MTIX Micro Therapeutics (MM)

ev3(TM) Receives 510(k) Marketing Clearance for X-SIZER(R) Thrombectomy Catheter System for Dialysis Graft Use System Mechanically Clears Blood Clots Quickly and Reliably PLYMOUTH, Minn., Sept. 21 /PRNewswire/ -- ev3(TM) Inc., a privately held endovascular medical device company, has received 510(k) marketing clearance from the Food and Drug Administration (FDA) for the use of the company's X-SIZER(R) Thrombectomy Catheter System to mechanically remove thrombus (blood clots) in synthetic vessel grafts in hemodialysis patients. The X-SIZER Thrombectomy Catheter uses a helical cutter and vacuum to engage, shear and remove blood thrombus from the graft without trauma. "The X-SIZER Thrombectomy System is an important addition to ev3's technologies in the U.S. market," said James Corbett, ev3 president and chief executive officer. "This device has been available for blood clot removal in coronary arteries and saphenous vein grafts for several years in Europe and other parts of the world. The effectiveness and convenience of the X-SIZER System will be a welcome option for physicians in dialysis graft cases." Hemodialysis, a procedure to remove metabolic wastes from the blood for treating kidney failure, requires reliable long-term access to the patient's blood vessels. In the United States, access is frequently accomplished with a synthetic graft in the forearm that connects the brachial artery to the brachial or cephalic vein. Over time, grafts can become narrowed by development of abnormal vessel tissue growth or fibrosis, which can cause a clot to form that blocks blood flow through the graft. Clot-dissolving drugs injected into the graft are one treatment option. However, safety and efficacy concerns recently prompted FDA limitations on some drugs. As a result, use of some thrombolytic agents has declined, and more physicians are turning to catheter devices to mechanically clear the thrombus from the graft site. Further, mechanical thrombus removal generally provides more immediate results than drugs. After thrombus removal, balloon angioplasty is often performed to reopen the access graft. About the X-SIZER Thrombectomy Catheter System The X-SIZER System includes the thrombectomy catheter with a helical cutter, a battery-powered control unit to operate the cutter and a vacuum bottle to remove thrombus through the catheter lumen. As a fully contained device, the ev3 system eliminates the need for large control consoles or power supplies common with other mechanical thrombus removal systems. Fast and easy device prep allows one person to set up the system in less than two minutes. The physician can place the catheter in the graft site using any standard 300cm, 0.014" guide wire, and use the same guide wire for both thrombectomy and balloon angioplasty, speeding the procedure. All the components necessary to perform the thrombectomy are provided with each device. The X-SIZER Catheter has had CE Mark Approval for use in native coronary vessels and saphenous vein grafts in Europe since 2002, and now has FDA 510(k) market clearance for mechanical thrombus removal in synthetic dialysis grafts in the United States. About ev3 ev3 Inc., privately held and based in Plymouth, Minnesota, 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(TM), 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/ . ev3, Protege, Protege GPS, SPIDER, SpideRX, X-SIZER, PLAATO, IntraCoil, ParaMount, IntraStent, AqWire, Nitrex and Goose Neck are trademarks of ev3 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 Web site: http://www.ev3.net/

Copyright