Micro Therapeutics Completes First EMBOLYX Procedure in the U.S.; AVM Case at UCLA a Success.SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Jan. 20, 1998--Micro Therapeutics Inc. (Nasdaq:MTIX MTIX Moving Target Information Exploitation MTIX Moving Target Indicator Exploitation MTIX MetroTix, Inc. (Saint Louis, MO, USA) ) (MTI MTI Ministry of Trade and Industry (Singapore) MTI Metal Treating Institute MTI Moving Target Indicator (radar) MTI Magyar Távirati Iroda (news agency in Budapest, Hungary) ), a developer of novel therapeutic devices to treat neurovascular and peripheral vascular diseases, Tuesday announced the first treatment in the United States of an arteriovenous malformation (AVM AVM 1 Acute viral meningitis, see there 2 Arteriovenous malformation, see there ) in the brain using the company's proprietary EMBOLYX Liquid Embolyx System. The first case in the study, performed at UCLA UCLA University of California at Los Angeles UCLA University Center for Learning Assistance (Illinois State University) UCLA University of Carrollton, TX and Lower Addison, TX School of Medicine, involved the treatment of an AVM located in a highly sensitive area of the brain involving control of muscle function. The procedure was judged to be successful in that the size of the AVM was significantly reduced and the patient allowed to proceed to further treatment by non-invasive radiosurgery radiosurgery /ra·dio·sur·gery/ (-ser´jer-e) surgery in which tissue destruction is performed by means of ionizing radiation rather than by surgical incision. . Sponsored by UCLA, the 10-patient study is being conducted under the guidance of Fernando Vinuela, M.D., director, interventional neuroradiology, Department of Radiological Sciences at UCLA School of Medicine, and will evaluate the safety and efficacy of embolization embolization /em·bo·li·za·tion/ (em?bo-li-za´shun) 1. the process or condition of becoming an embolus. 2. therapeutic introduction of a substance into a vessel in order to occlude it. with EMBOLYX for the preoperative or permanent treatment of brain AVMs. MTI is preparing its own investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) application to obtain clearance from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to initiate an expanded U.S. clinical trial later this year. "We are pleased with the successful initiation of the clinical study at UCLA for our EMBOLYX material and that the first case demonstrated a safety profile comparable to similar studies ongoing outside of the country," said George Wallace, president and chief executive officer of MTI. "To date, EMBOLYX has been evaluated in more than 18 AVM patients and could become a powerful treatment option for vascular disorders associated with stroke including aneurysms, which will be studied later this year." EMBOLYX is under development for the endovascular treatment of AVMs and aneurysms in the brain. In an AVM, the flow of blood between arteries and veins, which normally occurs through capillary vessels, is short-cut by the development of larger vessels connecting directly from arteries to veins. The higher pressure on the arterial side makes these vessels highly prone to rupture, which can lead to stroke. For the interventional treatment of AVMs, the EMBOLYX material is delivered via micro catheters that allow access to small, remote blood vessels in the brain. Once deployed into the desired site, it quickly transforms into a solid polymer mass to fill the AVM. Micro Therapeutics, founded in 1993 and based in San Clemente, develops, manufactures and markets minimally invasive medical devices for the diagnosis and treatment of vascular disease. -0- Certain statements in this release are forward-looking and may involve risk and uncertainties, including, but not limited to, product development, demand and market acceptance risks, the impact of competitive products and pricing, and future product development. More information on factors which could affect Micro Therapeutic Inc.'s financial results is included in the company's prospectus dated Feb. 18, 1997, filed with the Securities and Exchange Commission. CONTACT: Micro Therapeutics Inc., San Clemente Harold A. Hurwitz, 714/361-0616 or Pondel Parsons & Wilkinson, Los Angeles Rob Whetstone whetstone, natural or manufactured stone used as an abrasive solid to sharpen tools. It is used dry, with water, or with oil. Such a stone of the finer grade used with oil is usually called an oilstone. , 310/207-9300 |
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