Covidien Joins Renal Denervation Party With OneShot™ Launch

In short

Covidien has announced the commercial launch of the OneShot™ Renal Denervation System, an over the wire balloon-based irrigated catheter technology for the treatment of high blood pressure or hypertension.


Last May(2012)  Covidien acquired Maya Medical with its RF balloon renal denervation system called OneShot. Now the company is ready to commercialise the device and is planning to roll it out in Europe, Middle East, Africa, Asia and Latin America over the next several months.

So what’s the USP for OneShot? Well, the clue’s in the name.

Maya designed its OneShot to deliver radiofrequency (RF) energy in a circumferential manner to the renal arterial wall, zapping the sympathetic nerves that lie around the renal arteries. Covidien says OneShot requires only a single treatment per artery, which contrasts with at least one of the other devices already out there.

The huge interest in what could be one of the most revolutionary developments in healthcare for many years, means OneShot is joining a growing group of devices.

Covidien’s RHAS (Renal Hypertension Ablation System) feasibility study results were presented at the 2012 TCT congress in October 2012 by Dr. John Ormiston, principal investigator and Medical Director for Mercy Angiography, Auckland, New Zealand. 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.

Physician comments

“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. Ormiston. “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.”

Company comments

“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.”

“Covidien is excited to introduce this innovative next generation technology to help physicians address this unmet medical need,” said Dr. Mark Turco, Chief Medical Officer, Vascular Therapies, Covidien. “Advances like these benefit patients through improved medical outcomes.”

Regulatory status

OneShot received the CE Mark in February 2012 and has been undergoing clinical trial evaluation in New Zealand and Europe. It is not approved for sale in the United States.

Source: Covidien, Business Wire