Covidien Announces Launch of Therapeutic Device for Treatment of Resistant Hypertension

  Covidien Announces Launch of Therapeutic Device for Treatment of Resistant
  Hypertension

    The OneShot™ Renal Denervation Device Offers a Solution for Physicians
       treating Patients with High Blood Pressure who Fail Drug Therapy

Business Wire

MANSFIELD, Mass. -- January 16, 2013

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.

Covidien today announced the commercial launch of the OneShot Renal
Denervation System, an over the ...

Covidien 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. (Photo: Business Wire)

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.com to learn more about our business.

^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.

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Contact:

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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