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MicroVention, Inc. Announces First Patient Enrollment in Clinical Trial to Compare Coiling Technologies for Treating Brain Aneurysms


7/2/2012 10:39:07 AM

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 <4543.T>, 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.



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