Devices

Edwards Expands SAPIEN for Asymptomatic Patients

FDA has approved Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for patients with severe aortic stenosis who show no symptoms. The approval extends the use of the platform, including the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves, to a broader patient population (asymptomatic patients) based on results from the EARLY TAVR trial, which showed significantly better outcomes for asymptomatic patients treated with Edwards’ TAVR compared to those under standard clinical surveillance, the company says.

According to the trial data, 26.8% of those who received the TAVR procedure experienced death, stroke, or unplanned cardiovascular hospitalization, compared to 45.3% in the surveillance group.

“There is an urgent need to change practice and TAVR guidelines,” Morristown Medical Center director and trial lead investigator Philippe Genereux is quoted in a company release as saying. “As we saw, patients initially considered asymptomatic can rapidly become symptomatic in unpredictable ways. Early intervention can significantly improve outcomes.”

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