Healthcare Industry News: Cardiac Ablation
News Release - March 22, 2007
Cardima PMA for Treatment of Atrial Fibrillation Symptoms to Be Reviewed by FDA Dispute Resolution Panel
FREMONT, CA--(Healthcare Sales & Marketing Network)--Mar 22, 2007 -- Cardima, Inc. (OTC BB:CRDM.OB ), a medical device company focused on the treatment of atrial fibrillation, announced today that the U.S. Food and Drug Administration (FDA) will convene a dispute resolution panel on April 19, 2007 to consider the approvability of Cardima's pre-market approval application (PMA) for the REVELATION® Tx Microcatheter System for the treatment of symptoms associated with atrial fibrillation. The Medical Device Dispute Resolution Panel (MDDRP) will be comprised of medical experts who will advise the FDA in its evaluation of the safety and effectiveness of the REVELATION® Tx Microcatheter System.Gabe Vegh, Chief Executive Officer of Cardima, said, "We are pleased to have this opportunity to openly discuss the scientific issues with a panel of experts who are familiar with the rapidly evolving field of atrial fibrillation, and we are hopeful that the experts can help resolve the dispute regarding our PMA. We believe that our clinical data demonstrate sufficient safety and effectiveness to warrant marketing approval, and we are thankful to the experts who have agreed to assist us in presenting our data to the panel."
About Cardima
Cardima, Inc. has developed the REVELATION® Tx, REVELATION® T-Flex and REVELATION® Helix linear ablation microcatheters, the NAVIPORT® deflectable guiding catheters, and the INTELLITEMP® energy management system for the minimally invasive treatment of atrial fibrillation. The REVELATION® Tx, REVELATION® T-Flex and REVELATION® Helix systems and the INTELLITEMP® have received CE Mark approval in Europe. The Company has also developed and obtained marketing clearance in the USA for a Surgical Ablation System, which is used by cardiac surgeons to ablate cardiac tissue during heart surgery using radio frequency (RF) energy. For more information please visit the Company's website at http://www.cardima.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 Cardima's amendment to its PMA for treating symptoms of atrial fibrillation including the expected time period for the FDA's review of that amendment and the possibility of receiving approval for the treatment, 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 Cardima's ability to obtain regulatory approval in the United States for its Ablation System for use in treating the symptoms of atrial fibrillation within its anticipated timeframes, if at all; risks associated with the Company's ability to successfully commercialize its Cardiac Ablation System in the United States and elsewhere if its Cardiac Ablation 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.
Source: Cardima
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