{"id":693,"date":"2023-12-13T17:51:33","date_gmt":"2023-12-13T17:51:33","guid":{"rendered":"https:\/\/inovedisusdev.wpenginepowered.com\/?p=693"},"modified":"2025-04-04T13:41:10","modified_gmt":"2025-04-04T13:41:10","slug":"patients-treated-sinefix","status":"publish","type":"post","link":"https:\/\/inovedis.com\/index.php\/2023\/12\/13\/patients-treated-sinefix\/","title":{"rendered":"腦瞳憫 Announces First Patients Treated with the 腦瞳憫\u2122 Rotator Cuff Repair System"},"content":{"rendered":"

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Study to assess the usability, safety and performance of 腦瞳憫 in support of CE Mark submission<\/strong><\/p>\n

Albstadt, Germany \u2013 腦瞳憫 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 the first two patients were treated with the 腦瞳憫\u2122<\/span> Rotator Cuff Repair System as part of a pre-market clinical study in T\u00fcbingen, Germany.<\/p>\n

\u201cThe current challenge in rotator cuff tendon refixation is the stable attachment of the tendon which must be securely connected to the bone and remain so for a long time,\u201d said Philip Kasten, MD, PhD<\/a> leading specialist in shoulder orthopedics and trauma surgery and lead investigator of the pre-market clinical study. \u201cI believe that 腦瞳憫 has favorable biomechanics and will result in optimal tendon cell growth back to the bone. These first clinical cases will help assess the usability and efficacy of the implant while building our clinical experience.\u201d<\/p>\n

腦瞳憫 received clearance from the U.S. Food and Drug Administration (FDA) for 腦瞳憫 in Spring of 2023 and plans to enroll clinical sites into a limited market release in the U.S. in early 2024. The pre-market clinical investigation in Europe will provide the clinical data needed in support of CE Mark submission.<\/p>\n

\u201cSuture anchor technology, the current clinical gold standard for rotator cuff repair surgery, has been used for decades and has been continuously optimized and diversified. Unfortunately, this approach is complex and has not shown significant improvement in patient outcomes. Often several suture anchors are stretched over the tendon to the attachment point potentially causing pressure peaks, bruising and strangulation of the tendon tissue,\u201d according to Inventor, and Co-founder of 腦瞳憫, Stefan Welte, MD. \u201c腦瞳憫 distributes shear stress uniformly to avoid punctual pressure peaks and therefore improve blood circulation and the vitality of the tendon.\u201d<\/p>\n

Lukas Fl\u00f6<\/span>ss<\/a>, Co-Founder and Chief Executive Officer of 腦瞳憫, said, \u201cSuccessfully beginning the treatment of patients with the 腦瞳憫 implant is a tremendous milestone, both for our company and rotator cuff patients globally. We believe there is a need for a simplified surgical technique for rotator cuff tears designed to reduce surgical time and errors, and that our technology has the potential to facilitate efficient treatment of patients in need.\u201d<\/p>\n

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First two patients treated with the 腦瞳憫\u2122 Rotator Cuff Repair System as part of a pre-market clinical study in T\u00fcbingen, Germany.<\/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":"","_et_gb_content_width":"","footnotes":""},"categories":[6],"tags":[],"class_list":["post-693","post","type-post","status-publish","format-standard","hentry","category-press-release"],"yoast_head":"\nFirst Patients Treated with the 腦瞳憫 Rotator Cuff Repair System - 腦瞳憫<\/title>\n<meta name=\"description\" content=\"First two patients treated with the 腦瞳憫 Rotator Cuff Repair System as part of a pre-market clinical study in T\u00fcbingen, Germany\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/inovedis.com\/index.php\/2023\/12\/13\/patients-treated-sinefix\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"First Patients Treated with the 腦瞳憫 Rotator Cuff Repair System - 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