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

Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its...
Cook Medical Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments
News | Cath Lab | March 20, 2019
March 20, 2019 — Cook Medical is recalling one lot of its...
DABRA Excimer Laser System Demonstrates Success in Treating PAD
News | Cath Lab | February 27, 2019
Ra Medical Systems Inc. announced a 98 percent success rate in the results from a 52-patient study using the company’s...
Edwards Lifesciences Recalls Swan-Ganz hemodynamic catheters.
Feature | Cath Lab | February 06, 2019
Edwards Lifesciences is recalling its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufa
Scientists Discover New Heart Attack Repair Pathway

A macrophage immune cell, with a dead cell (pink) that has been eaten, and a mitochondrion (green) between the dead cell and the nucleus. The study’s findings indicate that what the macrophage eats is taken up by the mitochondrion, which in turn communicates with the nucleus to activate the macrophage to promote tissue repair. Image courtesy of Northwestern Medicine.

News | Cath Lab | January 30, 2019
Northwestern Medicine scientists have discovered a novel signaling pathway that promotes healing after a heart attack....
Shockwave Initiates U.S. Pivotal Study for Coronary Intravascular Lithotripsy
News | Cath Lab | January 16, 2019
Shockwave Medical Inc. has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE...
National Academy of Engineering, Ohio University Award 2019 Russ Prize
News | Cath Lab | January 03, 2019
Ohio University and the National Academy of Engineering announced the 2019 Fritz J. and Dolores H. Russ Prize will be...
Overlay Init