Smith+Nephew received CE Mark approval for the REGENETEN™ Bioinductive Implant. In the repair of rotator cuff injuries, the collagen-based device induces growth of new tendon-like tissue to augment the existing tendon and disrupt disease progression.
REGENETEN is delivered arthroscopically through a small incision over the location of the injury. The implant is about the size of a postage stamp and is completely resorbed within six months.
Since its U.S. introduction, the device has been used in more than 40,000 procedures addressing partial thickness tears to difficult-to-treat large and massive thickness tears. The implant will be available to use on the 310,000+ rotator cuff procedures that take place each year in Europe.
"We are delighted to gain CE Mark for REGENETEN and be able to offer up this ground-breaking technology to our customers in Europe," said Terry Byca, Senior Director Marketing EMEA, Smith+Nephew. "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."