ATRIAL FIBRILLATION DATA FROM UK STUDY EVALUATING THE CARDIMA EP ABLATION SYSTEM
FREMONT, CA--(MARKET WIRE)--June 12, 2008, Cardima, Inc. (OTC BB:CADM.OB - News) Leading Electrophysiology Physicians at Guy’s and St. Thomas Hospital, London, UK, have concluded a portion of a study for the treatment of Atrial Fibrillation (“AF”). Guy’s and St. Thomas Hospital is a leading cardiac center located in the center of London, England. Patients with both paroxysmal and persistent AF were included in this trial. Cardima’s EP Ablation System is being used to treat the patients. To date, Guy’s and St. Thomas Hospital has treated over 110 AF patients using the Cardima System.
This UK single center study is on-going, and to date, 30 patients have completed the follow-up monitoring necessary to define success. The principal investigator of the study, Jaswinder Gill MD, FRCP, recently compiled this data on the first 30 patients and presented it at the Fourth Annual Congress of the European Cardiac Arrhythmia Society (ECAS) in Marseille, France on April 13-15th, 2008. His abstract, titled: “Performance of a Novel Linear Catheter Ablating System for Left and Right Atrial Compartmentalization to Reproduce MAZE Operation” has also been accepted for publication by the Journal of Interventional Cardiology and Electrophysiology (“JICE”) and is included in Volume 22:1, 2008.
In commenting on his study, Dr. Gill stated: “This early patient data demonstrates that the Cardima EP Ablation System is safe for use in the left atrium. It also illustrates how the Cardima catheter, the REVELATION® T-Flex, can be used to create lesions in the left and right atrium that mimic the Cox Maze for the treatment of AF in a safe and effective manner. Our team looks forward to working with Cardima to expand our study and build a robust body of data that will assist in establishing this linear ablation system as a safe and effective tool for the treatment of AF. Identifying new patient treatment options for AF that are safe and effective is an important public health issue for the UK and many countries around the world.”
Cardima’s CEO, Robert Cheney, acknowledged the important contribution by Dr. Gill and the team at Guy’s and St. Thomas Hospital, "Cardima is very proud to be associated with Guy’s and St. Thomas’s Hospital, a leader in cardiac care, and the highly professional team led by Dr. Gill. The data presented will benefit patients across the UK and the European Union who are in need of AF treatment. We look forward to working with Dr. Gill and his team to expand this study to more centers in the UK over the coming months.”
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.