Smith+Nephew announced significant clinical evidence and regulatory updates for its REGENETEN Bioinductive Implant, including the first-ever Strong Recommendation from the American Academy of Orthopaedic Surgeons (AAOS) for bioinductive implants in rotator cuff repair and expanded FDA clearance for extra-articular ligament injuries.
AAOS Issues Strong Recommendation for Bioinductive Implants
The AAOS Clinical Practice Guideline on the Management of Rotator Cuff Injuries now includes a Strong Recommendation stating that "the use of bioinductive tendon implants to augment rotator cuff repair, or as an alternative to standard repair, can lead to lower re-tear rates and better patient reported outcomes." This recommendation represents the first time AAOS guidelines have highlighted the value of bioinductive implants in rotator cuff repair, based on independent analysis of randomized controlled trials.
AAOS Clinical Practice Guidelines provide evidence-based recommendations for current orthopaedic diagnostic, treatment, and postoperative procedures, making this endorsement particularly significant for clinical adoption.
Two-Year Trial Data Demonstrates Sustained Benefits
The MALLAMANGUITO randomized controlled trial, led by Dr. Miguel A. Ruiz Ibán and colleagues, reported two-year results showing a sustained 65% relative reduction in re-tear rates when using the REGENETEN Bioinductive Implant to augment repair of full-thickness rotator cuff tears.
Specifically, two-year re-tear rates were 12.3% (7/57) with the REGENETEN Implant compared to 35.1% (20/57) with standard repair (p=0.004). These results build on previously reported one-year data that have already influenced patient access and clinical adoption.
FDA Expands Indication to Extra-articular Ligaments
For the first time, Smith+Nephew received FDA clearance to market the REGENETEN Bioinductive Implant for extra-articular ligament injuries in the United States. This indication expansion offers opportunities to treat more patients with soft tissue injuries throughout the body, initially focusing on hip capsule repair with potential for future expansion to other extra-articular ligament repairs.
Clinical Impact and Market Adoption
Since its introduction in 2014, the REGENETEN Bioinductive Implant has been used in more than 150,000 procedures globally. The collagen-based implant supports the body's natural healing response to facilitate the formation of new tissue to biologically augment repairs and support natural healing processes.
The device addresses a significant clinical need, offering a solution for the more than 1 million people requiring tendon or extra-articular ligament repair annually.
"These significant updates for the REGENETEN Implant are the culmination of many years of hard work from both the Smith+Nephew team and surgeon community," said Scott Schaffner, President Global Sports Medicine at Smith+Nephew. "We are excited about its future potential to treat even more patients who require surgical repair of soft tissue injuries every year."
The REGENETEN Bioinductive Implant is part of Smith+Nephew's comprehensive Advanced Healing Solutions portfolio, which the company describes as redefining biological healing in rotator cuff repair.
