MTIX Micro Therapeutics (MM)

ev3 Announces Enrollment Has Begun for SpideRX(TM) Embolic Protection Device in Second Phase of Carotid Clinical Trial PLYMOUTH, Minn., March 21 /PRNewswire/ -- ev3 Inc., a privately held endovascular medical device company, has received approval to include the SpideRX(TM) Embolic Protection Device in the second arm of the company's Carotid Clinical Trial. Embolic protection devices are small filters placed within a blood vessel to capture and remove plaque particles dislodged during interventional procedures, such as angioplasty or stenting, to prevent stroke or heart attack. ev3 has completed enrollment in the first phase of this trial using the SPIDER(TM) Embolic Device and the Protege(R) GPS(TM) Self-Expanding Stent. The 30-day results of the first phase will be presented in a late- breaking trials session at the Society of Interventional Radiologists meeting on April 3, in New Orleans. The second phase of the trial will evaluate the SpideRX Device when used with the approved and commercially available GUIDANT RX ACCULINK(TM) Carotid Stent System. The trial is called CREATE (carotid revascularization with ev3 arterial technology evolution). "We believe this trial will provide our investigators with the opportunity to gain important clinical experience with our rapid exchange embolic protection system and the already available GUIDANT RX ACCULINK Carotid Stent System," stated Ginny Kirby, vice president of clinical affairs at ev3. "This will demonstrate the SpideRX Device compatibility with both the Protege and the GUIDANT RX ACCULINK Carotid Stent System." The SpideRX Device, like its predecessor product, has a unique nitinol filter. (Nitinol is an alloy commonly used in interventional products.) The new device is designed to provide more efficient delivery, capture and recovery, while still allowing interventionalists to use their interventional wire of choice. Improvements over the current device include a complete rapid exchange system, 6 Fr. guide catheter compatibility and a unique dual-end delivery/recovery catheter with a pre-loaded capture wire. Dr. Robert Safian, William Beaumont Hospital, Royal Oak, Mich., and Dr. Gary Ansel, Riverside Hospital, Columbus, Ohio, are national Co-Principal Investigators for the CREATE Trial. Dr. Safian stated, "The SPIDER Embolic Protection Device, which we studied in the CREATE Trial, is a unique distal embolic protection device that has several advantages over other protection devices, especially with regard to its ease of use and reliable delivery. The SpideRX Device is even easier to use by allowing the operator to use a rapid exchange delivery system." The SpideRX Device is currently commercially available in Europe and several countries in Latin America and Asia. Carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. When narrowing occurs, patients are at risk for stroke. According to the American Heart Association, more than 700,000 Americans have strokes each year, with an estimated 164,000 resulting in death. About ev3 ev3 Inc., privately held and based in Plymouth, Minnesota, was founded in 2000. ev3 Inc. is a global medical device company that is focused on innovative endovascular technologies for the minimally invasive treatment of coronary, neurovascular, and peripheral vascular diseases and disorders. In 2001, ev3 established a strategic relationship with Micro Therapeutics, Inc. (NASDAQ:MTIX), a leader in the market for catheter-based neurovascular devices. ev3 Inc. and Micro Therapeutics, Inc., are majority owned by ev3 LLC, a private equity partnership organized by Warburg Pincus and the Vertical Group, two of the most successful institutional investors in the medical device industry. More information about ev3 and its products can be found at http://www.ev3.net/ . ** The SPIDER(TM) and SpideRX(TM) Embolic Protection devices are investigational devices limited by federal (U.S.) law to investigational use in the United States. The SPIDER and SpideRX(TM) and Devices are not available for sale in the United States. SPIDER, SpideRX and ev3 are trademarks of ev3 Inc. ACCULINK is a trademark of GUIDANT Corporation GUIDANT is a registered trademark of GUIDANT Corporation DATASOURCE: ev3 Inc. CONTACT: Tom Timbie, CFO of ev3 Inc., +1-763-398-7000, ; or, Marian Briggs, +1-612-455-1742, , Laura Spitzack, +1-612-455-1782, , both of Padilla Speer Beardsley Web site: http://www.ev3.net/

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