News Briefs: FDA Approves AF Catheter; Tax Reform Proposal; Renal Denervation
This article was originally published in The Gray Sheet
FDA approved a PMA supplement for Biosense Webster’s Thermocool SmartTouch, the first FDA-approved ablation catheter that can measure contact force in real time. J&J earns a CE mark for its Renlane renal denervation system. More news briefs.
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Results of the first major trial evaluating Biosense Webster’s contact-force-sensing ThermoCool SmartTouch catheter show that stability of contact between the ablation catheter and the ablated tissue substantially improves the effectiveness of cardiac ablation for atrial fibrillation, but the average contact force applied during the procedure does not appear to make a difference.
The full results of Medtronic’s SYMPLICITY HTN-3 trial, to be presented at the American College of Cardiology Scientific Sessions on March 29, could determine the fate of the renal denervation devices under development by several major companies for drug-resistant hypertension.
FDA panel unanimously endorses Inspire upper airway stimulator. Stryker buys Berchtold and Pivot. First randomized U.S. study of embolic protection during transcatheter aortic valve replacement approved. More news.