Study to assess the usability, safety and performance of SINEFIX in support of CE Mark submission
ALBSTADT, Germany, Dec. 13, 2023 /PRNewswire/ — Inovedis 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 SINEFIX™ Rotator Cuff Repair System as part of a pre-market clinical study in Tübingen, Germany.
“The 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,” said Philip Kasten, MD, PhD leading specialist in shoulder orthopedics and trauma surgery and lead investigator of the pre-market clinical study. “I believe that SINEFIX 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.”
Inovedis received clearance from the U.S. Food and Drug Administration (FDA) for SINEFIX 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.
“Suture 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,” according to Inventor, and Co-founder of Inovedis, Stefan Welte, MD. “SINEFIX distributes shear stress uniformly to avoid punctual pressure peaks and therefore improve blood circulation and the vitality of the tendon.”
Lukas Flöss, Co-Founder and Chief Executive Officer of Inovedis, said, “Successfully beginning the treatment of patients with the SINEFIX 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.”
Inovedis GmbH is 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. Since its founding in 2019, Inovedis has been developing SINEFIX™ to simplify rotator cuff tear surgery and improve patient outcomes. SINEFIX received FDA clearance in 2023.
SINEFIX is not approved for sale outside the U.S.
Lukas Flöss, Founder and CEO
Phone: +49 (0) 7432 – 13099 20
SOURCE Inovedis GmbH