Landmark Randomized Trial Shows Exceptional Clinical Outcomes for Micrus Endovascular Corporation (MEND) Microcoils
5/21/2010 8:42:05 AM
SAN JOSE, Calif.--(BUSINESS WIRE)--Micrus Endovascular Corporation (NASDAQ:MEND - News) announces that preliminary six-month follow-up data from the Cerecyte Coil Trial (CCT) show exceptionally strong clinical outcomes for both Micrus Endovascular Cerecyte® and bare platinum microcoils in the treatment of cerebral aneurysms. The data were presented by CCT principal investigator Andrew Molyneux, M.D., FRCR, Oxford Neurovascular & Neuroradiology Research Unit, University of Oxford, U.K., at the 48th Annual American Society of Neuroradiology meeting in Boston.
The CCT trial is a prospective, randomized, multicenter clinical trial designed to show the superiority of polymer-filled Cerecyte microcoils and compare clinical outcomes and safety for patients with ruptured and un-ruptured cerebral aneurysms treated with either Micrus Cerecyte microcoils or with Micrus bare platinum microcoils. Of the 500 patients recruited at 23 centers worldwide, 249 were randomized to the Micrus Cerecyte arm and 251 to the bare platinum arm. Data on 444 patients were presented by Dr. Molyneux.
Key Preliminary CCT Results
Dr. Molyneux presented preliminary CCT outcomes utilizing the modified Rankin Scale (mRS) for freedom from disability or dependence, or mRS =2. The mRS is a commonly used six-point scale for measuring the degree of disability or dependence in the daily activities of people who have had a stroke, and is the most widely used clinical outcome measure for stroke clinical trials. He also presented investigator-reported angiographic occlusion rates. Key results are as follows:
“The preliminary CCT data are indeed impressive, and I found the preliminary mRS results to be spectacular,” said Richard Kerr, M.D., FRCS and a member of the CCT Independent Data Monitoring and Safety Board.
Dr. Molyneux said, “CCT is a landmark study that demonstrates positive preliminary efficacy and safety rates for both Micrus Cerecyte and Micrus bare platinum coils as reflected in the exceptional clinical outcomes and low rates of re-intervention. The interim data demonstrate that, based on the core lab assessment of angiographic success, the Cerecyte and Micrus bare platinum groups are superior to those of the ISAT study and that the safety outcomes for Micrus Cerecyte and Micrus bare platinum coils are superior to the coiling results reported in the ISAT study, as well as all other published or presented randomized data. Additionally, because of the strength of Micrus bare platinum results, the clinical outcomes between the bare platinum and Cerecyte arms of the CCT were statistically equivalent.”
The CCT trial design includes independent angiographic core lab assessment by Allan Fox, M.D., Sunnybrook HSC, Toronto, Canada, and adjudication of adverse events by medical reviewers blinded to the treatment modality utilized. The independent angiographic core laboratory assessment and adjudication are not yet complete. Dr. Molyneux expects to submit final, full CCT trial data for publication in a peer-reviewed journal later this year.
CCT Results Compared with ISAT
Drs. Molyneux and Kerr were lead investigators of the only randomized, controlled trial in interventional neuroradiology published to date: the International Subarachnoid Aneurysm Trial (ISAT). Published in 2002, that multicenter, prospective clinical trial included 1,063 coiled patients with ruptured aneurysms only, and concluded that endovascular coiling produced superior clinical outcomes compared with surgical clipping of the aneurysms.
Six-month preliminary data from CCT for patients with ruptured aneurysms (n=228) compared with 12-month data from ISAT (n=1,063) are as follows:
“Outcomes, occlusion rates and retreatment rates of procedures performed with Micrus microcoils – whether Cerecyte or bare platinum – are far superior to the seminal ISAT results, and we expect that interventionalists around the world will appreciate the outstanding clinical outcomes that Micrus coils deliver,” said John Kilcoyne, Chairman and CEO of Micrus Endovascular. “The CCT results further validate our established role as a leader in endovascular microcoil technology, and support the ongoing conversion to Micrus coils. We also believe these data may accelerate the conversion from surgical intervention to minimally invasive coiling in patients with cerebral aneurysms.”
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 endovascularly trained 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 anatomically deploy within the aneurysm, forming a scaffold that conforms to a wide diversity of aneurysm shapes and sizes. Micrus also sells stents, balloon catheters, access devices such as guide catheters, microcatheters, guidewires and accessory 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 the final results of the CCT trial and market response to the CCT results. 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, continued growth in embolic coiling procedures and market acceptance of our products and other risks affecting the Company, including the current worldwide economic conditions, 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, 2009, as well as in its 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.
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