Rotation Medical has received 510(k) clearance from the Food and Drug Administration (FDA) for its implantable collagen scaffold technology, designed for use during arthroscopic and mini-open procedures to help support clinical management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Every year more than four million people suffer from Rotator cuff tears in the US and are the most common source of shoulder pain and disability.
Tears that start out small, over time, often develop into larger, more painful and debilitating tears due to continuing degeneration of the torn tendon.
Rotation Medical president and CEO Martha Shadan said the company’s 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.
"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," Shadan added.
The company is also planning to conduct post market clinical studies to further demonstrate the effectiveness of its collagen scaffold technology.
Union Memorial Hospital in Baltimore, Maryland chief of orthopedic surgery Dr Leslie Matthews 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," Dr Matthews added.
"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."