Micrus Endovascular Receives FDA Approval For Intracranial Stent Clinical Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Jul 2008 - 0:00 PDT

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Micrus Endovascular Corporation (Nasdaq:MEND) announced that the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) clinical trial application has been conditionally approved by the U.S. Food and Drug Administration (FDA). The Pharos™ Vitesse™ intracranial stent is Micrus Endovascular's second balloon-expandable stent for the treatment of intracranial ischemic stenosis and is the subject of an investigational device exemption (IDE) study designed to compare the clinical outcomes between patients treated with the stent and another medical therapy. The Company is in the process of initiating study sites in the United States, Europe and China.

"We are pleased to obtain IDE approval for VISSIT and proud to support the first global, industry-sponsored prospective, randomized clinical trial to evaluate the safety and effectiveness of an intracranial stent for this significant medical condition," said John Kilcoyne, Chairman and CEO of Micrus Endovascular. "Our second-generation Pharos Vitesse stent is designed with a series of technical advances for improved handling and navigability and also incorporates a proprietary coating that we believe may reduce the need for retreatment due to restenosis."

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.

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 http://www.micruscorp.com.

Forward-Looking Statements

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 risk of inconclusive or unfavorable clinical trial results, the uncertain market for balloon-expandable stents to treat intracranial stenoses, , the Company's ability to obtain, and the timing of, regulatory approvals and clearances for its products, product enhancements or future products, and other risks affecting the Company, including 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.

Micrus Endovascular Corporation