Devices

Intact Vascular PMA for Endovascular System Approved

FDA has approved an Intact Vascular PMA for the Tack Endovascular System, a dissection repair device implanted post-angioplasty in patients with peripheral arterial disease. Approval was based on data from the company’s Tack Optimized Balloon Angioplasty II (TOBA II) pivotal trial, which demonstrated safety and effectiveness. The trial met all primary endpoints with 92% of dissections completely resolved following treatment, according to the company.

It says inflation of an angioplasty balloon and resulting mechanical stress injures vessels and creates dissections. “These dissections are prevalent, underdiagnosed and underestimated,” it says. “If left untreated, dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures.”

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