Rotation Medical today released data from a study of its bioinductive implants, designed as part of a novel rotator cuff repair system, touting the device’s ability to promote new connective tissue.
Data came from a retrospective biopsy study, with results published online in the journal Arthroscopy.
The study aimed to explore the biocompatibility of the device as well as the histological appearance of the tendon where it was implanted, Plymouth, Minn.-based Rotation Medical said.
Biopsies from 7 patients who underwent a 2nd arthroscopic procedure for non-implant related issues were examined histologically for host-tissue ingrowth, host-tissue maturation and host-implant biocompatibility.
Results indicated the presence of fibroblasts within the porous collagen implant interstices at 5 weeks, increased collagen formation, maturation and organization after 3 months and newly generated tissue with the histologic appearance of tendon tissue. No evidence of remnants of the collagen implant were seen at 6 months, Rotation Medical said.
The company said that it found no evidence of any adverse inflammatory or foreign body reactions at any time point during the study.
“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. While clinical studies have demonstrated evidence of new tissue generation via imaging, the histologic character of this tissue could only be inferred. 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,” lead investigator Dr. Steven Arnoczky of Michigan State University said in a prepared statement.
“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. We are encouraged by the results of this study, which provides further evidence that our bioinductive implant can biologically augment torn tendons and potentially reduce re-tear and revision rates,” prez & CEO Martha Shadan said in a press release.
Rotation makes a regenerative treatment for repairing the shoulder’s rotator cuff – a group of muscles and tendons that attach the humerus to the scapula. The system won 510(k) clearance in March 2014.
Earlier this month, Rotation medical released results from a study of its regenerative rotator cuff system, touting significant new tissue formation and no tear progression in patients at 24 months.
The 13-patient study aimed to assess the ability of Rotation Medical’s implant to induce new tissue formation and limit tear progression. Data from the study indicated new tissue formation in all 13 patients at 3 months, with tissue maturing over time and becoming radiologically indistringuishable from the underlying tendon.
Results also indicated no tear progression as observed via MRI in any of the patients during the 24-month post-operative period, and patients reported significant improvements on Constant and American Shoulder and Elbow Society clinical scores.