|
Bradenton Cardiology Center
is First Site in the U.S. to Implant the Terumo Misago™ Stent System
Landmark Pilot Study Simultaneously
Enrolling in the U.S. & Japan
The "Harmonization By Doing" Program
Seeks to Streamline Product Approval Process Through Unprecedented
International Regulatory Cooperation
|
 |
MISAGO Peripheral
Self-
Expanding Stent System |
|
September 9, 2010 --
Bradenton, Florida -- The Bradenton Cardiology Center
announced today that it became the first center in the U.S.
to implant the MISAGO™ Peripheral
Self-expanding Stent System as part of the Occlusive/Stenotic
Peripheral artery REvascularization StudY (OSPREY), which will
evaluate the safety and efficacy of the MISAGO Stent System
for use in the superficial femoral artery (SFA).
A unique
feature of
the OSPREY clinical trial is that it will simultaneously
enroll patients in the U.S. and Japan. |
Referred to as “Medical Device Collaborative
Consultation and Review of Premarketing Applications" under the larger Harmonization
by Doing (HBD) initiative, the OSPREY trial was selected as one of two projects
to pilot this approach, which is intended to shorten the gap between product
approvals in these two significant world healthcare markets. The pilot program
is a cooperative effort led by the U.S Food & Drug Administration, the MHLW-PMDA
(Japan’s regulatory bodies), Terumo Corporation based in Tokyo, Japan, and
Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation.
Srinivas Iyengar,
MD
Bradenton Cardiology |
|
"We are pleased to be
the first U.S. center to kick off this exciting international
trial to evaluate the safety and efficacy of the MISAGO Stent
System for treating patients with peripheral artery disease," said
Srinivas Iyengar, MD, primary operator and site Principal Investigator
for the OSPREY trial. "This is a unique and exciting opportunity
for myself and the Bradenton Cardiology Center to be a part
of the first international initiative to streamline the regulatory
process to facilitate future medical device approvals between
countries."
In the U.S., OSPREY is a single-arm, multi-center, non-randomized
prospective clinical trial for the treatment of atherosclerotic
stenoses and occlusions of the SFA. In Japan, there are two
arms of the study, 50 patients receiving the MISAGO Stent System
and 50 patients receiving percutaneous transluminal angioplasty
(PTA). |
The primary endpoints of the U.S. 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.
The study will include up to 350 patients, a maximum of 250 patients
in up to 30 centers in the U.S. and 100 patients in Japan. Japan received
regulatory approval to begin the trial last year and has already started
to enroll patients.
The MISAGO Peripheral Self-expanding Stent System 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 unique design distributes the dynamic superficial femoral artery
stress loads throughout the stent’s struts providing not only flexibility, but also durability against bending, compression, and torsion. The MISAGO Stent System features the first rapid-exchange (RX) delivery catheter for use in the SFA.
The MISAGO Stent System is manufactured in Japan by Terumo Corporation
and has been available in Europe since November 2007. To date, approximately
9000 femoral-popliteal units have been sold (7500 patients treated).
"Terumo Medical Corporation welcomes the Bradenton Cardiology Center into
the OSPREY trial and congratulates Dr. Iyengar and his colleagues on becoming
the
first U.S. center to implant the MISAGO Stent System as part of the Harmonization
By Doing program," said Juichi “Jim” Takeuchi, President and CEO, Terumo
Medical
Corporation. “As the first medical device company to embark on this unprecedented
initiative with two of the world’s most preeminent regulatory bodies, we look
forward to continuing to work with our U.S. clinical partners to enroll patients
into the OSPREY trial.”
About Peripheral Artery Disease
According to the American Heart Association, approximately eight million
Americans suffer from peripheral artery disease (PAD). Unfortunately,
PAD is often undiagnosed by healthcare professionals, because the symptoms
can be mistaken for some other condition. The most common symptoms
are cramping, pain or tiredness in the leg or hip muscles while walking
or climbing stairs. Typically, the pain goes away with rest, but flares
up again when walking resumes. Most cases of PAD can be managed with
lifestyle changes and medical therapy; however, left untreated this
condition can lead to gangrene and amputation of the affected limb.
Terumo Interventional Systems
Terumo Interventional Systems (TIS), a strategic business unit of Terumo
Medical Corporation, directly markets a full line of guidewires, catheters,
introducer sheaths, guiding sheaths and embolization products for use
in a multitude of different interventional procedures.
Interventional Radiologists, Interventional Neuroradiologists, Interventional
Cardiologists, and Vascular Surgeons are among the medical professionals
that depend upon TIS products to access and cross difficult-to-reach
lesions, thereby allowing therapeutic intervention in previously unreachable
vascular beds.
Terumo Medical Corporation
Founded in 1972 as a Terumo Corporation subsidiary, Terumo Medical
Corporation (TMC) develops, manufactures, and markets high-quality
medical devices used in a broad range of applications in numerous healthcare
markets. TMC manufactures a broad portfolio of needles and syringes,
entry-site management products, and a line of sterile connection devices
used in hospitals and blood banks worldwide.
Terumo Corporation
Tokyo-based Terumo Corporation is one of the world’s leading medical
device manufacturers with $3.0 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 <4543.T>, or Bloomberg 4543: JP) and is a component
of the Nikkei 225, Japan’s leading stock index.
Source: Terumo Medical Corporation
|
