MINNEAPOLIS, Oct. 24, 2024 - Inovedis Inc., a cutting-edge medical technology start-up, has announced a major milestone in soft tissue repair with the first U.S. patients receiving treatment using their revolutionary SINEFIX™ Rotator Cuff Repair System. This breakthrough system aims to transform the approach to rotator cuff surgery by addressing not just biomechanical fixation, but the critical role of blood flow in tendon-to-bone healing.
Rotator cuff repairs have historically been plagued by high failure rates despite advancements in surgical techniques. Many traditional methods focus on strengthening the fixation of the tendon to the bone, but new findings suggest that overemphasis on fixation might actually hinder the healing process. The key lies in minimizing tension and evenly distributing pressure over the largest possible contact surface between tendon and bone, promoting better circulation and biological healing.
"Rotator cuff surgery requires biomechanical stability, but excessive tension can compromise blood flow and slow healing," explained Dr. Brian Cohen, an orthopedic surgeon involved in the U.S. launch of SINEFIX™. "Despite improved fixation methods, retear rates remain high. The SINEFIX™ implant controls compression without straining the tendon, preserving blood flow and potentially setting a new standard in rotator cuff repair."
The SINEFIX™ system, designed for tendon ruptures up to 2 cm, features a simplified two-step process using a PEEK plate and two PEEK anchors, equipped with additional teeth to prevent tendon slippage. This design keeps the tendon vital by maintaining blood circulation, which is essential for biological healing. The system eliminates the need for complex suture management, making it a more accessible technique for surgeons and improving patient outcomes.
"Rotator cuff repair surgeries are among the most common soft tissue procedures, with over half a million performed each year in the U.S. alone," said Dr. Stefan Welte, co-founder of Inovedis and inventor of the SINEFIX™ system. "Unfortunately, traditional methods using suture anchors have not yielded significant improvements in patient recovery. Our vision is to revolutionize biomechanical fixation and enhance biological healing. The success of these first cases in the U.S. brings us closer to that goal."
Tom Anstead, CEO of Inovedis Inc., emphasized the importance of the technology in reducing surgery time and cost while enhancing patient care. "The simplicity of SINEFIX™'s surgical technique, which eliminates the need for knot tying, is a critical step toward making this groundbreaking technology available to surgeons worldwide. Our first successful cases in the U.S. mark a significant achievement for our team."
As Inovedis continues to pioneer advancements in orthopedic repair, the introduction of SINEFIX™ represents a potential turning point in the treatment of rotator cuff injuries, offering new hope for improved recovery and long-term healing.
ABOUT INOVEDIS
Inovedis 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.
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MEDIA CONTACT:
Ronda Taylor
rtaylor@kalistaylormktg.com
SOURCE Inovedis Inc.
