May 8, 2012—Covidien (Mansfield, MA) announced that it will introduce its new OneShot renal denervation system at the EuroPCR congress in Paris next week. The OneShot system was developed by Maya Medical (Campbell, CA) and received CE Mark clearance in February 2012.
According to Covidien, the OneShot system is designed to treat patients with hypertension who are nonresponsive to traditional medical therapy. The system features an irrigated, radiofrequency-based balloon catheter used for targeted ablation of sympathetic nerves located within the adventitia of the renal arteries for the purpose of inhibiting sympathetic nerve pathways that can contribute to the progression of hypertension.
Covidien also announced the commencement of the post-CE Mark approval clinical trial, RAPID (Rapid Renal Sympathetic Denervation for Resistant Hypertension), which will enroll patients throughout Europe and at a site in New Zealand.
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