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OneShot Renal Denervation System Launched in International Markets
Covidien has announced the commercial launch of its OneShot Renal Denervation System and roll out of the device in Europe, Middle East, Africa, Asia and Latin America, which will take place over the next several months.
The device, which is intended for the treatment of resistant hypertension, delivers radiofrequency energy to the renal arterial wall in a circumferential manner, requiring only one treatment per artery.
The results of the RHAS feasibility trial, testing the device in 8 patients, were presented at Transcatheter Cardiovascular Therapeutics Scientific Sessions in October 2012. According to a press release issued by the manufacturer, patients experienced a mean reduction of 44 mm Hg at 6 months.
Currently, the RAPID trial, which will examine the device in 50 patients with resistant hypertension, is enrolling in Europe and New Zealand, with enrollment completion expected in early spring.
The renal denervation system received CE mark approval in February 2012.