Devices

FDA Approves Expanded Use for Edwards’ Sapien 3 Device

FDA has approved an expanded indication for Edwards Lifesciences’ Sapien 3 Transcatheter Heart Valve for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high. “For the first time, a regulatory agency is approving a transcatheter heart valve as a valve-in-valve treatment when bioprosthetic mitral or aortic valves fail in patients who are at high or greater risk of complications from repeat surgery,” CDRH Division of Cardiovascular Devices director Bram Zuckerman is quoted in a release as saying.

Expanded approval was based on data from the Transcatheter Valve Therapy Registry, a partnership of the American College of Cardiology and the Society of Thoracic Surgeons. “The registry data showed that more than 85% of patients who underwent aortic or mitral valve-in-valve procedures experienced clinically meaningful improvement in their heart failure symptoms 30 days after the procedure, as shown by their New York Heart Association (NYHA) Classifications.”

Previously, the device was approved as an alternative option to surgical aortic valve replacement for patients with native aortic stenosis whose risk for death or severe complications from surgery is high or greater. In 2016, the agency expanded its use to include patients who are at intermediate surgical risk for death or complications.

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

Read more

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