The device will help to repair rotator cuff tears. Image credit: Axel_Kock via Shutterstock.

Tetrous, a company that specialises in regenerative medicine, has completed the first four surgeries using EnFix RC, a procedure-specific implant for rotator cuff repair, designed to address Enthesis Failure Syndrome. The enthesis is the site where a tendon, ligament, joint capsule, or fascia attaches to the bone.

Rotator cuff repairs are increasing. Between 2007 to 2016, 314,239 rotator cuff repairs were performed in the US. In about 20% of cases, these operations fail structurally.

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Where the tendon does not effectively regrow to the bone there may be incomplete healing, gap formation and a high risk of re-tear. Therefore, reattaching the tendon is crucial, especially in the case of larger tears as failure rates increase with the size of the tear.

Most augmentation products are designed to reinforce the tendon. However, EnFix RC differs as it enhances healing at the enthesis where failure often occurs.

John Bojanowski, Tetrous’ Head of Sales and Marketing said:  “We are proud to offer a highly differentiated clinical solution. EnFix RC specifically promotes the remodelling of tissue approximating that of the natural tendon-bone interface, known as the enthesis. Tendon reattachment to the bone is a crucial clinical need, especially in larger tears, since failure rates increase linearly with tear size.”

The EnFix RC implant is made from demineralised cortical bone fibres. US-based Tetrous’ Bone Textile technology produces long and strong bone fibres to promote cell wicking, adhesion, and proliferation, and its FormLok technology promotes shape retention to the device.

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The news comes just days after a rival company, Inovedis got FDA approval for its rotator cuff repair implant SINEFIX.