Covidien's OneShot Renal Denervation System Launched in International Markets

January 16, 2013—Covidien (Mansfield, MA) announced the international commercial launch of the OneShot renal denervation system, an over-the-wire, balloon-based irrigated catheter technology for the treatment of hypertension.

According to Covidien's press release, OneShot is placed percutaneously and delivers radiofrequency energy to the renal arterial wall in a circumferential manner, requiring a single treatment per artery. The device received CE Mark approval in February 2012 and has been undergoing clinical trial evaluation in New Zealand and Europe. OneShot will be commercially introduced in Europe, the Middle East, Africa, Asia, and Latin America over the next several months. The device is currently not available for sale in the United States.

As summarized by Covidien, results from the RHAS (Renal Hypertension Ablation System) feasibility study, which evaluated the OneShot device study, showed a mean reduction of 42 mm Hg at 6 months for the eight patients treated with the device in the study.

John Ormiston, MD, served as principal investigator for Covidien's RHAS study and presented the results at the TCT 2012: Transcathether Cardiovascular Therapeutics conference in Miami, Florida in October 2012. Dr. Ormiston is Medical Director for Mercy Angiography, Auckland, New Zealand.

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.

In Covidien's announcement, Dr. Ormiston commented, “Pharmaceutical treatment is the standard of care for hypertensive patients worldwide. Of the hypertension population, 10% to 15% do not adequately respond to medications and are deemed a resistant or refractory hypertension patient. These patients are expected to benefit from OneShot, which offers a solution with a much shorter procedure time than with currently available solutions—this could translate into much less pain for patients.”