Rotation Medical, which is dedicated to developing technologies to treat rotator cuff disease, reported study results Wednesday showing its collagen-based implant caused new tissue to form in patients with rotator cuff tears.
Rotator cuff tears are traditionally treated with surgery, but given the long rehabilitation time and lifestyle changes required for recovery, many people wait until the injury and pain have progressed before opting for surgery, Rotation said in a statement. According to the Mayo Clinic, some surgical procedures to treat rotator cuff injuries are time-sensitive. Waiting too long can make rotator cuff repair difficult.
Rotation Medical’s rotator cuff system is a collagen-based, bioinductive implant the size of a postage stamp. Derived from bovine Achilles tendon, it is designed to promote the formation of new tendon-like tissue in the rotator cuff and absorb gradually over 6 months, according to the company. It is delivered arthroscopically and was FDA-cleared in 2014.
The study results, published in Muscles, Ligaments and Tendons Journal, showed the implant induced “significant” new tissue formation in all 13 patients three months after treatment, according to the statement. The patients all had partial thickness rotator cuff tears. As time went on, the tissue matured and became “radiologically indistinguishable” from the tendon being treated. Two years after treatment, patient MRIs showed that the tears did not worsen. Partial tears usually enlarge and often advance to full-thickness tears, said Dr. Desmond John Bokor, lead study investigator and associate professor in the Department of Orthopaedic Surgery at Macquarie University in Australia, in the statement.
“The results of this study demonstrate the ability of the bioinductive implant to induce new tendon-like tissue, enabling partial-thickness rotator cuff tears to decrease in size and in most cases disappear,” Bokor said in the statement. “The ability to heal partial-thickness rotator cuff defects, and thus prevent tear propagation and progressive tendon degeneration, represents a novel interventional treatment paradigm for these lesions.”