Cardima PMA for Treatment of Atrial Fibrillation Symptoms to Be Reviewed by FDA Dispute Resolution Panel
FREMONT, CA--(MARKET WIRE)--Mar 22, 2007 -- Cardima, Inc. (OTC BB:CADM.OB - News), 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 PATHFINDER® and REVELATION® Series of diagnostic catheters, the INTELLITEMP® Energy Management Device, and the Surgical Ablation System (SAS). All of these devices are CE marked and received U.S. FDA 510(k) clearance. The REVELATION® Series of ablation catheters with the INTELLITEMP® EP Energy Management Device was developed and marketed for the treatment of atrial fibrillation (AF) after receiving CE mark approval in Europe; it is not currently available in the U.S.
Forward-Looking Statements
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by such forward-looking statements. Potential risks and uncertainties include: the uncertainties associated with the prospects for FDA approval of any new devices; the prospect for any future clinical trials or regulatory activities; the risk that the Company will not be able to raise additional capital in the immediate term as needed to continue operations and the risk that we will be unable to secure a strategic transaction involving the Surgical Ablation System. Additional risks and uncertainties are set forth in the Company's Annual Report on Form 10-KSB for the year ended December 31, 2006, the Company's Quarterly Report on Form 10-QSB for the third quarter ended September 30, 2007, and in the Company's subsequent SEC filings. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events or changes in the Company's plans or expectations.