Healthcare Industry News: steerable catheter
News Release - May 29, 2007
Micrus Endovascular Receives FDA Clearance for the ENZO Steerable Microcatheter
SAN JOSE, Calif.--(HSMN NewsFeed)--Micrus Endovascular Corporation (Nasdaq:MEND ) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ENZO(TM) steerable microcatheter. The ENZO steerable catheter is designed to offer improved maneuverability through the brain's tortuous vasculature and to enable in vivo repositioning of the microcatheter in the aneurysm, allowing physicians to more efficiently fill aneurysms, which may lead to improved outcomes. ENZO is the only steerable microcatheter available for use in the neurointerventional market."We believe the ENZO's proprietary steering capability will provide unmatched speed and access to cerebral aneurysms, making this a frontline choice for the approximately 60,000 coiling procedures performed annually worldwide," said John Kilcoyne, Micrus Endovascular president and CEO. "Introducing the ENZO supports our strategy to deliver clinically significant solutions for the neurointerventional market. We believe that the novel and proprietary design of the ENZO microcatheter will provide us with a brand new access point to physicians who may not currently be Micrus coil, catheter, wire or stent customers.
"We will conduct our standard controlled launch for evaluation prior to our anticipated worldwide introduction of the ENZO," he added. "We also plan to investigate the opportunity of licensing this technology for applications outside of the neurointerventional market."
Micrus Endovascular designed and developed the ENZO steerable catheter based on intellectual property gained through its technology acquisition from VascularFX in July 2005. The catheter will be manufactured at Micrus Design Technology, Inc.
About Micrus Endovascular Corporation
Micrus develops, manufactures and markets both implantable and disposable medical devices used in the treatment of cerebral vascular diseases. Micrus products are used by interventional neuroradiologists and neurosurgeons primarily to treat cerebral aneurysms responsible for hemorrhagic stroke, a significant cause of death worldwide. The Micrus product line enables physicians to gain access to the brain in a minimally invasive manner through the vessels of the circulatory system. Micrus' proprietary, three-dimensional microcoils are unique in that they automatically deploy within the aneurysm, forming a scaffold that conforms to a wide diversity of aneurysm shapes and sizes. Micrus also sells accessory devices and products used in conjunction with its microcoils. For more information, visit www.micruscorp.com.
Forward-Looking Statements
Micrus, from time to time, may discuss forward-looking information. Except for the historical information contained in this release, all forward-looking statements are predictions by the Company's management and are subject to various risks and uncertainties that may cause results to differ from management's current expectations. Such factors include the Company's dependence upon the continued growth in embolic coiling as a procedure to treat cerebral aneurysms, the Company's involvement in patent litigation with Boston Scientific Corporation, the Company's limited operating history and history of significant operating losses, fluctuations in quarterly operating results, which are difficult to predict, the Company's dependence on developing new products or product enhancements, challenges associated with complying with applicable state, federal and international regulations related to sales of medical devices and governing our relationships with physicians and other consultants, the Company's ability to compete with large, well-established medical device manufacturers with significant resources and other risks as detailed from time to time in the Company's final prospectus dated July 13, 2006 and reports and filings with the Securities and Exchange Commission under the Securities Exchange Act of 1934. All forward-looking statements in this release represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update forward-looking statements.
Source: Micrus Endovascular
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