Miach Orthopaedics has obtained expanded approval from the US Food and Drug Administration (FDA) for its BEAR Implant, a device targeting anterior cruciate ligament (ACL) injuries.
The regulator’s latest 510(k) clearance now encompasses use in children and adolescents of all ages and also includes partial ACL tears. Previously, this implant had received De Novo Approval in late 2020, limited to patients aged 14 and above with complete ACL ruptures.
Based in Westborough, Massachusetts, Miach Orthopaedics specialises in surgical implants that support tissue restoration.
BEAR, which expands to Bridge-Enhanced ACL Restoration, is a collagen-based device that promotes natural healing in torn ligaments.
Unlike traditional ACL reconstruction, which involves graft replacement, this device eliminates the need for additional surgical sites or donor tendons. This is achieved by enabling the body to repair itself through a minimally invasive process.
According to Miach Orthopaedics, surgeons place the implant between the torn ligament ends and utilise the patient’s blood to facilitate healing, thereby maintaining the original ligament attachments.
Miach Orthopaedics said that this FDA decision is particularly important for young athletes with ACL injuries, a common issue among this demographic. Traditional reconstructive procedures are complex in younger patients due to growth plates necessary for bone development, whereas the BEAR Implant provides a solution compatible with physiological growth, claimed the company.
Furthermore, Miach Orthopaedics explained that while many partial tears are managed with non-surgical methods such as therapy and bracing, surgery becomes necessary if instability persists or the damage is extensive. A notable number of partial tears progress to full ruptures in active youth, necessitating surgical intervention.
Miach Orthopaedics president and CEO Patrick McBrayer said: “The way ACL tears are treated is reaching an inflection point, and the BEAR Implant is a significant driving force.
“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.”
The FDA’s expanded approval is grounded in data from the BEAR III clinical trial and insights garnered from the Bridge Registry, where participants have recently completed their two-year evaluations.
