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WASHINGTON Patients needing reconstruction of torn anterior cruciate ligaments (ACLs) no longer have to rely on grafts harvested from their own bodies or cadavers, with the FDA s authorization of a synthetic implant on Wednesday.
Called the Bridge-Enhanced ACL Repair (BEAR) Implant, the product is made from bovine collagen and is intended to bridge the gap between the torn ends of a completely ruptured ACL. The surgeon secures it with sutures and injects the patient s own blood into the implant during the procedure, which forms a clot that enables ligament healing. The implant itself is resorbed in about 8 weeks, the FDA said.
Dive Brief:
FDA has authorized a resorbable implant under the De Novo premarket review pathway that fills the gap between the torn ends of a patient’s anterior cruciate ligament (ACL), one of the most common knee injuries in the U.S.
Miach Orthopaedics synthetic device, made from bovine collagen and absorbed by the body in about 8 weeks, offers an alternative to traditional and invasive ACL reconstruction used to treat tears with harvested tendons. The company s Bridge-Enhanced ACL Repair (BEAR) surgical implant is indicated for skeletally mature patients, ages 14 or older, with complete ACL ruptures confirmed by MRI.
A surgeon secures the implant with sutures and injects the patient s own blood into it during the procedure with the intent of forming a device-protected clot that enables the body’s healing process, FDA said. The agency deemed the device safe and effective based on a 100-patient randomized controlled trial.
December 16, 2020
Today, the U.S. Food and Drug Administration granted marketing authorization under the De Novo premarket review pathway for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture.
“Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction,” said Capt. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Heal
FDA grants marketing authorization for new ACL implant
Today, the U.S. Food and Drug Administration granted marketing authorization under the De Novo premarket review pathway for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture.
Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction. Today s marketing authorization provides new options for the hundred