Smith & Nephew (NYSE:SNN) announced today that its Regeneten bioinductive implant for rotator cuff procedures received CE Mark approval in Europe.
Regeneten, a collagen-based implant, 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.
The implant, which is the size of a postage stamp, is delivered arthroscopically through a small incision over the location of the rotator cuff tendon injury and completely resorbed within six months. More than 40,000 procedures with Regeneten have been completed since it was introduced in the U.S., according to a news release.
London-based Smith & Nephew’s implant can be used in procedures ranging from partial-thickness tears to large (3-5 cm) and massive (5 cm and more) thickness tears.
“We are delighted to gain CE Mark for Regeneten and be able to offer up this ground-breaking technology to our customers in Europe,” Smith & Nephew senior marketing director for EMEA Terry Byca said in the release. “The U.S. market has demonstrated over the last five years that Regeneten 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.”