Devices

ACL Implant Gains De Novo Authorization

FDA has granted a de novo marketing authorization for Miach Orthopedics’ anterior cruciate ligament (ACL) implant for ACL reconstruction to treat ACL tears. The Bridge-Enhanced ACL Repair (BEAR) Implant is an alternative to traditional reconstruction and does not require the use of harvested tendons for ACL repair. The device is a resorbable implant made from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patient’s ACL. “The patient’s own blood is injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot that enables the body’s healing process,” an FDA release says. “Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body’s own tissue.”

Device authorization is based on data from a randomized controlled trial of 100 subjects with complete ACL rupture. In the study, 65 patients received the BEAR Implant and 35 members of the control group received ACL reconstruction with autograft (using their own tendon from another part of the body), FDA says. “At the two-year mark, patients who received the BEAR Implant reported an average score of 88.6 and control subjects reported an average score of 84.6 using the International Knee Documentation Committee Subjective Score, a patient-reported outcome measure (questionnaire) that asks questions about symptoms related to pain and stiffness, sports activity and knee function,” it says. Those with the implant also had a laxity that, on average, was greater by 1.7 mm in the treated knee than that of the untreated knee, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome