Healthcare Industry News: Cerecyte
News Release - November 29, 2006
Micrus Endovascular Announces Positive Results from Prospective Cerecyte Study
SAN JOSE, Calif.--(HSMN NewsFeed)--Micrus Endovascular Corporation (Nasdaq:MEND ) today announced positive initial results from a single-center study of neurovascular aneurysms treated with Micrus Endovascular's Cerecyte® microcoils indicating an excellent safety profile and a recanalization rate below historical published rates for bare platinum coils. Results from the study, authored by Martin Bendszus, MD, from the Department of Neuroradiology, University of Wurzberg, Germany, and Laszlo Solymosi, MD, were published in the November/December 2006 issue of peer-reviewed American Journal of Neuroradiology (www.ajnr.org). The article is available on the Investor Relations section of the Company's Web site at www.micruscorp.com.Cerecyte microcoils incorporate a bioactive filament with Micrus Endovascular's proprietary, three-dimensional microcoils that easily deploy within a cerebral aneurysm, forming a scaffold that conforms to a wide diversity of aneurysm shapes and sizes. Micrus believes Cerecyte will stimulate a healing response, thus improving outcomes by reducing the rate of recanalization (continued or new aneurysm growth) and the need for re-treatment.
In the prospective study, 25 aneurysms in 24 patients were treated with Cerecyte microcoils. The primary goal of the study was to assess safety of Cerecyte microcoils in terms of periprocedural, technical or angiographic complications. The secondary goal was to evaluate treatment efficacy based on primary occlusion, packing attenuation and recanalization at follow-up angiography six months after treatment. There were no major technical or angiographic complications resulting in permanent morbidity, which is similar to other study results using traditional bare platinum microcoils. Complete initial occlusion of the aneurysm was accomplished in 17 patients (68%) and a neck remnant was present in eight patients (32%). At the six-month follow up the occlusion rate of the treated aneurysms had improved to 88% with a residual neck remnant of only 12%.
Preliminary study data indicate a recanalization rate of 12%, compared with the historical rate of 17% to 33% with bare platinum coils. The study authors contend that the promising low recanalization rate warrants a larger randomized, controlled clinical trial. Preliminary data further suggest that handling of the Cerecyte microcoils was comparable to handling of bare platinum coils.
"While based on a small study group, initial results are important as recanalization is an ongoing issue with endovascular coiling. The recanalization rate with Cerecyte microcoils in this study compared well with historical study results using bare metal coils, as well as with recent study results using a competitors microcoils in which a bioactive ingredient is coated on the outside of the microcoil," said John Kilcoyne, Micrus Endovascular president and CEO. "Further, the study indicates that our Cerecyte microcoils have the same ease of handling characteristics found in bare platinum coils."
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 increased adoption of embolic coiling as a procedure to treat cerebral aneurysms, the Company's limited operating history and history of significant operating losses, the Company's involvement in patent litigation with Boston Scientific Corporation, fluctuations in quarterly operating results, which are difficult to predict, the Company's dependence on developing new products or product enhancements, challenges associated with rapid growth, 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, the Company's dependence on obtaining timely FDA as well as applicable international regulatory clearances and approvals for our future products or product enhancements, 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 and 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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