
Inovedis Announces First Patients Treated With The SINEFIXTM Rotator Cuff Repair System In The U.S.
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 SINEFIXTM. "Despite improved fixation methods, retear rates remain high. The SINEFIXTM implant controls compression without straining the tendon, preserving blood flow and potentially setting a new standard in rotator cuff repair."
The SINEFIXTM 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 SINEFIXTM 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 SINEFIXTM'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 SINEFIXTM 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 SINEFIXTM 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.
To learn more, visit our website and follow us on LinkedIn .
MEDIA CONTACT:
Ronda Taylor
[email protected]
SOURCE Inovedis Inc.
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