Covidien has announced the commercial launch of its OneShot renal denervation system, an over-the-wire balloon-based irrigated catheter technology, for the treatment of hypertension.
Placed percutaneously, a company press release explains, OneShot delivers radiofrequency energy in a circumferential manner to the renal arterial wall, and requires only a single treatment per artery. The system received the CE Mark in February 2012 and has been undergoing clinical trial evaluation in New Zealand and Europe. The product will be rolled out in Europe, Middle East, Africa, Asia and Latin America over the next several months.
“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,” said Dr John Ormiston, Medical Director for Mercy Angiography, Auckland, New Zealand. “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.”
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 42mmHg 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.
Hypertension is the most common cardiovascular disease,” said Stacy Enxing Seng, President, Vascular Therapies, Covidien. “The entry into this market broadens our innovation focus and enables Covidien to positively impact the lives of millions of patients worldwide who are resistant to medical management of hypertension.”