TENDON REGENERATION IMPLANT RECEIVES CE MARK
Tendon regeneration is key to a successful rotator cuff repair.
London-based Smith & Nephew, plc’s Regeneten Bioinductive Implant has received CE Mark certification allowing the company to market the implant in post-Brexit European markets. Since its U.S. introduction, the company says more than 40,000 procedures have been completed and “has had a transformative impact on the way surgeons approach rotator cuff procedures.”
The collagen-based implant, the size of a postage stamp, “supports the body’s natural healing process by inducing the growth of new tendon-like tissue to biologically augment the existing tendon and disrupt disease progression.”
Inserted “arthroscopically through a small incision over the location of the rotator cuff tendon injury,” the implant is “completely resorbed within six months,” according to a June 16, 2020 company press release. It “can be used in procedures ranging from partial-thickness tears to large (3-5 cm) and massive (5 cm and more) thickness tears.”
Terry Byca, the company’s senior marketing director, said the U.S. market has demonstrated over the last five years that the implant “is changing surgeons’ traditional approach to rotator cuff repair; biological healing is imperative and our advanced healing shoulder repair products together with Regeneten take us into a new era for joint repair.”
Mr. Chris Peach, Consultant Shoulder and Elbow Surgeon, Orthteam Centre, UK and Chairman of the Research Committee of the British Elbow and Shoulder Society, said the implant is “the most exciting advance in the field of rotator cuff surgery in my career and has the prospect of completely transforming patient outcomes.”
Professor Emilio Calvo, M.D., Ph.D., MBA, Shoulder and Elbow Reconstructive Surgery Unit, Universidad Autónoma, Spain, added, “A biologics solution for a biologic problem; a completely new approach for rotator cuff tear repair and reinforcement that will change patient outcomes.”
According to the company, the implant will be available to use on the 310,000+ rotator cuff procedures performed each year in Europe in a market worth an estimated $175 million annually.