Covidien has introduced a new therapeutic device to treat patients with resistant hypertension.
The CE-marked OneShot Renal Denervation system is an over the wire balloon-based irrigated catheter device which is implanted under the skin for delivering radiofrequency energy in a circumferential manner to the renal arterial wall.
Mercy Angiography medical director John Ormiston said 10% to 15% population with hypertension do not 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," Ormiston added.
During the company’s Renal Hypertension Ablation System (RHAS ) feasibility study, the device has shown a mean reduction of 42 mmHg at six months in eight patients.
The device is also being studied as part of Rapid renal sympathetic denervation for resistant hypertension using the OneShot system (RAPID) trial, a 50-patient study currently enrolling in Europe and New Zealand with expected enrollment completion in the early spring of 2013.
OneShot system will be made available in Europe, Middle East, Africa, Asia and Latin America in the coming months, claims the company.