{"id":15428,"date":"2023-08-03T12:48:00","date_gmt":"2023-08-03T04:48:00","guid":{"rendered":"https:\/\/flcube.com\/?p=15428"},"modified":"2024-11-29T00:40:54","modified_gmt":"2024-11-28T16:40:54","slug":"suzhou-jiecheng-medical-secures-fda-bdd-for-transvascular-aortic-valve-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15428","title":{"rendered":"Suzhou Jiecheng Medical Secures FDA BDD for Transvascular Aortic Valve Treatment"},"content":{"rendered":"\n<p>Suzhou Jiecheng Medical Technology Co., Ltd has announced that it has obtained Breakthrough Devices Designation (BDD) from the US Food and Drug Administration (FDA) for its proprietary transvascular interventional biological aortic valve. The device is designed for the treatment of severe aortic valve regurgitation (insufficiency) and mixed aortic valve disease with regurgitation, addressing a significant unmet need as there is no interventional aortic valve product approved for marketing in the US.<\/p>\n\n\n\n<p><strong>Advantages of the Transvascular Approach and Clinical Benefits<\/strong><br>The product offers a transvascular (femoral artery) approach, providing more access options for patients. This approach is associated with several advantages, including shorter operation times, reduced surgical trauma, and faster patient recovery. The valve is capable of treating both aortic valve regurgitation and stenosis, with particular efficacy in treating simple non-calcified aortic valve regurgitation, where it offers unique benefits.<\/p>\n\n\n\n<p><strong>Humanitarian Use and Clinical Experience<\/strong><br>The device has already been used to treat over 30 patients in the US and Canada through humanitarian channels, demonstrating its potential impact on patient care and clinical outcomes.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Suzhou Jiecheng Medical Technology Co., Ltd has announced that it has obtained Breakthrough Devices Designation&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,22],"tags":[34,69,2439],"class_list":["post-15428","post","type-post","status-publish","format-standard","hentry","category-company","category-medical-device","tag-breakthrough-therapy","tag-cvd","tag-jiecheng-medical-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Suzhou Jiecheng Medical Secures FDA BDD for Transvascular Aortic Valve Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Suzhou Jiecheng Medical Technology Co., Ltd has announced that it has obtained Breakthrough Devices Designation (BDD) from the US Food and Drug Administration (FDA) for its proprietary transvascular interventional biological aortic valve. The device is designed for the treatment of severe aortic valve regurgitation (insufficiency) and mixed aortic valve disease with regurgitation, addressing a significant unmet need as there is no interventional aortic valve product approved for marketing in the US.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=15428\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Suzhou Jiecheng Medical Secures FDA BDD for Transvascular Aortic Valve Treatment\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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