510(k) clearance for implantable collagen scaffold

510(k) clearance for implantable collagen scaffold

New technologies to treat rotator cuff disease is designed for use during arthroscopic and mini-open procedures.

April 4, 2014
Manufacturing Group
Contract Manufacturing Industry/Regulations Devices/Implants/Equipment People/Facilities

Plymouth, Minnesota – Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, has received 510(k) clearance from the Food and Drug Administration (FDA) for its implantable collagen scaffold technology. The new technology is 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.

Rotator cuff tears affect more than four million people annually 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.

“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 preventingthe progression of disease,” says Martha Shadan, president and chief executive officer of Rotation Medical. “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.”

The company is also planning to conduct post market clinical studies to further demonstrate the effectiveness of its collagen scaffold technology.

“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,” said Leslie S. Matthews,* MD, chief of orthopedic surgery at Union Memorial Hospital in Baltimore, MD. “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."

Source: Rotation Medical

* Leslie S. Matthews, MD, is an advisor to Rotation Medical.