{"id":420,"date":"2023-07-06T23:28:58","date_gmt":"2023-07-06T23:28:58","guid":{"rendered":"https:\/\/inovedisusdev.wpenginepowered.com\/?p=420"},"modified":"2024-03-11T20:58:48","modified_gmt":"2024-03-11T20:58:48","slug":"sinefix-fda-clearance","status":"publish","type":"post","link":"https:\/\/inovedis.com\/index.php\/2023\/07\/06\/sinefix-fda-clearance\/","title":{"rendered":"Ä¢¹½¶ÌÊÓƵ Receives FDA Clearance of the Ä¢¹½¶ÌÊÓƵ\u2122 Implant System for Rotator Cuff Repair"},"content":{"rendered":"\n[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.23.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;||||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_row _builder_version=&#8221;4.23.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.23.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text _builder_version=&#8221;4.23.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; sticky_enabled=&#8221;0&#8243;]<p><strong>Company to Launch Ä¢¹½¶ÌÊÓƵ in Selected Clinical Sites in 2023<\/strong><\/p>\n<p>ALBSTADT, Germany \u2013 Ä¢¹½¶ÌÊÓƵ GmbH, a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for Ä¢¹½¶ÌÊÓƵ\u2122, a new implant system for the repair of rotator cuff tears.<\/p>\n<p>In the United States, over 1 million rotator cuff surgeries per year are performed. A rotator cuff tear is a common cause of shoulder pain and disability, and surgery typically involves re-attaching the tendon to the head of the humerus (upper arm bone). The Ä¢¹½¶ÌÊÓƵ implant system allows refixation of the rotator cuff tendon to bone with a simplified surgical technique that has been optimized for minimally invasive surgery. The technique is easy and quick to learn for the surgeon and aims to significantly reduce time and cost of the procedure.<\/p>\n<p>\u201cCurrent clinical standards rely on anchoring the ruptured tendon onto its anatomical insertion zone, or \u2018footprint,\u2019 upon the humerus using a \u2018knot and anchoring technique\u2019. However, these techniques are complex, time-consuming, require an extensive range of instruments and are quite expensive. Moreover, they mainly focus on improving the mechanical fixation of the tendon-bone interface to the detriment of biological healing,\u201d said <a href=\"https:\/\/www.linkedin.com\/in\/stefan-dr-med-welte-0280a339\/\" target=\"_blank\" rel=\"noopener\">Stefan Welte, MD<\/a>, shoulder surgeon and inventor of Ä¢¹½¶ÌÊÓƵ.<\/p>\n<p>Unlike the traditional surgery, the new technique shall both provide effective mechanical reinforcement of the fixed tendon and stimulate the patient&#8217;s intrinsic healing potential. Ä¢¹½¶ÌÊÓƵ is a simple staple implant, which creates a flat and even contact of tendon and bone. It distributes the shear stress uniformly and does not cause punctual pressure peaks, while also maintaining blood circulation and supporting the healing process.<\/p>\n<p>The insertion of the implant is possible with a simple, easy-to-learn two-step technique: The base plate is positioned, and the fixation points are driven into the bone with a hammer and the appropriate Ä¢¹½¶ÌÊÓƵ instruments provided by Ä¢¹½¶ÌÊÓƵ. No preliminary work is needed, and the device may be implanted using arthroscopic techniques or open reconstruction. This simplified technique is designed to reduce the risk of complications due to surgical errors and significantly shortens surgery time, contributing to time and cost savings in clinical surgeries.<\/p>\n<p>\u201cWith FDA clearance we will now initiate a first mover application to generate real-world experience in the U.S. to evaluate the potential of the technology,\u201d says <a href=\"https:\/\/www.linkedin.com\/in\/lukas-fl\u00f6\u00df-1a632486\/\" target=\"_blank\" rel=\"noopener\">Lukas Fl\u00f6ss<\/a>, Founder and CEO. \u201cWe are looking forward to the launch of Ä¢¹½¶ÌÊÓƵ at the upcoming American Orthopaedic Society for Sports Medicine (AOSSM) annual meeting July 13-16th in Washington DC, followed by enrolling clinical sites into our limited market release to begin gathering experience around Ä¢¹½¶ÌÊÓƵ.\u201d<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]\n","protected":false},"excerpt":{"rendered":"<p>Ä¢¹½¶ÌÊÓƵ has received clearance from the U.S. Food and Drug Administration (FDA) for Ä¢¹½¶ÌÊÓƵ, a new implant system for the repair of rotator cuff tears.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<!-- wp:divi\/placeholder \/-->","_et_gb_content_width":"","footnotes":""},"categories":[6],"tags":[],"class_list":["post-420","post","type-post","status-publish","format-standard","hentry","category-press-release"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ä¢¹½¶ÌÊÓƵ Implant System - Ä¢¹½¶ÌÊÓƵ<\/title>\n<meta name=\"description\" content=\"Ä¢¹½¶ÌÊÓƵ receives FDA clearance of the Ä¢¹½¶ÌÊÓƵ Implant System for rotator cuff repair. 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