FDA clears first torn-ACL implant (MassDevice)
Website - Miach Orthopaedics
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...
