EIRs/483s

FDA OKs Medtronic In.Pact Balloon

FDA has approved a Medtronic PMA for the In.Pact AV drug-coated balloon, a paclitaxel-coated balloon indicated for treating failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis. Patients with ESRD rely on AV fistulae for hemodialysis, and over time vessel restenosis limits the ability to use AV fistulae effectively, the company says.

“In order to restore function, patients often undergo one to three maintenance procedures per year, which can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system,” Medtronic says. Clinical trial data showed that the device can extend the time between reinterventions “by maintaining AV access site patency, therefore maximizing a patient's uninterrupted access to lifesaving dialysis care,” it says. Data demonstrated the “comparable safety and the superior effectiveness of In.Pact AV DCB compared to percutaneous transluminal angioplasty (PTA).” Also, patients treated with In.Pact maintained patency longer and required 56% fewer reinterventions compared to those treated with standard PTA through six months.

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