CRDM may be a play today as some minor news is out. Still like it long term, but will trade it in the meantime.
Tuesday March 16, 8:30 am ET
FREMONT, Calif.--(BUSINESS WIRE)--March 16, 2004--Cardima®, Inc. (NasdaqSC: CRDM) is reporting the first clinical use, in an electrophysiology (EP) application, of the company's INTELLITEMP® - Radio Frequency (RF) energy management device in conjunction with the REVELATION® series micro catheter to treat atrial fibrillation (AF).
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Dr. Jaswinder Gill, a consultant Cardiologist and Director of Electrophysiology at Guy's and St. Thomas Hospital in London performed the procedure on a patient suffering from paroxysmal AF using Cardima's REVELATION® Helix 2.5 STX microcatheter in conjunction with the INTELLITEMP®. The procedure took less than 30 minutes. This ablation process normally takes a minimum of 1.5 hours to 2 hours.
"We were greatly pleased to have the INTELLITEMP® added to our capabilities to treat AF. The issues of control, time savings, and safety are important considerations for us in treating AF," stated Dr. Gill after completion of the procedure.
"The first clinical case isolating the pulmonary veins using the Cardima Helix catheter with the Energy Management System in the electrophysiology setting is very encouraging," commented Gabriel Vegh, CEO of Cardima. "The INTELLITEMP® appears to have greatly reduced case procedure time, which is a very important step in the on-going development of viable treatment options for AF."
The CARDIMA INTELLITEMP®, which received in Europe the CE Mark clearance for EP applications on February 19, 2004, is a radiofrequency (RF) energy management device which is connected between a commercially available RF generator and the Cardima REVELATION series of linear ablation microcatheters. The function of the INTELLITEMP is to discretely channel RF energy to each individual electrode on the end of the microcatheter, thereby giving the medical practitioner the additional ability to control the length of each individual lesion through the selection of one or any combination of up to eight electrodes simultaneously.
About Cardima
Cardima, Inc. has developed the REVELATION® Tx, REVELATION T-Flex and REVELATION Helix linear ablation microcatheter systems for the minimally invasive treatment of atrial fibrillation (AF). The REVELATION Helix was developed for the treatment of AF originating in the pulmonary veins of the heart. The REVELATION Tx, REVELATION T-Flex and REVELATION Helix systems have received CE Mark approval in Europe. The Company has also developed a Surgical Ablation System, which is used by cardiac surgeons to treat AF by ablating cardiac tissue during heart surgery using radio frequency (RF) energy. In February 2003, the Company announced that it had received FDA 510(k) clearance to market the Surgical Ablation System in the U.S. To-date 18 patients have been treated successfully in the US with the system.
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 in such forward-looking statements. Potential risks and uncertainties include the Company's ability to raise additional capital, whether the Company's pre-market approval (PMA) application for the REVELATION® Tx or any other product will be approved by the FDA, the possibility of business disruption or unanticipated expenses due to the Company's recent staffing reduction and financing efforts, and whether the Company will be able to conduct successful clinical trials, obtain and maintain regulatory approvals, gain acceptance for its products from the marketplace, secure distribution partners or successfully market, sell and distribute its products to end users in the event FDA approval is obtained. Additional risks are set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2002, filed with the Securities and Exchange Commission on March 31, 2003, the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2003, the Company's Quarterly Report on Form 10-Q, as amended on Form 10-Q/A, for the quarter ended June 30, 2003, and the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2003. 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.
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Contact:
COMPANY CONTACT:
Cardima, Inc.
Barry D. Michaels, 510-354-0300
www.cardima.com
or
Investor Relations Group
INVESTOR CONTACTS:
Gino De Jesus, John Nesbett
Dian Griesel, Ph.D.
212-825-3210
MEDIA CONTACTS:
Janet Vasquez,
Dian Griesel, Ph.D.
212-825-3210
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Source: Cardima, Inc. |
