Healthcare Industry News: cryoablation
News Release - August 27, 2007
CryoCor Completes Enrollment of Pivotal Clinical Study for Atrial FibrillationSAN DIEGO, Aug. 27 (HSMN NewsFeed) -- CryoCor, Inc. (Nasdaq: CRYO ), a medical device company focused on the treatment of cardiac arrhythmias, announced today the completion of enrollment of its pivotal clinical study for the treatment of atrial fibrillation.
Ed Brennan, Ph.D. Chief Executive Officer of CryoCor, said, "This is a major milestone for CryoCor, being the first company to complete enrollment in a randomized pivotal study for the use of ablation for the treatment of atrial fibrillation. Completion of enrollment confirms our lead over other companies conducting atrial fibrillation ablation pivotal trials and brings us one step closer to our goal of bringing our product to market for the treatment of atrial fibrillation. With the recent approval of our cryoablation system for the treatment of right atrial flutter, in the fourth quarter, we will begin placing our system at high volume ablation centers across the U.S., familiarizing physicians with our system and establishing our installed base of consoles in anticipation of approval for the treatment of atrial fibrillation in 2009."
Helen Barold, M.D. Chief Medical Officer of CryoCor, said, "I am very pleased with the progress we have made with this study and look forward to fully analyzing the data. We continue to see an excellent safety profile for our cryoablation device and expect to file a PMA in late 2008. At this point we will begin our non-randomized continued access protocol in which patients will be enrolled into the ablation arm. "
CryoCor has enrolled over 170 patients in its pivotal clinical study and will complete a 12-month follow up for each patient.
CryoCor is a medical technology company that has developed and manufactures a disposable catheter system based on its proprietary cryoablation technology for the minimally invasive treatment of cardiac arrhythmias. The Company's product, the CryoCor Cardiac cryoablation System, or the cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. The cryoablation System has been approved in Europe for the treatment of atrial fibrillation, and atrial flutter, the two most common and difficult to treat arrhythmias, since 2002. In the United States, CryoCor is conducting a pivotal trial to evaluate the safety and efficacy of the cryoablation System for the treatment of atrial fibrillation and the cryoablation System has been approved for the treatment of right atrial flutter. For more information please visit the Company's website at http://www.cryocor.com
Forward Looking Statements
The statements in this press release that are not descriptions of historical facts are forward-looking statements that are subject to risks and uncertainties. These include statements related to the Company's lead time over other companies conducting atrial fibrillation ablation pivotal trials, ability of obtain FDA approval for and commercialize its product for the treatment of atrial fibrillation and its timing for doing so, including its timing for the filing the related PMA, and ability to, and the benefits from, placing its systems in high volume ablation centers in the U.S., all of which are prospective. Such statements are only predictions and reflect CryoCor's expectations and assumptions as of the date of this press release based on currently available operating, financial, and competitive information. The actual events or results may differ materially from those projected in such forward-looking statements due to a number of factors, including risks involved with CryoCor's ability to obtain regulatory approval in the United States for its cryoablation system for use in treating atrial fibrillation within its anticipated timeframes, if at all; risks associated with the Company's ability to submit a PMA for atrial fibrillation; risks associated with the Company's ability to receive approval from the FDA for the use of its cryoablation system to treat atrial fibrillation; risks associated with the Company's ability to successfully commercialize its cryoablation system in the United States and elsewhere if its cryoablation system is approved for use in the United States; risks associated with the Company's dependence on patents and proprietary rights; risks associated with the Company's protection and enforcement of its patents and proprietary rights; risks associated with the development or availability of competitive products or technologies; risks associated with the Company's ability to maintain and achieve milestones under collaborative agreements and the other risks and uncertainties identified in the Company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. The Company expressly disclaims any intent or obligation to update any of these forward- looking statements.
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