Rotation Medical Receives 510(k) Clearance for Bioinductive Implant Technology for Treating Rotator Cuff Disease
Plymouth, MN –April 1, 2014 –Rotation Medical, Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its bioinductive implant 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 U.S. 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 preventing the progression of disease,” said Martha Shadan, president and CEO of Rotation Medical. “This regulatory clearance enables us to begin to commercialize our suite of implantable rotator cuff solutions, 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 bioinductive implant 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 Bioinductive Implant 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."
About Rotation Medical
Rotation Medical was founded in 2009 and is committed to advancing the treatment of rotator cuff disease through the development of a proprietary, minimally invasive rotator cuff implant system. The system combines a bioinductive implant that is affixed to the affected tendon using disposable, arthroscopic instruments that are designed to enable quick, reproducible outcomes during both arthroscopic and mini-open procedures. The bioinductive implant offers a new surgical option to intervene earlier and address the root cause of disease progression by promoting tendon healing in patients with rotator cuff tears. For more information visit www.rotationmedical.com.
* Leslie S. Matthews, MD, is an advisor to Rotation Medical.