Healthcare Industry News: BIOTRONIK
News Release - June 23, 2008
Micrus Endovascular Announces CE Mark for PHAROS Vitesse StentNext-Generation Stent Expands Product Offering in the Ischemic Market
SAN JOSE, Calif.--(HSMN NewsFeed)--Micrus Endovascular Corporation (Nasdaq: MEND ) today announced that its PHAROS™ Vitesse™ intracranial stent has received CE Mark authorization for commercial distribution in the European Union and all countries recognizing the CE Mark. The PHAROS Vitesse is Micrus Endovascular’s balloon-expandable stent for intracranial ischemic stenosis and wide-neck aneurysm treatment. Micrus intends to immediately begin selling the PHAROS Vitesse stent in the approved geographies through its direct sales and distribution network.
“CE Mark authorization of the PHAROS Vitesse stent supports our expansion into the large ischemic stroke market with a product that has important value-added features,” said John Kilcoyne, Chairman and CEO of Micrus Endovascular. “The PHAROS Vitesse is our second-generation stent designed with a series of technical advances for improved handling and navigability for more precise placement.”
The PHAROS Vitesse is manufactured exclusively for Micrus Endovascular through a collaborative agreement with Switzerland-based BIOTRONIK AG. It enables the intracranial delivery and deployment of a stent in one step, eliminating the need for pre-dilation of constricted vasculature. Among the PHAROS Vitesse features are a new distal tip that is longer and softer, a newly designed, thinner balloon and Micrus’ rapid exchange delivery system. Additionally, the PHAROS Vitesse incorporates a proprietary coating which the Company believes may reduce the need for retreatment due to restenosis.
Micrus Endovascular has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration to initiate a randomized, prospective clinical trial for the PHAROS Vitesse stent for the treatment of neurovascular stenoses. The IDE is currently under review.
About Micrus Endovascular Corporation
Micrus develops, manufactures and markets implantable and disposable medical devices for use in the treatment of cerebral vascular diseases. Micrus products are used by interventional neuroradiologists, interventional neurologists and neurosurgeons to treat both cerebral aneurysms responsible for hemorrhagic stroke and intracranial atherosclerosis, which may lead to ischemic stroke. Hemorrhagic and ischemic stroke are both significant causes of death and disability 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 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.
Micrus, from time to time, may discuss forward-looking information, including estimated fiscal 2009 revenues. 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 ability to obtain, and the timing of, regulatory approvals and clearances for its products, product enhancements or future products, 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 Micrus’ 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 risk factors and other disclosures in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2008, and other filings with the Securities and Exchange Commission. All forward-looking statements in this release represent the Company’s judgment as of the date of this release. The Company disclaims, however, any intention or obligation to update forward-looking statements.
Source: Micrus Endovascular
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