December 18, 2020
The U.S. Food and Drug Administration today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed in the U.S. for adults who have transfemoral or above-the-knee amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
“Today’s approval of the OPRA Implant System expands options for prostheses for individuals who have had above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses,” said Capt. Raquel Peat, Ph.D., MP.H., USPHS, director of the FDA’s Center for Devices and Radiological Health’s Office of Orthopedic Devices. “Prostheses can help people who have lost a leg due to trauma or cancer to regain mobility and to more easily participate in everyday activities.”
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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.
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