SOMERSET, N.J., July 11, 2012 /PRNewswire/ -- Terumo
Interventional Systems, a strategic business unit of Terumo Medical
Corporation, a U.S. subsidiary of Terumo Corporation, today
announced the completion of U.S. patient enrollment in the
Occlusive/Stenotic Peripheral Artery
REvascularization StudY (OSPREY) designed to
evaluate the safety and effectiveness of the MISAGO™ Self-expanding
Stent System. OSPREY is a single-arm, multi-center,
non-randomized prospective clinical trial for the treatment of
atherosclerotic stenoses and occlusions of the superficial femoral
artery that included 200 patients in 31 centers in the U.S. and 100
patients in seven centers in Japan.
(Photo: http://photos.prnewswire.com/prnh/20120711/NY37622 )
A unique feature of this landmark study is that it
simultaneously enrolled patients in the U.S. and Japan as part of the larger Harmonization
by Doing (HBD) pilot program, a cooperative effort led by the
U.S. Food & Drug Administration, the MHLW/PMDA (Japan's regulatory body), Terumo Corporation,
based in Tokyo, Japan, and Terumo
Medical Corporation, based in Somerset, New Jersey. The HBD initiative
is intended to shorten the gap between product approvals in these
two significant world healthcare markets.
"OSPREY is Terumo Medical Corporation's first U.S. clinical
trial for a premarket approval (PMA) device and we are
exceptionally pleased with its progress. Terumo is greatly
appreciative of the tremendous support given by our U.S. clinical
investigators, which helped us meet the critical enrollment goal in
this landmark HBD initiative," said James
Rushworth, President of Terumo Interventional Systems and
Onset Medical Corporation. "The OSPREY trial and the MISAGO Stent
truly speak to our three strategic pillars of introducing
innovative technologies that create Clinical, Economic, and Quality
of Life Benefits."
The MISAGO Self-expanding Stent consists of a nitinol stent
pre-mounted on the distal portion of a rapid-exchange delivery
catheter system. The stent has three radiopaque markers
located on each end of the stent to help ensure accurate placement
in the lesion. The stent is currently available for sale in
Europe.
The first U.S. patient implant in the OSPREY trial occurred in
September 2010. The primary endpoints
of the U.S. arm of the OSPREY study are:
- Primary stent patency rate at one year as confirmed by duplex
ultrasound or angiography.
- Freedom from major adverse events within 30 days of the
procedure, which would result in target lesion revascularization,
amputation of the treated limb or death.
"Peripheral vascular disease is a leading cause of disability in
the U.S., affecting between 8 and 12 million Americans. It is
critical that physicians, and their patients, have faster access to
the latest technologies in order to maximize treatment options,"
said J. Fritz Angle, MD, Professor
of Radiology, University of Virginia,
and U.S. Principal Investigator in the OSPREY trial. "I look
forward to analyzing and discussing the OSPREY data with all of the
trial investigators. The international experience and testing
efficiencies obtained from our collective participation in this HBD
initiative could have a dramatic effect on the way important
medical devices reach the market in the future."
For more information about the OSPREY trial, contact
Joanna Murray, Clinical Project
Manager, Terumo Interventional Systems, 732-302-4900, extension
7210.
Terumo Interventional Systems
Terumo Interventional Systems (TIS) is a strategic
business unit of Terumo Medical Corporation. As a market leader in
entry site management and lesion access, TIS is committed to
pursuing unique technologies designed to enhance treatment of
coronary and peripheral endovascular diseases as well as driving
strategic initiatives focused on Critical Limb Ischemia, Complex
Coronary Intervention and Transradial Access. TIS directly
markets a full line of guidewires, catheters, introducer sheaths,
guiding sheaths and embolization products for use in a multitude of
different interventional procedures.
Terumo Medical Corporation
Founded in 1972 as a Terumo Corporation subsidiary, Terumo
Medical Corporation (TMC) develops, manufactures, and markets a
complete, solutions-based portfolio of high-quality medical devices
used in a broad range of applications for numerous areas of the
healthcare industry. TMC is comprised of two business
divisions: Terumo Interventional Systems and Terumo Medical
Products. The company places a premium on providing customers with
world-class products, training and education programs that drive
clear economic value, better clinical outcomes and improved Quality
of Life for patients.
Terumo Corporation
Tokyo-based Terumo
Corporation is one of the world's leading medical device
manufacturers with
$5 billion in sales and operations in
more than 160 nations. Founded in 1921, the company develops,
manufactures, and distributes world-class medical devices including
products for use in cardiothoracic surgery, interventional
procedures, and transfusion medicine; the company also manufactures
a broad array of syringe and hypodermic needle products for
hospital and physician office use. Terumo contributes to society by
providing valued products and services to the healthcare market and
by responding to the needs of healthcare providers and the people
they serve.
Terumo Corporation's shares are listed on the first section of
the Tokyo Stock Exchange (No. 4543, Reuters symbol , or Bloomberg
4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
SOURCE Terumo Interventional Systems
