Devices Interventional Radiology Neurology FDA

 News Release - July 30, 2007

ev3 Receives CE Mark Approval for the Axium(TM) Detachable Coil System

Novel Device for Treatment of Aneurysm Now Available Globally

PLYMOUTH, Minn.--(HSMN NewsFeed)--ev3 Inc. (NASDAQ:EVVV ) has announced that it received CE Mark approval for its Axium Detachable Coil System ("Axium"). Axium was approved for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. It is also intended for use in the European Union for the treatment of peripheral vascular abnormalities.

Axium incorporates several innovative technologies designed to meet the performance "wish list" of a diverse group of leading neurosurgeons and interventional neuroradiologists. The design, development and testing of this new coil system was a highly collaborative process led by a dedicated team of ev3 engineers and leading coiling experts from around the world, including Gary Duckwiler, M.D., Professor of Interventional Neuroradiology at the University of California, Los Angeles, as well as Saruhan Cekirge, M.D. and Isil Saatci, M.D., both Professors of Neuroradiology/Interventional Neuroradiology at the Hacettepe University School of Medicine Ankara, Turkey.

Unique features and benefits of Axium reflect many of the "wish list" requirements identified by the team, including:

• A high degree of coil conformability, which facilitates the physician's goal of more easily and completely filling and packing the aneurysm, regardless of its shape or size.
• Coil softness combined with stretch resistance, which allows the coil to be positioned or re-positioned within the aneurysm without adding to the risk of bleeding or hemorrhagic stroke.
• Ease of coil placement through the microcatheter, providing the physician with enhanced control and deliverability.
• Rapid, safe and simple detachment of the coil through a proprietary, micro-machined and first-of-its-kind "Instantaneous Detacher" (I.D.(TM)) device that offers instantaneous coil detachment without the use of wires or syringes. This unique feature facilitates precise and rapid coil deployment while minimizing procedure time, which may be especially important in a ruptured aneurysm or when blood flow to the brain has been restricted.

A cerebral aneurysm is a weak spot in the wall of a blood vessel within the brain, characterized by an abnormal "ballooning" or widening of the vessel. It is estimated that up to one in 15 people in the United States will develop a cerebral aneurysm during their lifetime. Left untreated, cerebral aneurysms can rupture and cause stroke or death. The minimally invasive treatment of cerebral aneurysms utilizes detachable coils such as the Axium to embolize (or clot off) the aneurysm. The coiling procedure involves the delivery of platinum coils to the aneurysm via a small microcatheter. The coils are threaded through the catheter into the aneurysm until the ballooned area is completely filled while still maintaining normal blood flow through the rest of the vessel. The procedure requires a high level of precision and skill to avoid either under or over filling the aneurysm, since overfilling may cause rupture or painful pressure on adjacent tissue and under filling may permit the aneurysm to reform or grow.

Dr. Cekirge commented, "The ability to both safely and completely fill the entire aneurysm has been a critical issue in coiling, and I believe that the Axium coil represents a real advance in this area."

Dr. Saatci added, "I was also impressed by the Axium coil's softness and its smooth delivery system. In initial cases, I have been able to achieve very good conformability and aneurysm filling."

Dr. Duckwiler added, "While coiling technology has improved over the last few years, I believe that the advancements made possible with Axium will offer significant benefits to physicians, and therefore, their patients. In my experience, the new coil has met many of the performance requirements we laid out in development, including better conformability and the precision and ease of coil placement. And the new detachment system is an added bonus for instantaneous coil release, which not only speeds the procedure but eliminates the need for wires or syringes."

About ev3 Inc.

ev3 Inc. is a global medical device company focused on endovascular technologies for the minimally invasive treatment of vascular diseases and disorders.

Statements contained in this press release that are not historical information are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties include, but are not limited to, in no particular order: product demand and market acceptance, the impact of competitive products and pricing, and success of clinical testing. More detailed information on these and additional factors which could affect ev3 Inc.'s operating and financial results are described in the company's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. ev3 Inc. urges all interested parties to read these reports to gain a better understanding of the many business and other risks that the company faces. Additionally, ev3 Inc. undertakes no obligation to publicly release the results of any revision to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.

ev3 and the ev3 logo are trademarks of ev3 Inc., registered in the U.S. and other countries.

Axium is a trademark of ev3 Inc.

Source: ev3

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