Cook Medical Inc.’s first-in-class peripheral-artery-treating paclitaxel-eluting stent demonstrated 83% freedom from target-lesion revascularization at 36 months, compared to 70.2% TLR exhibited by control-group patients with femoropopliteal disease who were treated with standard angioplasty and bare-metal stents in the company’s 479-patient pivotal trial, investigators reported Aug. 13 at a clinical meeting in Japan. Cook has previously reported up to two year data from the trial. The stent gained support from an FDA advisory panel last fall, and Cook is awaiting a final FDA decision on its PMA, which is expected this month. (See Also see "Cook’s Zilver PTX Peripheral Drug-Eluting Stent Sails Through FDA Panel" - Medtech Insight, 17 October, 2011..)
Sound Interventions issued interim three-month data for its ultrasound-based renal denervation system for treatment-resistant hypertension Aug. 14. Average blood pressure decreased by -23.1/-11.9 mm Hg based on 24-hour ambulatory monitoring...
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