Healthcare Industry News: cryoablation
News Release - February 15, 2007
CryoCor PMA to be Reviewed at FDA PanelSAN DIEGO, Feb. 15 (HSMN NewsFeed) -- CryoCor, Inc. (Nasdaq: CRYO ), a medical device company focused on the treatment of cardiac arrhythmias, announced today that it has been informed by the U.S. Food and Drug Administration, or FDA, that an Advisory Panel meeting will be convened to review CryoCor's pre-market approval application, or PMA, for the treatment of atrial flutter. The Advisory Panel will be comprised of medical experts who will advise the FDA in its evaluation of the chronic effectiveness of CryoCor's device for the treatment of atrial flutter. The date for the panel review of the clinical data on CryoCor's medical device is expected to be in early April 2007.
Helen S. Barold, M.D., Chief Medical Officer of CryoCor said, "We are very pleased with the FDA's decision to convene an Advisory Panel meeting to review our PMA filing. We believe that our clinical data demonstrate sufficient safety and effectiveness to warrant marketing approval, and we will ask important clinical investigators and key opinion leaders to join us in presenting our data to the FDA's panel."
The Company reported that several physicians are expected to present on its behalf at the panel meeting, including Dr. Hugh Calkins, Director of Electrophysiology at Johns Hopkins University and Professor of Medicine at Johns Hopkins University School of Medicine; Dr. James P. Daubert, Associate Professor of Medicine at University of Rochester School of Medicine; Dr. Gregory K. Feld, Professor of Medicine at University of California, San Diego; Melvin M. Scheinman, M.D., Professor of Medicine Emeritus, Walter H. Shorenstein Endowed Chair in Cardiology at the University of California, San Francisco; Dr. Albert L. Waldo, Walter H. Pritchard Professor Case Western Reserve University, Associate Chief of Cardiology for Academic Affairs and Dr. Hein Wellens, Chairman of the Department of Cardiology at University Hospital Maastricht.
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, or AF, and atrial flutter, or AFL, 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 AF, and has submitted a PMA for the treatment of AFL. 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 included in this press release related to CryoCor's amendment to its PMA for AFL including the expected time period for the FDA's review of that amendment and the possibility of receiving approval for the treatment for AFL, all of which are prospective. Such statements are only predictions and reflect the Company'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 the CryoCor's ability to obtain regulatory approval in the United States for its Cardiac cryoablation System for use in treating AFL and AF within its anticipated timeframes, if at all; risks associated with the Company's ability to successfully commercialize its Cardiac cryoablation System in the United States and elsewhere if its Cardiac 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; 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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