MTIX Micro Therapeutics (MM)

ev3 Receives Investigational Device Exemption for Use of SpideRX(TM) Embolic Protection Device in Clinical Trial PLYMOUTH, Minn., Dec. 6 /PRNewswire/ -- ev3(R) Inc., a privately held endovascular medical device company, has received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration for the company's SpideRX(TM) Embolic Protection Device for inclusion in the ongoing SPIDER Saphenous Vein Graft Clinical Trial. The company plans to introduce the next-generation rapid exchange SpideRX Device into the trial immediately. 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. "This is a significant addition to our ongoing trial," stated Ginny Kirby, ev3 vice president of clinical affairs. "We believe including the SpideRX Device will provide our investigators with the opportunity to gain important clinical experience with leading edge technology as they work with us to demonstrate the overall safety and effectiveness of our embolic protection system." The new SpideRX 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. Like its predecessor product, the SpideRX Device has a unique nitinol filter. (Nitinol is an alloy commonly used in interventional products.) Dr. William O'Neill, principal investigator for the SPIDER Trial of William Beaumont Hospital, added, "The SpideRX Device, without question, will become the dominant distal protection device once it is cleared. It provides all the advantages of the SPIDER(TM) Device, including the ability to use standard wires to access the distal vessel, as well as the flexibility of the distal filter. In addition, the RX design will dramatically simplify the procedure and decrease procedure time. The operators will be able to perform distal protection with a single operator approach that fits easily into the modern cath. lab environment." The purpose of the trial is to establish the safety and efficacy of this embolic protection device in patients who have a significant narrowing of a saphenous vein graft. This clinical trial includes 80 centers and will enroll over 1,000 patients. ev3 received CE Mark approval for the SpideRX Device in June 2004. The product is commercially available in Europe and several countries in Latin America and Asia. About ev3 ev3 Inc., privately held and based in Plymouth, Minn., was founded in 2001. 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) Embolic Protection device is an investigational device limited by federal (U.S.) law to investigational use in the United States. For carotid use, the Protege(R) GPS(TM) Stent is limited by federal (U.S.) law as "investigational only" in the United States. The SpideRX(TM) and Protege(R) GPS(TM) Tapered Devices are not available in the United States. ev3, Protege, Protege GPS, SPIDER, SpideRX, X-SIZER, PLAATO, IntraCoil, ParaMount, IntraStent, AqWire, Nitrex and Goose Neck are trademarks of ev3(R) Inc. Micro Therapeutics, Sapphire, Onyx, and Echelon are trademarks of Micro Therapeutics, Inc. DATASOURCE: ev3 Inc. CONTACT: Cheryl Newell, CFO of ev3, Inc., +1-763-398-7000, ; or Nancy A. Johnson, +1-612-455-1745, , or Marian Briggs, +1-612-455-1742, , both of Padilla Speer Beardsley for ev3 Inc. Web site: http://www.ev3.net/

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