The implant manages compression without overstressing the tendon, maintaining blood flow. Credit: Peter Porrini / Shutterstock.

Medical technology start-up Inovedis has reached a pivotal point with the first US patients treated using its SINEFIX Rotator Cuff Repair System.

Orthopaedic surgeon Dr Brian Cohen was involved in the launch of SINEFIX in the US.

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This development marks a significant shift in rotator cuff surgery, focusing not only on biomechanical fixation but also on the essential role of blood flow in tendon-to-bone healing.

Inovedis co-founder and inventor of the SINEFIX system Dr Stefan Welte said: “Rotator cuff repair surgeries are among the most common soft tissue procedures, with over half a million performed each year in the US alone.

“Unfortunately, traditional methods using suture anchors have not yielded significant improvements in patient recovery. Our vision is to revolutionise biomechanical fixation and enhance biological healing. The success of these first cases in the US brings us closer to that goal.”

Cohen said that the SINEFIX implant manages compression without overstressing the tendon, maintaining blood flow and potentially establishing a new benchmark for rotator cuff repair.

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Designed for up to 2cm tendon ruptures, the system features a simplified process that involves two steps using a PEEK plate and two PEEK anchors, comprising additional teeth for preventing slippage of the tendon.

Additionally, the system removes the need for management of complex sutures.

Inovedis CEO Tom Anstead said: “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 US mark a significant achievement for our team.”

In July 2023, Inovedis received the US Food and Drug Administration approval for SINEFIX for rotator cuff tear repair in which using a simplified surgical technique, the implant system helps refix the rotator cuff tendon to the bone.