Rotation Medical touted data today from the 1st study of its collagen-based bioinductive implant in patients with large and massive rotator cuff tears. The results were presented at the American Academy of Orthopedic Surgeons in San Diego.
The data demonstrated that the company’s implant induced new tissue formation in all 23 participants.
“Failure of large and revision rotator cuff repairs continues to be a challenging problem,” study investigator Dr. Felix Savoie said in prepared remarks. “This study is exciting for the field of rotator cuff repair, as it showed that the Bioinductive Implant induces new tissue formation and assists in healing for patients with large and massive rotator cuff tears.”
More than half of the enrolled patients had previous rotator cuff repairs and all of the participants received the company’s bioinductive implant through arthroscopic surgery.
All but 1 patient successfully healed their rotator cuffs, according to Rotation Medical.
Researchers assessed tendon thickness at 3, 6 and 12 months using postoperative ultrasound. They also took MRIs at 6 and 12 months to confirm healing and tendon thickness. At the most recent follow-up, rotator cuff thickness ranged from 5 to 9 millimeters, the company reported.
“Results of this study are consistent with the biopsy study published last month in Arthroscopy showing that our bioinductive implant promotes the growth of tendon-like tissue,” president & CEO Martha Shadan. “There is a growing body of evidence demonstrating that the Rotation Medical Rotator cuff system has the potential to transform the treatment of rotator cuff disease by addressing both the biomechanics and biology required to heal a rotator cuff tendon tear.”