Healthcare Industry News: neuroradiology
News Release - June 5, 2008
Positive Clinical Data Evaluating the Micrus Endovascular Cerecyte Microcoil Published in Peer-Reviewed JournalsSAN JOSE, Calif.--(HSMN NewsFeed)--Micrus Endovascular Corporation (Nasdaq: MEND ) today announced that positive data from two clinical studies evaluating the use of the Micrus Endovascular Cerecyte® bioactive microcoil in the treatment of cerebral aneurysms have been published in peer-reviewed scientific journals. Cerecyte platinum microcoils contain a polyglycolic acid filament that researchers suggest may accelerate the healing process.
“We are pleased that data from both clinical studies show an aneurysm recurrence rate with Cerecyte bioactive microcoils of approximately 11% and a retreatment rate of approximately 6%, which is significantly lower than the rate reported with use of bare-platinum and competitive bioactive coils. These results continue to confirm our belief that our Cerecyte bioactive microcoils may lead to improved outcomes when compared with bare platinum coils,” said John Kilcoyne, Chairman and CEO of Micrus Endovascular.
In the first article “Initial Experience with Bioactive Cerecyte Detachable Coils: Impact on Reducing Recurrence Rates” published in the April edition of Neurosurgery, researchers evaluated 81 patients with 89 aneurysms treated exclusively with Cerecyte bioactive microcoils for safety, durability and effect on recanalization rates. Of the 89 aneurysms, 65% were ruptured and the mean aneurysm size was 7 mm. Follow-up angiography at a mean of 11.2 months demonstrated a total recurrence rate of 10.7% and recurrences requiring retreatment of 6.7%.
“The Cerecyte bioactive coil seems safe and effective for use in both ruptured and unruptured aneurysms and the fact that the bioactive polymer is located within the coil makes for handling characteristics similar to those of bare platinum coils,” commented the study’s lead investigator Erol Veznedaroglu, M.D., of the Thomas Jefferson University Department of Neurological Surgery, Philadelphia, Penn. “Based on the results of this study, we believe further studies to assess long-term outcomes of the Cerecyte bioactive coils, with direct comparison to platinum coils and alternative bioactive coils, are now warranted.”
In the second article “Endovascular Treatment of Intracranial Aneurysms with Bioactive Cerecyte Coils: Effects on Treatment Stability” published in the May 2008 edition of neuroradiology, researchers evaluated mid-term angiographic follow-up data to assess Cerecyte bioactive microcoils’ durability and efficacy in preventing recanalization. The results were based on 78 patients with 84 intracranial aneurysms treated exclusively with Cerecyte bioactive coils. Of those 78 aneurysms, 48 were ruptured and 36 were incidental; 77 were small (<10 mm), six were large (10-25 mm) and one was giant (>25 mm). Follow-up angiography was obtained in 80 aneurysms over a six-month to two-year time period, with an overall recanalization rate of 11.3%. Procedure-related morbidity and mortality rates were 2.6% and 1.3%, respectively.
“Cerecyte coils represent a new technology that potentially can offer improved outcomes compared to bare platinum coils,” commented study investigator Saruhan Cekirge, M.D., of Hacettepe University Hospital’s Department of Radiology Interventional Neurology Unit, Ankara, Turkey. “Although our results provided an improved initial treatment success with relatively low complication and recurrence rates compared to those reported for bare-platinum coils, the effectiveness of Cerecyte bioactive coils in preventing aneurysm recurrence remains to be proven by the ongoing controlled, multicenter, randomized Cerecyte trial that is gathering information regarding the safety of the procedure, as well as the efficacy of the treatment including the aneurysm recurrence and retreatment rates after treatment with Cerecyte coils versus bare platinum coils.”
“The dissemination of these clinical results in respected scientific journals serves as an important source of information for neurointerventionalists performing minimally invasive coiling procedures,” said John Kilcoyne, Chairman and CEO of Micrus Endovascular. “We look forward to more Cerecyte clinical data and publications from individual clinical series as well as the results from our 500-patient Cerecyte prospective, randomized trial led by University of Oxford neurologist Dr. Andrew J. Molyneux. With the recent addition of several high-volume U.S. clinical sites, we now believe enrollment in this study comparing Cerecyte bioactive coils to bare platinum coils will be completed this calendar year resulting in a potential submission of clinical study results to a peer-reviewed journal in the latter half of 2009.”
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, 2007, 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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