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Nearly 500,000 rotator cuff repairs are performed in the U.S. annually, and 20% to 70% of these repairs fail structurally. Inadequate tendon-to-bone ingrowth results in incomplete healing, gap formation, and a high risk of re-tear. Tendon reattachment is a crucial clinical need, especially in larger tears because failure rates increase linearly with tear size.
While most augmentation products have been designed as “overlays” to reinforce the tendon, Tetrous EnFix RC, a procedure-specific implant for rotator cuff repair that is specifically designed to address Enthesis Failure Syndrome, enhances healing at the enthesis where failure often occurs.
Dr. Nikhil Verma, MD, Professor and Director, Division of Sports Medicine and Fellowship Director, Department of Orthopedics, Rush University Medical Center, who performed the first four surgeries with the EnFix RC, says, “I was thrilled to be the first surgeon to deploy the EnFix RC. I used one EnFix RC in each case to augment the medial suture anchor fixation. Initially I was impressed with the concept of flipping the script compared to most of the products today for surgical augmentation. I also was very pleased with how the implant and instrument design was optimized, simplifying the delivery of the product into the interface between the tendon and the bone. The procedure is minimally disruptive to the way rotator cuff surgeries are typically performed. I plan to use the EnFix RC routinely moving forward.”
The EnFix RC rotator cuff implant is made from proprietary demineralized cortical bone fibers. Using Bone Textile™ technology to produce the implant yields long and strong bone fibers that promote cell wicking, cell adhesion, and cell proliferation, while FormLok™ technology imparts shape retention to the device, even when immersed in liquid, as is regularly required for use in arthroscopic surgery.
