Health & Fitness
Health and Fitness
Health and Fitness
Wed, February 11, 2009
Micrus Endovascular Initiates VISSIT Trial with Pharos Vitesse Balloon Expandable Stent
SAN JOSE, Calif.--([ BUSINESS WIRE ])--Micrus Endovascular Corporation (Nasdaq:MEND) today announced it has enrolled the first patient in the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT), an investigational device exemption (IDE) study designed to compare clinical outcomes between patients treated with the Company's Pharos™ Vitesse™ Balloon Expandable Stent and the current best medical practice. The patient was treated by Dr. Monika Killer-Oberpfalzer, the Principal Investigator for the VISSIT Study at the Neuroscience Institut Salzburg of the Paracelsus Medical University in Salzburg, Austria.
The VISSIT clinical trial is designed to include up to 250 patients who demonstrate ischemic symptoms attributable to stenosis of an intracranial artery. The trial will be conducted at a total of 30 sites in the U.S., Europe and China. Trial completion is anticipated in approximately 30 months, with full enrollment expected between 12 months and 15 months and each patient evaluated during a 12-month post-treatment follow-up period.
"The VISSIT trial is primarily designed to evaluate the safety, probable benefit, and effectiveness of the Pharos Vitesse and has a secondary objective of evaluating the impact of stenting in the neurovasculature to treat cerebral ischemia on other outcomes, such as hospital length of stay and costs," said John Kilcoyne, Chairman and CEO of Micrus Endovascular. "This is the first global, industry-sponsored prospective, randomized clinical trial to evaluate the safety and effectiveness of an intracranial stent for stenoses caused by intracranial atherosclerotic disease, which are responsible for 8% to 10% of all strokes.
"Our 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 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 longer rapid exchange length, which the Company believes will further enhance tracking and crossing capabilities of the Vitesse stent system. The Pharos Vitesse is manufactured exclusively for Micrus Endovascular through a collaborative agreement with Switzerland-based Biotronik AG.
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 lines enable physicians to gain access to the brain in a minimally invasive manner through the vessels of the arterial 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 stents, access devices such as guide catheters, microcatheters and accessory 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, 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 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 limited operating history and history of significant operating losses, fluctuations in quarterly operating results, which are difficult to predict, currency exchange rate fluctuations, 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.
