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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)-- 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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