A study by Rotation Medical that showed the company’s collagen-based implant stimulates new tissue to form in patients with rotator cuff tears is gaining more traction.
The results of the biopsy study released earlier this year have now been published online in Arthroscopy, the company reported. Earlier this month, the study was published in Muscles, Ligaments and Tendons Journal.
Using a collagen-based bioinductive implant about the size of a nickel, Rotation Medical’s implant is derived from bovine Achilles tendon. The implant is designed to promote the formation of new tendonlike tissue in the rotator cuff and absorb gradually over 6 months, according to the company. The implant, which was cleared by the FDA in 2014, is applied arthroscopically.
“This is a breakthrough study, as it is the first to show that the Rotation Medical bioinductive implant promotes the rapid growth of tendon-like tissue in humans,” Dr. Steven Arnoczky, lead investigator of the study and director of the Laboratory for Comparative Orthopaedic Research at Michigan State University, said in a statement. “The unique opportunity to evaluate biopsies from implant recipients confirms the findings of the preclinical animal study, and demonstrates that the implant is biocompatible and promotes new connective tissue with the histological appearance of tendon over the surface of the native cuff tendon.”
The retrospective study included biopsies from 7 patients who had a second arthroscopic procedure for issues unrelated to the implant at various time points (5 weeks to 6 months) following arthroscopic rotator cuff repair with the bioinductive implant. The biopsy specimens were examined histologically for host-tissue ingrowth, host-tissue maturation and host-implant biocompatibility.
“These biopsies underscore the safety of our Rotation Medical bioinductive implant in humans, as well as its ability to promote new tissue formation in a consistent and predictable manner,” Martha Shadan, president and CEO of Rotation Medical, said in the statement.