Devices

Heart Valves Get Expanded Indication

FDA has approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves. These transcatheter valves – Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery.

“In low risk patients, open-heart surgery has been the standard-of-care for aortic valve replacement,” an FDA release says. “However, the procedure to insert a transcatheter heart valve is less invasive, and involves a smaller incision and shorter recovery time than open-heart surgery.”

As part of the approval, FDA says it is requiring each manufacturer to continue to follow patients enrolled in their randomized studies for 10 years to further monitor transcatheter aortic valve safety and effectiveness, including long-term valve durability. The device makers will also participate in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry to provide the agency with additional postmarketing surveillance over the 10-year period.

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