u7684\u52d5\u975c\u8108\u763b\u7ba1\u53cd\u8986\u963b\u585e\u3002MagicTouch AVF \u88ab\u63d0\u8b70\u7528\u65bc\u8655\u7406\u52d5\u975c\u8108\u763b\u7ba1\u7684\u72f9\u7a84\u75c5\u8b8a\uff0c\u5176\u63d0\u4f9b\u4e86\u4e00\u7a2e\u65b0\u65b9\u6cd5\uff0c\u6709\u671b\u6539\u5584\u814e\u8870\u7aed\u60a3\u8005\u7dad\u6301\u751f\u547d\u7684\u6240\u9700\u7684\u8840\u6db2\u900f\u6790\u7642\u6cd5\u7684\u7642\u6548\u3002\u9019\u9805\u6700\u65b0\u6838\u51c6\u5f37\u8abf\u4e86\u00a0Concept Medical \u5728\u7ba1\u7406\u72f9\u7a84\u52d5\u8108\u75c5\u8b8a\u65b9\u9762\u8ffd\u6c42\u5353\u8d8a\u548c\u5275\u65b0\uff0c\u4ee5\u6539\u5584\u75c5\u60a3\u7167\u8b77\u548c\u751f\u6d3b\u54c1\u8cea\u7684\u627f\u8afe\u3002 Concept Medical \u5275\u8fa6\u4eba Manish Doshi \u535a\u58eb\u8868\u793a\uff1a\u300c\u9019\u9805\u6838\u51c6\u4e0d\u50c5\u8b49\u660e\u4e86\u6211\u5011\u5c0d\u5275\u65b0\u7684\u4e0d\u61c8\u8ffd\u6c42\uff0c\u4ea6\u6a19\u8a8c\u8457\u6211\u5011\u91cd\u65b0\u5b9a\u7fa9\u8840\u6db2\u900f\u6790\u60a3\u8005\u6cbb\u7642\u683c\u5c40\u7684\u95dc\u9375\u4e00\u6b65\u3002\u6211\u5011\u671f\u5f85 MagicTouch AVF \u5c0d\u75c5\u60a3\u7167\u8b77\u7522\u751f\u7a4d\u6975\u5f71\u97ff\uff0c\u4e26\u5c0d\u5373\u5c07\u958b\u5c55\u7684\u81e8\u5e8a\u8a66\u9a57\u611f\u5230\u8208\u596e\u3002\u300d Concept Medical \u81f4\u529b\u65bc\u63d0\u51fa\u958b\u5275\u6027\u89e3\u6c7a\u65b9\u6848\uff0c\u6eff\u8db3\u60a3\u8005\u672a\u6eff\u8db3\u7684\u9700\u6c42\u3002\u516c\u53f8\u71b1\u5207\u671f\u5f85\u5728\u4e0b\u500b\u6708\u555f\u52d5 MagicTouch SCB\u00a0\u7684\u00a0AVF IDE \u81e8\u5e8a\u8a66\u9a57\uff0c\u4e26\u6309\u8a08\u5283\u958b\u59cb\u5728\u7f8e\u570b\u70ba\u76ee\u524d\u5df2\u6838\u51c6\u7684\u00a0MagicTouch \u7522\u54c1\u9032\u884c\u5176\u4ed6 IDE \u8a66\u9a57\u7684\u62db\u52df\u5de5\u4f5c\u3002Concept Medical \u5c08\u6ce8\u65bc\u900f\u904e\u5275\u65b0\u63a8\u52d5\u75c5\u60a3\u7167\u8b77\uff0c\u5c07\u7e7c\u7e8c\u81f4\u529b\u65bc\u6539\u5584\u5168\u7403\u75c5\u60a3\u7684\u751f\u6d3b\u3002 \u95dc\u65bc Concept Medical\uff1a Concept Medical \u7e3d\u90e8\u4f4d\u65bc\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e02\uff0c\u696d\u52d9\u904d\u53ca\u5168\u7403\u3002CM \u5c08\u6ce8\u65bc\u958b\u767c\u6cbb\u7642\u8840\u7ba1\u548c\u975e\u8840\u7ba1\u75be\u75c5\u7684\u5275\u65b0\u85e5\u7269\u8f38\u9001\u6280\u8853\uff0c\u5229\u7528\u7368\u7279\u7684\u6280\u8853\u548c\u7522\u54c1\u7d44\u5408\u4ee5\u53ca\u5c08\u6709\u7684\u5857\u5c64\u6280\u8853\uff0c\u5c07\u85e5\u7269\u8f38\u9001\u81f3\u8840\u7ba1\u8154\u9762\u3002 \u5982\u6b32\u9032\u4e00\u6b65\u4e86\u89e3\uff0c\u8acb\u700f\u89bd\u00a0\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pingtungtimes.com.tw\/?p=228873\" \/>\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=\"2024-04-03T10:20:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2024\/04\/Concept_Medical_US_FDA_approval.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"400\" \/>\n\t<meta property=\"og:image:height\" content=\"225\" \/>\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=228873#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873\"},\"author\":{\"name\":\"\u7f8e\u901a\u793e\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\"},\"headline\":\"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6\",\"datePublished\":\"2024-04-03T10:20:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873\"},\"wordCount\":93,\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/Concept_Medical_US_FDA_approval.jpg\",\"articleSection\":[\"\u7f8e\u901a\u793e\"],\"inLanguage\":\"zh-TW\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873\",\"name\":\"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/Concept_Medical_US_FDA_approval.jpg\",\"datePublished\":\"2024-04-03T10:20:00+00:00\",\"description\":\"\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e022024\u5e744\u67083\u65e5 \\\/\u7f8e\u901a\u793e\\\/ -- Concept Medical \u63a8\u51fa\u7684 MagicTouch AVF\u2014\u2014\u897f\u7f85\u83ab\u65af\u5857\u5c64\u7403\u56ca (DCB) \u5c0e\u7ba1\u2014\u2014\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u7269\u53ca\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u300cIDE \u6838\u51c6\u300d\uff0c\u5176\u5c07\u88ab\u7528\u65bc\u555f\u52d5\u4e00\u9805\u81e8\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1\u72f9\u7a84\u75c5\u8b8a\u3002 US FDA IDE approval to initiate clinical study of Concept Medical's MagicTouch AVF, a Sirolimus drug-coated balloon (DCB) catheter, for managing stenotic lesions of Arteriovenous Fistula in Chronic Renal Failure. Concept Medical\u00a0\u662f\u5275\u65b0\u91ab\u7642\u5668\u6750\u6280\u8853\u7684\u9818\u5148\u4f01\u696d\uff0c\u5ba3\u4f48\u5176 MagicTouch AVF\u00a0\u7372\u5f97\u7f8e\u570b\u00a0FDA\u00a0\u7a81\u7834\u6027\u8a8d\u5b9a\u7684\u7814\u7a76\u578b\u5668\u68b0\u8c41\u514d\u00a0(IDE) \u6838\u51c6\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1 (AVF) \u72f9\u7a84\u75c5\u8b8a\u3002 \u516c\u53f8\u7684\u00a0MagicTouch \u7522\u54c1\u7d44\u5408\u5148\u524d\u5df2\u7372\u5f97\u7f8e\u570b\u00a0FDA \u7684\u5176\u4ed6\u56db\u9805\u00a0IDE \u6838\u51c6\uff0c\u7528\u65bc\u4e0d\u540c\u7684\u9069\u61c9\u75c7\u3002AVF \u9069\u61c9\u75c7\u7684\u6700\u65b0\u00a0IDE \u6838\u51c6\u662f\u516c\u53f8\u9023\u7e8c\u7372\u5f97\u7684\u7b2c 5 \u500b\u00a0IDE \u6838\u51c6\u3002 \u7f8e\u570b\u00a0FDA \u7684\u8a72\u9805 IDE \u6838\u51c6\u8b93\u00a0Concept Medical \u80fd\u958b\u5c55\u95dc\u9375\u6027\u81e8\u5e8a\u7814\u7a76\uff0c\u6536\u96c6 MagicTouch \u897f\u7f85\u83ab\u53f8\u5857\u5c64\u7403\u56ca\u5c0e\u7ba1\u5728\u52d5\u975c\u8108\u763b\u7ba1\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8cc7\u6599\uff0c\u70ba\u5c07\u4f86\u5728\u7f8e\u570b\u7684\u4e0a\u5e02\u524d\u6838\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u63f4\u3002 \u6162\u6027\u814e\u8870\u7aed\u60a3\u8005\u9700\u8981\u9032\u884c\u591a\u6b21\u8840\u6db2\u900f\u6790\u6cbb\u7642\uff0c\u9019\u5f80\u5f80\u6703\u5c0e\u81f4\u7528\u65bc\u6cbb\u7642\u7684\u52d5\u975c\u8108\u763b\u7ba1\u53cd\u8986\u963b\u585e\u3002MagicTouch AVF \u88ab\u63d0\u8b70\u7528\u65bc\u8655\u7406\u52d5\u975c\u8108\u763b\u7ba1\u7684\u72f9\u7a84\u75c5\u8b8a\uff0c\u5176\u63d0\u4f9b\u4e86\u4e00\u7a2e\u65b0\u65b9\u6cd5\uff0c\u6709\u671b\u6539\u5584\u814e\u8870\u7aed\u60a3\u8005\u7dad\u6301\u751f\u547d\u7684\u6240\u9700\u7684\u8840\u6db2\u900f\u6790\u7642\u6cd5\u7684\u7642\u6548\u3002\u9019\u9805\u6700\u65b0\u6838\u51c6\u5f37\u8abf\u4e86\u00a0Concept Medical \u5728\u7ba1\u7406\u72f9\u7a84\u52d5\u8108\u75c5\u8b8a\u65b9\u9762\u8ffd\u6c42\u5353\u8d8a\u548c\u5275\u65b0\uff0c\u4ee5\u6539\u5584\u75c5\u60a3\u7167\u8b77\u548c\u751f\u6d3b\u54c1\u8cea\u7684\u627f\u8afe\u3002 Concept Medical \u5275\u8fa6\u4eba Manish Doshi \u535a\u58eb\u8868\u793a\uff1a\u300c\u9019\u9805\u6838\u51c6\u4e0d\u50c5\u8b49\u660e\u4e86\u6211\u5011\u5c0d\u5275\u65b0\u7684\u4e0d\u61c8\u8ffd\u6c42\uff0c\u4ea6\u6a19\u8a8c\u8457\u6211\u5011\u91cd\u65b0\u5b9a\u7fa9\u8840\u6db2\u900f\u6790\u60a3\u8005\u6cbb\u7642\u683c\u5c40\u7684\u95dc\u9375\u4e00\u6b65\u3002\u6211\u5011\u671f\u5f85 MagicTouch AVF \u5c0d\u75c5\u60a3\u7167\u8b77\u7522\u751f\u7a4d\u6975\u5f71\u97ff\uff0c\u4e26\u5c0d\u5373\u5c07\u958b\u5c55\u7684\u81e8\u5e8a\u8a66\u9a57\u611f\u5230\u8208\u596e\u3002\u300d Concept Medical \u81f4\u529b\u65bc\u63d0\u51fa\u958b\u5275\u6027\u89e3\u6c7a\u65b9\u6848\uff0c\u6eff\u8db3\u60a3\u8005\u672a\u6eff\u8db3\u7684\u9700\u6c42\u3002\u516c\u53f8\u71b1\u5207\u671f\u5f85\u5728\u4e0b\u500b\u6708\u555f\u52d5 MagicTouch SCB\u00a0\u7684\u00a0AVF IDE \u81e8\u5e8a\u8a66\u9a57\uff0c\u4e26\u6309\u8a08\u5283\u958b\u59cb\u5728\u7f8e\u570b\u70ba\u76ee\u524d\u5df2\u6838\u51c6\u7684\u00a0MagicTouch \u7522\u54c1\u9032\u884c\u5176\u4ed6 IDE \u8a66\u9a57\u7684\u62db\u52df\u5de5\u4f5c\u3002Concept Medical \u5c08\u6ce8\u65bc\u900f\u904e\u5275\u65b0\u63a8\u52d5\u75c5\u60a3\u7167\u8b77\uff0c\u5c07\u7e7c\u7e8c\u81f4\u529b\u65bc\u6539\u5584\u5168\u7403\u75c5\u60a3\u7684\u751f\u6d3b\u3002 \u95dc\u65bc Concept Medical\uff1a Concept Medical \u7e3d\u90e8\u4f4d\u65bc\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e02\uff0c\u696d\u52d9\u904d\u53ca\u5168\u7403\u3002CM \u5c08\u6ce8\u65bc\u958b\u767c\u6cbb\u7642\u8840\u7ba1\u548c\u975e\u8840\u7ba1\u75be\u75c5\u7684\u5275\u65b0\u85e5\u7269\u8f38\u9001\u6280\u8853\uff0c\u5229\u7528\u7368\u7279\u7684\u6280\u8853\u548c\u7522\u54c1\u7d44\u5408\u4ee5\u53ca\u5c08\u6709\u7684\u5857\u5c64\u6280\u8853\uff0c\u5c07\u85e5\u7269\u8f38\u9001\u81f3\u8840\u7ba1\u8154\u9762\u3002 \u5982\u6b32\u9032\u4e00\u6b65\u4e86\u89e3\uff0c\u8acb\u700f\u89bd\u00a0\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873#breadcrumb\"},\"inLanguage\":\"zh-TW\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873#primaryimage\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/Concept_Medical_US_FDA_approval.jpg\",\"contentUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/Concept_Medical_US_FDA_approval.jpg\",\"width\":400,\"height\":225},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?p=228873#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u9996\u9801\",\"item\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#website\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\",\"name\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"description\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831PingtungTimes\uff0c\u6700\u95dc\u5fc3\u5728\u5730\u7684\u5a92\u9ad4\",\"publisher\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-TW\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#organization\",\"name\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"contentUrl\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/wp-content\\\/uploads\\\/2023\\\/02\\\/logo-150.png\",\"width\":150,\"height\":150,\"caption\":\"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831\"},\"image\":{\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/pingtungnews\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/#\\\/schema\\\/person\\\/683b937f29ec1537972f6c41e22a2cf3\",\"name\":\"\u7f8e\u901a\u793e\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-TW\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g\",\"caption\":\"\u7f8e\u901a\u793e\"},\"url\":\"https:\\\/\\\/pingtungtimes.com.tw\\\/?author=16\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","description":"\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e022024\u5e744\u67083\u65e5 \/\u7f8e\u901a\u793e\/ -- Concept Medical \u63a8\u51fa\u7684 MagicTouch AVF\u2014\u2014\u897f\u7f85\u83ab\u65af\u5857\u5c64\u7403\u56ca (DCB) \u5c0e\u7ba1\u2014\u2014\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u7269\u53ca\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u300cIDE \u6838\u51c6\u300d\uff0c\u5176\u5c07\u88ab\u7528\u65bc\u555f\u52d5\u4e00\u9805\u81e8\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1\u72f9\u7a84\u75c5\u8b8a\u3002      US FDA IDE approval to initiate clinical study of Concept Medical's MagicTouch AVF, a Sirolimus drug-coated balloon (DCB) catheter, for managing stenotic lesions of Arteriovenous Fistula in Chronic Renal Failure.  Concept Medical\u00a0\u662f\u5275\u65b0\u91ab\u7642\u5668\u6750\u6280\u8853\u7684\u9818\u5148\u4f01\u696d\uff0c\u5ba3\u4f48\u5176 MagicTouch AVF\u00a0\u7372\u5f97\u7f8e\u570b\u00a0FDA\u00a0\u7a81\u7834\u6027\u8a8d\u5b9a\u7684\u7814\u7a76\u578b\u5668\u68b0\u8c41\u514d\u00a0(IDE) \u6838\u51c6\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1 (AVF) \u72f9\u7a84\u75c5\u8b8a\u3002 \u516c\u53f8\u7684\u00a0MagicTouch \u7522\u54c1\u7d44\u5408\u5148\u524d\u5df2\u7372\u5f97\u7f8e\u570b\u00a0FDA \u7684\u5176\u4ed6\u56db\u9805\u00a0IDE \u6838\u51c6\uff0c\u7528\u65bc\u4e0d\u540c\u7684\u9069\u61c9\u75c7\u3002AVF \u9069\u61c9\u75c7\u7684\u6700\u65b0\u00a0IDE \u6838\u51c6\u662f\u516c\u53f8\u9023\u7e8c\u7372\u5f97\u7684\u7b2c 5 \u500b\u00a0IDE \u6838\u51c6\u3002 \u7f8e\u570b\u00a0FDA \u7684\u8a72\u9805 IDE \u6838\u51c6\u8b93\u00a0Concept Medical \u80fd\u958b\u5c55\u95dc\u9375\u6027\u81e8\u5e8a\u7814\u7a76\uff0c\u6536\u96c6 MagicTouch \u897f\u7f85\u83ab\u53f8\u5857\u5c64\u7403\u56ca\u5c0e\u7ba1\u5728\u52d5\u975c\u8108\u763b\u7ba1\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8cc7\u6599\uff0c\u70ba\u5c07\u4f86\u5728\u7f8e\u570b\u7684\u4e0a\u5e02\u524d\u6838\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u63f4\u3002 \u6162\u6027\u814e\u8870\u7aed\u60a3\u8005\u9700\u8981\u9032\u884c\u591a\u6b21\u8840\u6db2\u900f\u6790\u6cbb\u7642\uff0c\u9019\u5f80\u5f80\u6703\u5c0e\u81f4\u7528\u65bc\u6cbb\u7642\u7684\u52d5\u975c\u8108\u763b\u7ba1\u53cd\u8986\u963b\u585e\u3002MagicTouch AVF \u88ab\u63d0\u8b70\u7528\u65bc\u8655\u7406\u52d5\u975c\u8108\u763b\u7ba1\u7684\u72f9\u7a84\u75c5\u8b8a\uff0c\u5176\u63d0\u4f9b\u4e86\u4e00\u7a2e\u65b0\u65b9\u6cd5\uff0c\u6709\u671b\u6539\u5584\u814e\u8870\u7aed\u60a3\u8005\u7dad\u6301\u751f\u547d\u7684\u6240\u9700\u7684\u8840\u6db2\u900f\u6790\u7642\u6cd5\u7684\u7642\u6548\u3002\u9019\u9805\u6700\u65b0\u6838\u51c6\u5f37\u8abf\u4e86\u00a0Concept Medical \u5728\u7ba1\u7406\u72f9\u7a84\u52d5\u8108\u75c5\u8b8a\u65b9\u9762\u8ffd\u6c42\u5353\u8d8a\u548c\u5275\u65b0\uff0c\u4ee5\u6539\u5584\u75c5\u60a3\u7167\u8b77\u548c\u751f\u6d3b\u54c1\u8cea\u7684\u627f\u8afe\u3002 Concept Medical \u5275\u8fa6\u4eba Manish Doshi \u535a\u58eb\u8868\u793a\uff1a\u300c\u9019\u9805\u6838\u51c6\u4e0d\u50c5\u8b49\u660e\u4e86\u6211\u5011\u5c0d\u5275\u65b0\u7684\u4e0d\u61c8\u8ffd\u6c42\uff0c\u4ea6\u6a19\u8a8c\u8457\u6211\u5011\u91cd\u65b0\u5b9a\u7fa9\u8840\u6db2\u900f\u6790\u60a3\u8005\u6cbb\u7642\u683c\u5c40\u7684\u95dc\u9375\u4e00\u6b65\u3002\u6211\u5011\u671f\u5f85 MagicTouch AVF \u5c0d\u75c5\u60a3\u7167\u8b77\u7522\u751f\u7a4d\u6975\u5f71\u97ff\uff0c\u4e26\u5c0d\u5373\u5c07\u958b\u5c55\u7684\u81e8\u5e8a\u8a66\u9a57\u611f\u5230\u8208\u596e\u3002\u300d Concept Medical \u81f4\u529b\u65bc\u63d0\u51fa\u958b\u5275\u6027\u89e3\u6c7a\u65b9\u6848\uff0c\u6eff\u8db3\u60a3\u8005\u672a\u6eff\u8db3\u7684\u9700\u6c42\u3002\u516c\u53f8\u71b1\u5207\u671f\u5f85\u5728\u4e0b\u500b\u6708\u555f\u52d5 MagicTouch SCB\u00a0\u7684\u00a0AVF IDE \u81e8\u5e8a\u8a66\u9a57\uff0c\u4e26\u6309\u8a08\u5283\u958b\u59cb\u5728\u7f8e\u570b\u70ba\u76ee\u524d\u5df2\u6838\u51c6\u7684\u00a0MagicTouch \u7522\u54c1\u9032\u884c\u5176\u4ed6 IDE \u8a66\u9a57\u7684\u62db\u52df\u5de5\u4f5c\u3002Concept Medical \u5c08\u6ce8\u65bc\u900f\u904e\u5275\u65b0\u63a8\u52d5\u75c5\u60a3\u7167\u8b77\uff0c\u5c07\u7e7c\u7e8c\u81f4\u529b\u65bc\u6539\u5584\u5168\u7403\u75c5\u60a3\u7684\u751f\u6d3b\u3002 \u95dc\u65bc Concept Medical\uff1a Concept Medical \u7e3d\u90e8\u4f4d\u65bc\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e02\uff0c\u696d\u52d9\u904d\u53ca\u5168\u7403\u3002CM \u5c08\u6ce8\u65bc\u958b\u767c\u6cbb\u7642\u8840\u7ba1\u548c\u975e\u8840\u7ba1\u75be\u75c5\u7684\u5275\u65b0\u85e5\u7269\u8f38\u9001\u6280\u8853\uff0c\u5229\u7528\u7368\u7279\u7684\u6280\u8853\u548c\u7522\u54c1\u7d44\u5408\u4ee5\u53ca\u5c08\u6709\u7684\u5857\u5c64\u6280\u8853\uff0c\u5c07\u85e5\u7269\u8f38\u9001\u81f3\u8840\u7ba1\u8154\u9762\u3002 \u5982\u6b32\u9032\u4e00\u6b65\u4e86\u89e3\uff0c\u8acb\u700f\u89bd\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=228873","og_locale":"zh_TW","og_type":"article","og_title":"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","og_description":"\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e022024\u5e744\u67083\u65e5 \/\u7f8e\u901a\u793e\/ -- Concept Medical \u63a8\u51fa\u7684 MagicTouch AVF\u2014\u2014\u897f\u7f85\u83ab\u65af\u5857\u5c64\u7403\u56ca (DCB) \u5c0e\u7ba1\u2014\u2014\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u7269\u53ca\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u300cIDE \u6838\u51c6\u300d\uff0c\u5176\u5c07\u88ab\u7528\u65bc\u555f\u52d5\u4e00\u9805\u81e8\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1\u72f9\u7a84\u75c5\u8b8a\u3002      US FDA IDE approval to initiate clinical study of Concept Medical's MagicTouch AVF, a Sirolimus drug-coated balloon (DCB) catheter, for managing stenotic lesions of Arteriovenous Fistula in Chronic Renal Failure.  Concept Medical\u00a0\u662f\u5275\u65b0\u91ab\u7642\u5668\u6750\u6280\u8853\u7684\u9818\u5148\u4f01\u696d\uff0c\u5ba3\u4f48\u5176 MagicTouch AVF\u00a0\u7372\u5f97\u7f8e\u570b\u00a0FDA\u00a0\u7a81\u7834\u6027\u8a8d\u5b9a\u7684\u7814\u7a76\u578b\u5668\u68b0\u8c41\u514d\u00a0(IDE) \u6838\u51c6\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1 (AVF) \u72f9\u7a84\u75c5\u8b8a\u3002 \u516c\u53f8\u7684\u00a0MagicTouch \u7522\u54c1\u7d44\u5408\u5148\u524d\u5df2\u7372\u5f97\u7f8e\u570b\u00a0FDA \u7684\u5176\u4ed6\u56db\u9805\u00a0IDE \u6838\u51c6\uff0c\u7528\u65bc\u4e0d\u540c\u7684\u9069\u61c9\u75c7\u3002AVF \u9069\u61c9\u75c7\u7684\u6700\u65b0\u00a0IDE \u6838\u51c6\u662f\u516c\u53f8\u9023\u7e8c\u7372\u5f97\u7684\u7b2c 5 \u500b\u00a0IDE \u6838\u51c6\u3002 \u7f8e\u570b\u00a0FDA \u7684\u8a72\u9805 IDE \u6838\u51c6\u8b93\u00a0Concept Medical \u80fd\u958b\u5c55\u95dc\u9375\u6027\u81e8\u5e8a\u7814\u7a76\uff0c\u6536\u96c6 MagicTouch \u897f\u7f85\u83ab\u53f8\u5857\u5c64\u7403\u56ca\u5c0e\u7ba1\u5728\u52d5\u975c\u8108\u763b\u7ba1\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8cc7\u6599\uff0c\u70ba\u5c07\u4f86\u5728\u7f8e\u570b\u7684\u4e0a\u5e02\u524d\u6838\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u63f4\u3002 \u6162\u6027\u814e\u8870\u7aed\u60a3\u8005\u9700\u8981\u9032\u884c\u591a\u6b21\u8840\u6db2\u900f\u6790\u6cbb\u7642\uff0c\u9019\u5f80\u5f80\u6703\u5c0e\u81f4\u7528\u65bc\u6cbb\u7642\u7684\u52d5\u975c\u8108\u763b\u7ba1\u53cd\u8986\u963b\u585e\u3002MagicTouch AVF \u88ab\u63d0\u8b70\u7528\u65bc\u8655\u7406\u52d5\u975c\u8108\u763b\u7ba1\u7684\u72f9\u7a84\u75c5\u8b8a\uff0c\u5176\u63d0\u4f9b\u4e86\u4e00\u7a2e\u65b0\u65b9\u6cd5\uff0c\u6709\u671b\u6539\u5584\u814e\u8870\u7aed\u60a3\u8005\u7dad\u6301\u751f\u547d\u7684\u6240\u9700\u7684\u8840\u6db2\u900f\u6790\u7642\u6cd5\u7684\u7642\u6548\u3002\u9019\u9805\u6700\u65b0\u6838\u51c6\u5f37\u8abf\u4e86\u00a0Concept Medical \u5728\u7ba1\u7406\u72f9\u7a84\u52d5\u8108\u75c5\u8b8a\u65b9\u9762\u8ffd\u6c42\u5353\u8d8a\u548c\u5275\u65b0\uff0c\u4ee5\u6539\u5584\u75c5\u60a3\u7167\u8b77\u548c\u751f\u6d3b\u54c1\u8cea\u7684\u627f\u8afe\u3002 Concept Medical \u5275\u8fa6\u4eba Manish Doshi \u535a\u58eb\u8868\u793a\uff1a\u300c\u9019\u9805\u6838\u51c6\u4e0d\u50c5\u8b49\u660e\u4e86\u6211\u5011\u5c0d\u5275\u65b0\u7684\u4e0d\u61c8\u8ffd\u6c42\uff0c\u4ea6\u6a19\u8a8c\u8457\u6211\u5011\u91cd\u65b0\u5b9a\u7fa9\u8840\u6db2\u900f\u6790\u60a3\u8005\u6cbb\u7642\u683c\u5c40\u7684\u95dc\u9375\u4e00\u6b65\u3002\u6211\u5011\u671f\u5f85 MagicTouch AVF \u5c0d\u75c5\u60a3\u7167\u8b77\u7522\u751f\u7a4d\u6975\u5f71\u97ff\uff0c\u4e26\u5c0d\u5373\u5c07\u958b\u5c55\u7684\u81e8\u5e8a\u8a66\u9a57\u611f\u5230\u8208\u596e\u3002\u300d Concept Medical \u81f4\u529b\u65bc\u63d0\u51fa\u958b\u5275\u6027\u89e3\u6c7a\u65b9\u6848\uff0c\u6eff\u8db3\u60a3\u8005\u672a\u6eff\u8db3\u7684\u9700\u6c42\u3002\u516c\u53f8\u71b1\u5207\u671f\u5f85\u5728\u4e0b\u500b\u6708\u555f\u52d5 MagicTouch SCB\u00a0\u7684\u00a0AVF IDE \u81e8\u5e8a\u8a66\u9a57\uff0c\u4e26\u6309\u8a08\u5283\u958b\u59cb\u5728\u7f8e\u570b\u70ba\u76ee\u524d\u5df2\u6838\u51c6\u7684\u00a0MagicTouch \u7522\u54c1\u9032\u884c\u5176\u4ed6 IDE \u8a66\u9a57\u7684\u62db\u52df\u5de5\u4f5c\u3002Concept Medical \u5c08\u6ce8\u65bc\u900f\u904e\u5275\u65b0\u63a8\u52d5\u75c5\u60a3\u7167\u8b77\uff0c\u5c07\u7e7c\u7e8c\u81f4\u529b\u65bc\u6539\u5584\u5168\u7403\u75c5\u60a3\u7684\u751f\u6d3b\u3002 \u95dc\u65bc Concept Medical\uff1a Concept Medical \u7e3d\u90e8\u4f4d\u65bc\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e02\uff0c\u696d\u52d9\u904d\u53ca\u5168\u7403\u3002CM \u5c08\u6ce8\u65bc\u958b\u767c\u6cbb\u7642\u8840\u7ba1\u548c\u975e\u8840\u7ba1\u75be\u75c5\u7684\u5275\u65b0\u85e5\u7269\u8f38\u9001\u6280\u8853\uff0c\u5229\u7528\u7368\u7279\u7684\u6280\u8853\u548c\u7522\u54c1\u7d44\u5408\u4ee5\u53ca\u5c08\u6709\u7684\u5857\u5c64\u6280\u8853\uff0c\u5c07\u85e5\u7269\u8f38\u9001\u81f3\u8840\u7ba1\u8154\u9762\u3002 \u5982\u6b32\u9032\u4e00\u6b65\u4e86\u89e3\uff0c\u8acb\u700f\u89bd\u00a0","og_url":"https:\/\/pingtungtimes.com.tw\/?p=228873","og_site_name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","article_publisher":"https:\/\/www.facebook.com\/pingtungnews","article_published_time":"2024-04-03T10:20:00+00:00","og_image":[{"width":400,"height":225,"url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2024\/04\/Concept_Medical_US_FDA_approval.jpg","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=228873#article","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=228873"},"author":{"name":"\u7f8e\u901a\u793e","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/person\/683b937f29ec1537972f6c41e22a2cf3"},"headline":"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6","datePublished":"2024-04-03T10:20:00+00:00","mainEntityOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=228873"},"wordCount":93,"publisher":{"@id":"https:\/\/pingtungtimes.com.tw\/#organization"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=228873#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2024\/04\/Concept_Medical_US_FDA_approval.jpg","articleSection":["\u7f8e\u901a\u793e"],"inLanguage":"zh-TW"},{"@type":"WebPage","@id":"https:\/\/pingtungtimes.com.tw\/?p=228873","url":"https:\/\/pingtungtimes.com.tw\/?p=228873","name":"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6 - \u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","isPartOf":{"@id":"https:\/\/pingtungtimes.com.tw\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=228873#primaryimage"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=228873#primaryimage"},"thumbnailUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2024\/04\/Concept_Medical_US_FDA_approval.jpg","datePublished":"2024-04-03T10:20:00+00:00","description":"\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e022024\u5e744\u67083\u65e5 \/\u7f8e\u901a\u793e\/ -- Concept Medical \u63a8\u51fa\u7684 MagicTouch AVF\u2014\u2014\u897f\u7f85\u83ab\u65af\u5857\u5c64\u7403\u56ca (DCB) \u5c0e\u7ba1\u2014\u2014\u5df2\u7372\u5f97\u7f8e\u570b\u98df\u7269\u53ca\u85e5\u7269\u76e3\u7763\u7ba1\u7406\u5c40 (FDA) \u7684\u300cIDE \u6838\u51c6\u300d\uff0c\u5176\u5c07\u88ab\u7528\u65bc\u555f\u52d5\u4e00\u9805\u81e8\u5e8a\u7814\u7a76\uff0c\u65e8\u5728\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1\u72f9\u7a84\u75c5\u8b8a\u3002 US FDA IDE approval to initiate clinical study of Concept Medical's MagicTouch AVF, a Sirolimus drug-coated balloon (DCB) catheter, for managing stenotic lesions of Arteriovenous Fistula in Chronic Renal Failure. Concept Medical\u00a0\u662f\u5275\u65b0\u91ab\u7642\u5668\u6750\u6280\u8853\u7684\u9818\u5148\u4f01\u696d\uff0c\u5ba3\u4f48\u5176 MagicTouch AVF\u00a0\u7372\u5f97\u7f8e\u570b\u00a0FDA\u00a0\u7a81\u7834\u6027\u8a8d\u5b9a\u7684\u7814\u7a76\u578b\u5668\u68b0\u8c41\u514d\u00a0(IDE) \u6838\u51c6\uff0c\u53ef\u7528\u65bc\u6cbb\u7642\u6162\u6027\u814e\u8870\u7aed\u8840\u6db2\u900f\u6790\u7ba1\u7406\u4e2d\u7684\u52d5\u975c\u8108\u763b\u7ba1 (AVF) \u72f9\u7a84\u75c5\u8b8a\u3002 \u516c\u53f8\u7684\u00a0MagicTouch \u7522\u54c1\u7d44\u5408\u5148\u524d\u5df2\u7372\u5f97\u7f8e\u570b\u00a0FDA \u7684\u5176\u4ed6\u56db\u9805\u00a0IDE \u6838\u51c6\uff0c\u7528\u65bc\u4e0d\u540c\u7684\u9069\u61c9\u75c7\u3002AVF \u9069\u61c9\u75c7\u7684\u6700\u65b0\u00a0IDE \u6838\u51c6\u662f\u516c\u53f8\u9023\u7e8c\u7372\u5f97\u7684\u7b2c 5 \u500b\u00a0IDE \u6838\u51c6\u3002 \u7f8e\u570b\u00a0FDA \u7684\u8a72\u9805 IDE \u6838\u51c6\u8b93\u00a0Concept Medical \u80fd\u958b\u5c55\u95dc\u9375\u6027\u81e8\u5e8a\u7814\u7a76\uff0c\u6536\u96c6 MagicTouch \u897f\u7f85\u83ab\u53f8\u5857\u5c64\u7403\u56ca\u5c0e\u7ba1\u5728\u52d5\u975c\u8108\u763b\u7ba1\u4e2d\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u8cc7\u6599\uff0c\u70ba\u5c07\u4f86\u5728\u7f8e\u570b\u7684\u4e0a\u5e02\u524d\u6838\u51c6 (PMA) \u7533\u8acb\u63d0\u4f9b\u652f\u63f4\u3002 \u6162\u6027\u814e\u8870\u7aed\u60a3\u8005\u9700\u8981\u9032\u884c\u591a\u6b21\u8840\u6db2\u900f\u6790\u6cbb\u7642\uff0c\u9019\u5f80\u5f80\u6703\u5c0e\u81f4\u7528\u65bc\u6cbb\u7642\u7684\u52d5\u975c\u8108\u763b\u7ba1\u53cd\u8986\u963b\u585e\u3002MagicTouch AVF \u88ab\u63d0\u8b70\u7528\u65bc\u8655\u7406\u52d5\u975c\u8108\u763b\u7ba1\u7684\u72f9\u7a84\u75c5\u8b8a\uff0c\u5176\u63d0\u4f9b\u4e86\u4e00\u7a2e\u65b0\u65b9\u6cd5\uff0c\u6709\u671b\u6539\u5584\u814e\u8870\u7aed\u60a3\u8005\u7dad\u6301\u751f\u547d\u7684\u6240\u9700\u7684\u8840\u6db2\u900f\u6790\u7642\u6cd5\u7684\u7642\u6548\u3002\u9019\u9805\u6700\u65b0\u6838\u51c6\u5f37\u8abf\u4e86\u00a0Concept Medical \u5728\u7ba1\u7406\u72f9\u7a84\u52d5\u8108\u75c5\u8b8a\u65b9\u9762\u8ffd\u6c42\u5353\u8d8a\u548c\u5275\u65b0\uff0c\u4ee5\u6539\u5584\u75c5\u60a3\u7167\u8b77\u548c\u751f\u6d3b\u54c1\u8cea\u7684\u627f\u8afe\u3002 Concept Medical \u5275\u8fa6\u4eba Manish Doshi \u535a\u58eb\u8868\u793a\uff1a\u300c\u9019\u9805\u6838\u51c6\u4e0d\u50c5\u8b49\u660e\u4e86\u6211\u5011\u5c0d\u5275\u65b0\u7684\u4e0d\u61c8\u8ffd\u6c42\uff0c\u4ea6\u6a19\u8a8c\u8457\u6211\u5011\u91cd\u65b0\u5b9a\u7fa9\u8840\u6db2\u900f\u6790\u60a3\u8005\u6cbb\u7642\u683c\u5c40\u7684\u95dc\u9375\u4e00\u6b65\u3002\u6211\u5011\u671f\u5f85 MagicTouch AVF \u5c0d\u75c5\u60a3\u7167\u8b77\u7522\u751f\u7a4d\u6975\u5f71\u97ff\uff0c\u4e26\u5c0d\u5373\u5c07\u958b\u5c55\u7684\u81e8\u5e8a\u8a66\u9a57\u611f\u5230\u8208\u596e\u3002\u300d Concept Medical \u81f4\u529b\u65bc\u63d0\u51fa\u958b\u5275\u6027\u89e3\u6c7a\u65b9\u6848\uff0c\u6eff\u8db3\u60a3\u8005\u672a\u6eff\u8db3\u7684\u9700\u6c42\u3002\u516c\u53f8\u71b1\u5207\u671f\u5f85\u5728\u4e0b\u500b\u6708\u555f\u52d5 MagicTouch SCB\u00a0\u7684\u00a0AVF IDE \u81e8\u5e8a\u8a66\u9a57\uff0c\u4e26\u6309\u8a08\u5283\u958b\u59cb\u5728\u7f8e\u570b\u70ba\u76ee\u524d\u5df2\u6838\u51c6\u7684\u00a0MagicTouch \u7522\u54c1\u9032\u884c\u5176\u4ed6 IDE \u8a66\u9a57\u7684\u62db\u52df\u5de5\u4f5c\u3002Concept Medical \u5c08\u6ce8\u65bc\u900f\u904e\u5275\u65b0\u63a8\u52d5\u75c5\u60a3\u7167\u8b77\uff0c\u5c07\u7e7c\u7e8c\u81f4\u529b\u65bc\u6539\u5584\u5168\u7403\u75c5\u60a3\u7684\u751f\u6d3b\u3002 \u95dc\u65bc Concept Medical\uff1a Concept Medical \u7e3d\u90e8\u4f4d\u65bc\u4f5b\u7f85\u91cc\u9054\u5dde\u5766\u5e15\u5e02\uff0c\u696d\u52d9\u904d\u53ca\u5168\u7403\u3002CM \u5c08\u6ce8\u65bc\u958b\u767c\u6cbb\u7642\u8840\u7ba1\u548c\u975e\u8840\u7ba1\u75be\u75c5\u7684\u5275\u65b0\u85e5\u7269\u8f38\u9001\u6280\u8853\uff0c\u5229\u7528\u7368\u7279\u7684\u6280\u8853\u548c\u7522\u54c1\u7d44\u5408\u4ee5\u53ca\u5c08\u6709\u7684\u5857\u5c64\u6280\u8853\uff0c\u5c07\u85e5\u7269\u8f38\u9001\u81f3\u8840\u7ba1\u8154\u9762\u3002 \u5982\u6b32\u9032\u4e00\u6b65\u4e86\u89e3\uff0c\u8acb\u700f\u89bd\u00a0","breadcrumb":{"@id":"https:\/\/pingtungtimes.com.tw\/?p=228873#breadcrumb"},"inLanguage":"zh-TW","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pingtungtimes.com.tw\/?p=228873"]}]},{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/pingtungtimes.com.tw\/?p=228873#primaryimage","url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2024\/04\/Concept_Medical_US_FDA_approval.jpg","contentUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2024\/04\/Concept_Medical_US_FDA_approval.jpg","width":400,"height":225},{"@type":"BreadcrumbList","@id":"https:\/\/pingtungtimes.com.tw\/?p=228873#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u9996\u9801","item":"https:\/\/pingtungtimes.com.tw\/"},{"@type":"ListItem","position":2,"name":"Concept Medical \u5df2\u7372\u7f8e\u570b FDA \u5c0d Magictouch AVF \u9069\u61c9\u75c7\u7684 IDE \u6838\u51c6\uff0c\u9019\u662f Magictouch \u7522\u54c1\u7d44\u5408\u7372\u5f97\u7684\u7b2c\u4e94\u500b\u7f8e\u570b\u81e8\u5e8a\u7814\u7a76\u6838\u51c6"}]},{"@type":"WebSite","@id":"https:\/\/pingtungtimes.com.tw\/#website","url":"https:\/\/pingtungtimes.com.tw\/","name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","description":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831PingtungTimes\uff0c\u6700\u95dc\u5fc3\u5728\u5730\u7684\u5a92\u9ad4","publisher":{"@id":"https:\/\/pingtungtimes.com.tw\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pingtungtimes.com.tw\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-TW"},{"@type":"Organization","@id":"https:\/\/pingtungtimes.com.tw\/#organization","name":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831","url":"https:\/\/pingtungtimes.com.tw\/","logo":{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/logo\/image\/","url":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","contentUrl":"https:\/\/pingtungtimes.com.tw\/wp-content\/uploads\/2023\/02\/logo-150.png","width":150,"height":150,"caption":"\u5c4f\u6771\u6642\u5831\u96fb\u5b50\u5831"},"image":{"@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/pingtungnews"]},{"@type":"Person","@id":"https:\/\/pingtungtimes.com.tw\/#\/schema\/person\/683b937f29ec1537972f6c41e22a2cf3","name":"\u7f8e\u901a\u793e","image":{"@type":"ImageObject","inLanguage":"zh-TW","@id":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/6c21e24ce33ca5d4572e343395adac2bbef44ff7035a74ea2cab2443c7f0a5f3?s=96&d=blank&r=g","caption":"\u7f8e\u901a\u793e"},"url":"https:\/\/pingtungtimes.com.tw\/?author=16"}]}},"_links":{"self":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts\/228873","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=228873"}],"version-history":[{"count":0,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/posts\/228873\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=\/wp\/v2\/media\/228874"}],"wp:attachment":[{"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=228873"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=228873"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pingtungtimes.com.tw\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=228873"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}