The
OneShot™ Renal Denervation Device Offers a Solution for Physicians treating
Patients with High Blood Pressure who Fail Drug Therapy
MANSFIELD,
Mass. - Thursday, January 17th 2013 [ME NewsWire]
(BUSINESS
WIRE/ME NewsWire)-- Covidien(NYSE: COV), a leading global provider of
healthcare products, today 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.
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. 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.
"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.”
ABOUT
COVIDIEN
Covidien
is a leading global healthcare products company that creates innovative medical
solutions for better patient outcomes and delivers value through clinical
leadership and excellence. Covidien manufactures, distributes and services a
diverse range of industry-leading product lines in three segments: Medical
Devices, Pharmaceuticals and Medical Supplies. With 2012 revenue of $11.9
billion, Covidien has 43,000 employees worldwide in 70 countries, and its
products are sold in over 140 countries. Please visit www.covidien.comto learn
more about our business.
1The
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.
________________________________________
Contacts
Covidien
David T.
Young, 508-452-1644
Manager,
External Communications
Vascular
Therapies
david.young@covidien.com
or
Bruce
Farmer, 508-452-4372
Vice
President
Public
Relations
bruce.farmer@covidien.com
or
Cole
Lannum, CFA, 508-452-4343
Vice
President
Investor
Relations
cole.lannum@covidien.com
or
Todd
Carpenter, 508-452-4363
Director
Investor
Relations
todd.carpenter@covidien.com
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