Covidien Begins Overseas Launch of Renal Denervation System
January 16, 2013 — Covidien began the commercial launch of the OneShot Renal Denervation System, an over the wire balloon-based irrigated ablation catheter technology for the treatment of hypertension.
Placed percutaneous, OneShot delivers radiofrequency (RF) energy in a circumferential manner to the renal arterial wall, and requires only a single treatment per artery. OneShot 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.
Hypertension affects one billion people worldwide of all ages.1 It occurs when the force of blood pushing against the vessel walls is too high, which can damage the vessels and cause life-threatening conditions. Hypertension is a chronic condition that significantly increases the risk of stroke, heart attack, heart failure and kidney disease.
“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 42 mmHg at six months, for the eight patients treated with the device in the study. 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.
For more information: www.covidien.com
1 The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, MD: National Institutes of Health: National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program; May 2003. NIH publication 03‐5233.