Drugs

Boston Scientific Recalls Cryoablation Catheters

Boston Scientific has recalled (Class 1 — use instructions update) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula (AE fistula) risks. AE fistula is a known and inherent risk for patients undergoing catheter ablation for atrial fibrillation, according to the company. “Although uncommon, esophageal injury is a potentially life-threatening complication due to proximity of the esophagus to the posterior left atrium,” it says.

Since launching the devices in 2020, Boston Scientific says it has received seven such reports (worldwide) following atrial fibrillation ablations; four of them associated with a patient death.

“Detailed investigation of the available data associated with these AE fistula events did not identify product performance-related issues with any component of the cryoablation system,” the company says. “However, frequency and intensity of cryoablation applications were observed as possible contributing factors. Therefore, Boston Scientific is updating the POLARx and POLARx FIT cryoablation balloon catheter IFUs [instructions for use] to emphasize the risk of AE fistula, as well as practices that may reduce this risk.”

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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’

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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