Inovedis GmbH Receives FDA Clearance for SINEFIX™ Implant System for Rotator Cuff Repair

Friday, July 07, 2023

Inovedis GmbH, a medical technology start-up dedicated to optimizing patient care and simplifying surgical interventions, has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its SINEFIX™ Implant System. This innovative system is designed for the repair of rotator cuff tears.

Rotator cuff tears are a common cause of shoulder pain and disability, with over one million surgeries performed annually in the United States. Traditional surgical procedures involve reattaching the torn tendon to the upper arm bone (humerus). The SINEFIX Implant System introduces a streamlined surgical technique specifically developed for minimally invasive surgery, aiming to reduce complexity and improve outcomes.

Dr. Stefan Welte, a shoulder surgeon and the inventor of SINEFIX, explained that current clinical standards rely on complex and time-consuming knot and anchoring techniques, requiring a wide range of instruments and incurring high costs. In contrast, the SINEFIX Implant System simplifies the process by providing effective mechanical reinforcement of the fixed tendon while also stimulating the body's natural healing potential. The system utilizes a simple staple implant that creates even contact between the tendon and bone, distributing stress evenly and maintaining blood circulation to support the healing process.

The implantation of the SINEFIX system follows a straightforward two-step technique, making it easy for surgeons to learn. The base plate is positioned, and the fixation points are driven into the bone using the specialized instruments provided by Inovedis. The technique does not require extensive preparatory work and can be performed using arthroscopic or open reconstruction approaches. This simplified procedure reduces the risk of surgical errors and significantly shortens surgery time, leading to potential cost and time savings.

Lukas Flöss, Founder and CEO of Inovedis, expressed enthusiasm about the FDA clearance and the opportunity to gain real-world experience in the United States. The company plans to showcase the SINEFIX Implant System at the upcoming American Orthopaedic Society for Sports Medicine (AOSSM) annual meeting in Washington DC. Following the launch, Inovedis intends to enroll clinical sites in a limited market release to gather valuable feedback and insights.

The FDA clearance of the SINEFIX Implant System represents a significant advancement in rotator cuff repair, offering a simplified surgical technique that aims to improve patient outcomes while minimizing complexity and costs associated with the procedure.




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