Devices

FDA OKs Cordis Vascular Closure Device

FDA has approved a Cordis PMA for its Mynx Control Venous Vascular Closure Device (VCD), for cardiac ablation procedures with access sites from 6F-12F. The device features the company’s Grip Technology and has been shown to resorb three times faster than collagen-based sealants, the company says.

“In the prospective, randomized control ReliaSeal trial comparing manual compression versus Mynx Control Venous VCD in cardiac ablation procedures, Mynx Control Venous VCD met all clinical endpoints resulting in 100% procedure and device success.” Cordis says. The trial also demonstrated significant reductions between the device group and manual compression group in time to hemostasis (2.1 vs. 11.4 mins.), time to ambulation (2.6 vs. 5.14 hrs.), and time to discharge eligibility (3.1 vs. 5.5 hrs.), it adds.

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