Rotation Medical, Inc., a Minnesota medical device company, has received 510(k) clearance from the Food and Drug Administration for its implantable collagen scaffold technology. The firm’s technology is designed for use during arthroscopic and mini-open procedures to help support the clinical management and protection of tendon injuries in cases in which there has been no substantial loss of tendon tissue.
“Our goal is to improve quality of life for the millions of people who suffer from rotator cuff disease by treating patients earlier and potentially preventing the progression of disease, ” said Martha Shadan, Rotation Medical’s president and chief executive officer. “This regulatory clearance enables us to begin to commercialize our bio-inductive scaffold solution, and we expect to launch in the U.S. later this year.”
According to the company’s figures, rotator cuff tears affect more than four million people annually in the U.S. and are the most common source of shoulder pain and disability. Tears that start out small and, over time, often develop into larger, more painful and debilitating tears due to continuing degeneration of the torn tendon.
Leslie S. Matthews, M.D., chief of orthopedic surgery at Union Memorial Hospital in Baltimore, M.D. said, “There is a strong clinical need for a better solution to treat rotator cuff disease as current rotator cuff repair procedures do not generate appreciable improvement in tendon tissue morphology. In fact, a large number of repaired tendons will deteriorate over time and become prone to re-tears. The Rotation Medical collagen scaffold induces new tissue growth at the site of implantation and increases tendon thickness. We believe that a more robust and healthy appearing tendon will result in improved symptoms and less likelihood of re-tear over time.”
Company officials say that they are planning to conduct post market clinical studies to further demonstrate the effectiveness of its collagen scaffold technology.
if help reinforce the repair we all need to try it