Connective tissue repair implant maker Miach Orthopaedics announced that it received FDA de novo clearance for its ACL repair implant.
Westborough, Mass.-based Miach said today in a news release that its Bridge-Enhanced ACL repair — BEAR — implant received the de novo marketing approval for treating anterior cruciate ligament (ACL) tears.
BEAR is touted as the first medical technology that is clinically proven to enable healing or restoration of a patient’s torn ACL, potentially moving the approach away from the traditional graft replacement for ACL tears which has been in place for more than 30 years.
The proprietary, bioengineered implant is designed to restore natural anatomy and function of the knee and is less invasive than the current standard of care. Miach observed better patient satisfaction in terms of readiness to return to sport and one-year pain and symptoms, too. The implant also does not require a second surgical wound or using a deceased donor’s tendon.
Miach plans to begin a limited market release of the BEAR implant in early 2021.
“There are a number of advantages to repairing a ligament instead of replacing it. That is why, more than 30 years ago, we set out to find a way to help the ligament heal itself,” Miach Orthopaedics founder & Boston Children’s Hospital/Harvard Medical School orthopaedic surgery professor Dr. Martha Murray said in the release. “We’ve been encouraged by the results of the clinical studies at Boston Children’s Hospital showing that repair using a BEAR Implant is a viable alternative to autograft ACL reconstruction. FDA approval validates the decades of work our teams have put into this technology and is truly rewarding. We are looking forward to seeing this technology become more widely available for patients everywhere.”
“ACL injuries are all too common among athletes of all ages and can be a career-ending injury in the NFL, which is why the NFL Players Association has been a sponsor of the BEAR clinical trials since the beginning,” added NFL Players Association VP Sean Sansiveri. “We’re gratified to have supported Miach Orthopaedics in the journey to bring a better option for treating ACL injuries to patients in the U.S.”