FINAL PUBLISHED TRIAL DATA IN THE LANCET SUPPORTS SAFETY AND EFFECTIVENESS OF MICROVENTION-TERUMO’S HYDROCOIL® EMBOLIC SYSTEM FOR TREATMENT OF CEREBRAL ANEURYSMS

International Clinical Trial Results Show Statistically Significant Angiographic Reduction in Major Recurrence Rates with the HydroCoil Embolization System

TUSTIN, CA. – May 31, 2011 – MicroVention-Terumo, Inc., a leader in developing, manufacturing and marketing interventional neurovascular devices, announced today the final 18-month follow-up data in a landmark international study. The HydroCoil® Endovascular Aneurysm Occlusion and Packing Study (HELPS) published in The Lancet, showed that the HydroCoil Embolic System for treating cerebral aneurysms reduced recurrence and retreatment rates and provided improved outcomes in study patients when compared to bare platinum coils. A cerebral aneurysm is an abnormal, weakened area on the wall of a blood vessel in the brain that causes it to bulge or balloon out. If a cerebral aneurysm ruptures, it can cause a hemorrhagic stroke, a serious medical condition, which can lead to brain damage and death.

HELPS was a prospective, randomized controlled trial that compared the results from the HydroCoil system to results from bare platinum coils. The 500-patient, independently-run, multicenter, multinational 18-month trial was the first comparative adjudicated study completed since the International Subarachnoid Aneurysm Trial (ISAT) was presented in 2002. HELPS results were published in the prestigious journal, The Lancet, by the lead author and primary investigator, Philip White, M.D., of Western General Hospital in Edinburgh, Scotland.

“Our study shows that the non-invasive techniques for treating brain aneurysms are getting better.  Hydrogel coated coils offer an improved treatment for ruptured aneurysms and coiling has a faster recovery than having to have brain surgery and come with less risk as well, which is great news for the thousands of people affected by this condition each year,” said Dr. White.

HELPS Trial results showed that the HydroCoil system, based on a microporous expandable hydrogel, proved to be a more stable solution for endovascular occlusion of aneurysms than bare platinum. The HydroCoil implant is a non-bioactive coil that combines platinum with an expanding hydrogel polymer which provides the features of greater aneurysm volume filling with biologically inert material for natural tissue proliferation.

Angiographic results from an independent core lab indicated there was a statistically significant decrease (8.6%) in major aneurysm recurrence with the HydroCoil system arm as compared to bare platinum control arm. Aneurysms in the trial ranged in size from 2 mm to 25 mm, and 84% of all aneurysms were medium and large in size.

Key results of the trial demonstrated:

• HydroCoil implants had statistically significant more stable angiographic results with a significant decrease in major remnant/recurrence rates.
• The primary composite endpoint, while neutral, showed a strong trend favoring the HydroCoil Embolic System.
• There was a very low retreatment rate: 3% HydroCoil system arm vs. 4% bare platinum control arm.
• The effect of the HydroCoil system on outcomes was superior in ruptured aneurysms: 68% HydroCoil implants vs. 50% bare platinum implants.
• The HydroCoil system had less thromboembolic complications: 5.6% vs. 10% with bare platinum¹.
• HydroCoil implants resulted in a higher packing density with less coil length (reduction of 20%¹ as compared to bare platinum) due to its expansion properties: 63.9% for HydroCoil implants and 23.2% for bare platinum implants.
• Outcomes were superior when the targeted amounts of HydroCoil implants were achieved in aneurysms (≥50% HydroCoil implant length per protocol).

“We are very pleased with the exceptional results from this landmark trial. It continues to validate findings from previous multi-center and single-center trials, which is that the HydroCoil system provides excellent results in reducing aneurysm recurrence and retreatment in a wide range of cerebral aneurysms as compared to bare platinum coils,” said Richard Cappetta, President and Chief Executive Officer of MicroVention-Terumo.

Procedural safety and efficacy results for HELPS, previously published in 2008, found that the HydroCoil system can be safely used in a wide spectrum of aneurysms with a risk profile equivalent to that of bare platinum coils¹.

“MicroVention-Terumo is dedicated to clinical research and studies that focus on the science of interventional neuroendovascular surgery. Having the results of this important study published in a journal as prestigious as The Lancet is a real testament to the outstanding work and dedication of Dr. White and all of the HELPS collaborators,” Mr. Cappetta added.

Since the HELPS patient enrollment was completed in February 2007, MicroVention-Terumo has continued to innovate the HydroCoil line of coils, including the HydroSoft® finishing coil for filling small spaces that provides hydrogel at the neck of the aneurysm, and the HydroFrame® framing coil that provides optimal framing of the aneurysm with the clinical benefits of hydrogel.

The trial was based in the United Kingdom and managed by the Lothian Health Board with support from UK’s National Health Service. A total of 24 worldwide medical centers participated. The Core Lab that independently reviewed the results was Centre Hospitalier de l'Université de Montréal (CHUM) in Montreal, Quebec, Canada.

About the HydroCoil Embolization System
The HydroCoil Embolic System is a unique non-bioactive endovascular embolization device combining the Company’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 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.

¹ White PM, Lewis SC, Nahser H, et al. HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial):
Procedural Safety and Operator-Assessed Efficacy Results. AJNR Am J Neuroradiol 2008 Feb:29 (2) 217-223

About MicroVention-Terumo, Inc. MicroVention-Terumo (www.microvention.com) develops innovative neuroendovascular technologies for the treatment of vascular diseases in small vessels and is committed to developing and manufacturing the highest quality products for its customers and patients.  MicroVention products are sold throughout the world in 62 countries. In March 2006, MicroVention merged with Tokyo-based Terumo Corporation, an international manufacturer and provider of general hospital, cardiac, vascular and home healthcare products.  For more information call Cathy Demyanovich 1-800-990-8368.

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CODMAN LAUNCHES SOFTEST ENDOVASCULAR FINISHING COIL(1)

New XTRASOFT™ ORBIT GALAXY™ Coil with TRUSEEK™ Technology Designed to Seek and Fill Open Spaces in Cerebral Aneurysms

CARLSBAD, CA – JULY 26, 2010 – Codman & Shurtleff, Inc. (Codman), a global neuroscience and neurovascular company, today announced the launch of the stretch resistant XTRASOFT™ ORBIT GALAXY™ Coil (XTRASOFT), the softest endovascular finishing coil (1) for use in the treatment of cerebral aneurysms. XTRASOFT is the first in a family of coils known as the ORBIT GALAXY™ Detachable Coil System, Codman’s next generation, stretch resistant coil platform.

The announcement was made here at the Society of NeuroInterventional Surgery (SNIS) 7th Annual Meeting, where Codman is featuring its entire line of neurovascular solutions.

XTRASOFT with TRUSEEK™ Technology features a unique, complex, random loop design.  The coil’s shape makes it highly conformable, enabling the device to seek and fill open spaces in cerebral aneurysms for higher packing densities, which have been correlated with low patient retreatment rates.(2)(3)(4)(5)  XTRASOFT is also the first finishing coil to feature an outer diameter (OD) of 0.012 inches, which delivers significantly higher packing volume per cm of length than comparable 0.010-inch systems.

XTRASOFT is deployed using the ORBIT GALAXY Delivery System, an innovative system that offers flexibility and softness at the distal end to minimize microcatheter movement, helping physicians maintain optimal positioning within the aneurysm and enabling the placement of more coils.(6) The XTRASOFT coils are available in diameters from 2 mm to 4 mm and lengths from 1.5 cm to 10.0 cm.

“The softness of the coils combined with their complex, random loop design allows physicians to tightly pack the aneurysm and provides additional protection against rupture.  This is particularly helpful at the end of the procedure when only a few open spaces remain. These coils find the open spaces and fill them,” said In Sup Choi, MD,* Director of Interventional Neuroradiology at Lahey Clinic in Burlington, MA and one of the first physicians to use XTRASOFT.

Endovascular coils are inserted directly into the aneurysm through a microcatheter, a small, thin, hollow tube, to seal off the aneurysm, block blood flow and prevent rupture.  Finishing coils are small, soft coils used at the final stages of an aneurysm coiling procedure.

“XTRASOFT builds on Codman’s proven coil technology platform and is designed to fill unmet clinical needs,” said P. (Laxmin) Laxminarain, Worldwide President of Codman.  “Soon we expect to introduce new advances in framing and fill coils as part of the ORBIT GALAXY family that along with XTRASOFT will help set a new standard in endovascular coiling.”
XTRASOFT Coils leverage the same random loop design and delivery system as Codman’s proven TRUFILL DCS ORBIT® coil.  In the Complex Registry, an international registry with 37 centers that collected data about the TRUFILL DCS ORBIT coils, midterm results included a retreatment rate of 5.1 percent across all aneurysms and 2.4 percent in small aneurysms and average packing densities of 31 percent.(3)  These results were achieved prior to the introduction of stretch resistance technology and XTRASOFT Finishing Coils.

A cerebral aneurysm is an abnormal bulge in the wall of an artery or blood vessel in the brain that, according to the American Stroke Association, affects 3 to 5 million people in the United States.(7) Untreated aneurysms can be fatal or lead to hemorrhagic stroke or bleeding into or around the brain.  The National Institute of Neurological Disorders and Stroke (NINDS) estimates hemorrhagic strokes account for about 20 percent of the 700,000 strokes Americans suffer each year.

About Codman & Shurtleff, Inc.
Codman is a global neuroscience and neurovascular company that develops and markets a wide range of products and solutions for the diagnosis and treatment of neurological disorders including chronic pain management, adult and pediatric hydrocephalus, neuro critical care, aneurysm and stroke prevention and management. Codman is part of the DePuy Family of Companies. The DePuy Family of Companies has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision – Never Stop Moving™ – to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world.  Visit www.depuy.com for more information.
 

* In Sup Choi, MD is a consultant for Codman & Shurtleff, Inc.
(1) Compared with the following finishing coils: AXIUM™, GDC®-10 ULTRASOFT®, DELTAPLUSH™, HYPERSOFT™.  Test report on file at Codman.
(2) Slob MJ, et al. “Influence of coil thickness on packing, re-opening and retreatment of intracranial aneurysms: a comparative study between two types of coils.” Neurological Research 2005;27(1).
(3) Hirsch J, et al. “Midterm clinical experience with a complex-shaped detachable platinum coil system for the treatment of cerebral aneurysms: TRUFILL DCS ORBIT detachable coil system.” Journal of Vascular and Interventional Radiology 2007;18:1487-94.
(4) Wakhloo A, et al. “Complex-shaped platinum coils for brain aneurysms: higher packing density, improved biomechanical stability and midterm angiographic outcome.” American Journal of Neuroradiology 2007;28:1395-40.
(5) Sluzewski M, et al. “Relationship between aneurysm volume, packing and compaction.” Radiology 2004;231:653-8.
(6) Test report on file at Codman Neurovascular.
(7) American Stroke Association. “What You Should Know About Cerebral Aneurysms.” June 2009. Available from: http://www.americanstrokeassociation.org/presenter.jhtml?identifier=3067291

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