Feature | January 16, 2013

Covidien Begins Overseas Launch of Renal Denervation System

The OneShot device offers a solution for physicians treating patients with high blood pressure who fail drug therapy

The OneShot renal denervation system uses a spiral shaped electrode to ablate the renal artery at one time. Most renal denervation catheters require multiple ablations.

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

 

Reference:

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.

 

 

Related Content

Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
Technavio report, renal denervation devices, 2015
News | Renal Denervation| August 23, 2016
August 23, 2016 — Technavio analysts forecast the global...
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
News | Peripheral Arterial Disease (PAD)| August 22, 2016
Avinger Inc. recently announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’...
sleep apnea, hypertension, clinical study, Science Signaling, University of Chicago
News | Hypertension| August 22, 2016
Obstructive sleep apnea is a common cause of high blood pressure. In the Aug. 17, 2016, issue of the journal Science...
DMC Heart Hospital, Detroit Medical Center, complex percutaneous intervention education course, PCI, cath lab training
News | Cath Lab| August 22, 2016
The Detroit Medical Center (DMC) Heart Hospital recently completed a Complex Percutaneous Intervention education course...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
Covidien, Medtronic, TurboHawk, Atherectomy system

The Medtronic TurboHawk atherectomy system. 

Feature | Atherectomy Devices| August 18, 2016 | Dave Fornell
Due to poor outcomes from percutaneous transluminal angioplasty (PTA) ballooning of vessels alone, or of stenting in
Sapien III, Sapien 3, PARTNER III, FDA approval, expanded indication, intermediate risk patients

The Sapien 3 valve has a skirt of fabric at its base that has significantly reduced issues of paravalvular leak, which was an issue with the first generation Sapien device. 

Feature | Heart Valve Technology| August 18, 2016 | Dave Fornell
August 18, 2016 — The U.S.
Corindus Corpath, Acist Medical RXi and CVi, Fairview Southdale Hospital, Minnesota, cath lab
News | Cath Lab| August 17, 2016
Corindus Vascular Robotics Inc. and Acist Medical Systems Inc. are providing Fairview Southdale Hospital, Edina, Minn...
Overlay Init