Rotation Medical touted initial data today from the Rebuild registry of its bioinductive implant at the annual meeting of the Arthroscopy Association of North America.
Interim results from the 1st 200 patients demonstrated significantly less post-operative pain and use of narcotics in patients who received the bioinductive implant, as well as less sling time, faster return to function and better overall shoulder rating.
Patients in the registry reported feeling better 6 months after receiving the implant than those who received traditional treatment did at 2 years. The registry is slated to follow up to 300 patients.
“Patients often opt out or delay surgery in the early stages of rotator cuff disease due to long and painful rehabilitation,” study investigator Dr. Louis McIntyre said in prepared remarks. “Initial results of the Rebuild registry demonstrate statistically significant improvements in several outcomes measures, including pain, function and overall shoulder rating.”
Data from the Rebuild registry are being compared to data in a national orthopedic database using standard rotator cuff treatment, according to the company.
“Payors and providers are increasingly looking for data that demonstrate the effectiveness of medical devices on key health economic drivers,” president & CEO Martha Shadan added. “With the results of the Rebuild registry, we believe our bioinductive implant is well-positioned to transform the treatment of rotator cuff disease, enabling patients to get back to work and other activities more quickly with less pain and use of narcotics than traditional rotator cuff repair.”
Rotation Medical’s bioinductive implant won FDA approval in March 2014. The implant was designed to induce new tissue growth after a patient suffers a rotator cuff tendon tear.
