The US Food and Drug Administration (FDA) has cleared Miach Orthopaedics Bridge-Enhanced ACL Restoration (BEAR) implant for expanded use in treating complete and partial anterior cruciate ligament (ACL) tears in children.
The company’s BEAR implant, which gained de novo approval from the FDA in 2020, was previously indicated for treating skeletally mature patients aged at least 14 years old and with complete ACL tears as confirmed by magnetic resonance imaging (MRI).
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The implant is injected with a small amount of a patient’s blood and attached between the torn ends of the ACL. It is designed to heal the torn ends of the ACL back together while maintaining its original attachments to the femur and tibia, as the ACL heals, the implant gets resorbed by the body.
ACL reconstruction is generally viewed as a more complicated procedure in a growing child compared to adults due to their open growth plates. According to Miach, the BEAR implant offers a more natural solution to ACL injuries and works with a child’s body as the musculoskeletal system continues to develop.
In 2021, the company initiated the BEAR III post-market study to continue gathering clinical evidence on the implant with a planned follow-up period of ten years. Miach’s previous BEAR I/II studies were used to support the implant’s de novo approval.
Miach president and CEO Patrick McBrayer commented: “Since the BEAR implant was approved for commercial use four years ago, we have been proud to offer patients the opportunity to restore their native ACL anatomy without the need for more invasive reconstructive surgery.
“This FDA clearance is a significant step forward in our mission to change the standard of care in ACL surgery.”
According to a GlobalData market model, the orthopaedic equipment market is growing at a CAGR of 3% and is forecast to hit a valuation of around $72.3bn by 2033, up from around $53.5bn in 2023.
Elsewhere in the orthopaedic space, Zimmer Biomet launched a new campaign earlier this month featuring Hollywood actor Arnold Schwarzenegger as a spokesperson for an online community for patients with mobility issues.
Last month, the FDA granted 510(k) clearance to startup Atreon Orthopedics’s BioCharge Autobiologic Matrix, a bioresorbable synthetic implant for enhancing rotator cuff repair integrity.
