TUSTIN, Calif., July 2, 2012 /PRNewswire/ -- MicroVention, Inc.,
a wholly owned subsidiary of Terumo Corporation, today announced
that enrollment has begun in the Hydrogel Endovascular Aneurysm
Treatment (HEAT) clinical trial, a study of the use of coiling
technologies to treat intracranial aneurysms. This
prospective, randomized, international multicenter trial is
designed to compare clinical outcomes in patients treated with the
new generation of the MicroVention hydrogel coils to those treated
with bare platinum coils. The HEAT trial will enroll up to
600 subjects from approximately 30 sites around the world.
Bernard R. Bendok, M.D., a
neurosurgeon at Northwestern Memorial Hospital, who is the
principal investigator for the HEAT trial and Associate Professor
at Northwestern University Hospital in
Chicago, said, "Intracranial
aneurysms can be a devastating, life threatening condition with
approximately 30,000 people suffering from subarachnoid hemorrhage
each year in the USA alone. The
HEAT trial will allow us to better understand these lesions and
advance their treatment."
Richard Cappetta, President and
CEO of MicroVention, Inc., said: "The HEAT trial is intended to
provide evidence that our second-generation hydrogel coil
technologies provide superior long-term clinical outcomes compared
to bare platinum coils. In a recently published article in
The Lancet reporting on our earlier HELPS trial results,
MicroVention's first-generation HydroCoil® Embolic
System demonstrated superior angiographic outcomes at 18 months
compared to bare platinum coils.(1) We believe that, with a
comprehensive line of second-generation hydrogel technologies
utilized in the HEAT trial, which includes the
HydroFrame®, HydroFill® and
HydroSoft® embolic coils, improvement in clinical
efficacy should be even greater compared to bare platinum
coils. In addition, these new gel coils are much easier to
use due to their increased repositioning time, softer delivery
system and standardized microcatheter delivery."
A description of this clinical trial can be found at
http://clinicaltrials.gov/ct2/show/NCT01407952, as required by U.S.
law. To learn more about the HEAT trial email:
HEATtrial@northwestern.edu. For more information about
aneurysm symptoms and treatment, listen to a podcast about brain
aneurysms with Dr. Bendok, which is located at:
http://www.nmh.org/nm/podcast-brain-aneurysms.
(1) White PM., Lewis SC., Gholkar A et al. Hydrogel-coated coils
versus bare platinum coils for the endovascular treatment of
intracranial aneurysms (HELPS): a randomized controlled trial.
Lancet 2011; 377:1655-62.
About the HydroCoil® Embolic System
The HydroCoil Embolic System is a unique non-bioactive
endovascular embolization device combining MicroVention's platinum
microcoil technology with a proprietary hydrogel. The
hydrogel polymer is a biomaterial that begins to swell after a
brief period of contact with blood, giving physicians the ability
to precisely control delivery of the device. Once the
hydrogel swells, it provides improved filling of the aneurysm
without exerting pressure onto the aneurysm wall or adjacent coils.
The HydroCoil system combines the safety of platinum coils
with the filling and mechanical stability of hydrogel. The
HEAT trial will focus on the newer generations of the HydroCoil
Embolic System that are designed for ease of use together with the
benefits of hydrogel. The HydroCoil system offers a
therapeutic alternative to the current treatment choices of
platinum coils and neurosurgical clipping, and is also being used
clinically to treat fistula and peripheral vascular lesions.
About MicroVention, Inc.
MicroVention, Inc. is a U.S. subsidiary of Terumo
Corporation with its corporate headquarters in Tustin, California, and manufacturing and
administrative facilities in Santa
Ana and Aliso Viejo,
California, and San Jose,
Costa Rica. MicroVention is a developer, manufacturer and
marketer of innovative neuroendovascular technologies for the
treatment of vascular diseases in small vessels. MicroVention
products are sold throughout the world in more than 60
countries. For more information, visit
www.microvention.com.
About Terumo Corporation
Tokyo-based Terumo
Corporation is one of the world's leading medical device
manufacturers with $4 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 health care market and by responding
to the needs of health care 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.
Media Contact:
Cathy Demyanovich
Director, Corporate Communications
MicroVention. Inc.
800-990-8361
714-247-8000
SOURCE MicroVention-Terumo, Inc.
