Covidien has jumped into the renal denervation market for hypertension control with the purchase of Maya Medical last year and now with the release of the OneShot system developed by the subsidiary. The over the wire balloon-based irrigated catheter, like other competing systems just coming to market, delivers radiofrequency to the renal arterial wall, while requiring only a single treatment per artery.
The system received European clearance almost a year ago and has been undergoing clinical testing since. It will be made available this year in much of the world, but no word on any expected FDA approvals in the U.S.
Covidien’s RHAS (Renal Hypertension Ablation System) feasibility study results were presented by Dr. Ormiston, principal investigator, at the 2012 TCT congress in October 2012. The RHAS study results showed a mean reduction of 42 mmHg at six months, for the eight patients treated with the device in the study. Dr. Ormiston has also performed cases with OneShot as part of the RAPID (Rapid renal sympathetic denervation for resistant hypertension using the OneShot system) trial, a 50-patient study currently enrolling in Europe and New Zealand with expected enrollment completion in the early spring timeframe.