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Medical Device Daily Features Cardima's Technology to Treat Atrial Fibrillation.


Business Editors & Health/Medical Writers

FREMONT, Calif.--(BUSINESS WIRE)--Dec. 19, 2002

Cardima, Inc. (Nasdaq:CRDM CRDM Control Rod Drive Mechanism
CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University)
CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) 
) today announced that its REVELATION(R) microcatheter technology to treat atrial fibrillation atrial fibrillation

Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection.
 (AF) was featured as a lead article in the December 11, 2002 issue of Medical Device Daily (MDD MDD Major depressive disorder, see there ), written by Holland Johnson, MDD Senior Staff Writer. The full text of the article is available on the Company's Web site at www.cardima.com.

The article, entitled "Cardima is Finding its Niche with Atrial Fibrillation Devices," highlights the Company's technology, especially the REVELATION(R) family of microcatheters that are designed to treat AF in a minimally invasive procedure Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an . The technology is used to ablate ab·late
v.
To remove or destroy the function of.



ablate

to remove, especially by cutting.

ablate verb To remove; excise
 AF by creating long, thin, linear lesions in the atrium of the heart Noun 1. atrium of the heart - the upper chamber of each half of the heart
atrium cordis

atrial auricle, auricle, auricula atrii - a small conical pouch projecting from the upper anterior part of each atrium of the heart
, replicating the curative lines of scar created by the surgical maze procedure maze procedure Cox procedure Heart surgery A procedure used to manage A Fib. See Atrial fibrillation. Cf Corridor procedure. . The surgical maze is the only procedure to date known to provide a long-term cure; however, it is only done in conjunction with other open-heart surgical procedures. The article also discusses the FDA's acceptance of the Company's premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device.  (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
) application and grant of expedited review for the REVELATION Tx.

The article includes comments by Dr. Hugh Calkins, professor of medicine and Director of Electrophysiology Services at Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C.  in Baltimore, who participated in the right-sided linear ablation trial for the Revelation Tx. According to Dr. Calkins, "Three months after ablation 38% of patients had no AF and six months after ablation 47% had no AF."

Additionally, Dr. Calkins noted that the study group had significant episode reduction in symptomatic AF. The study group recorded an average of 10 AF episodes per month prior to ablation, an average of 3.7 AF episodes per month three months after ablation, and an average of 1.9 AF episodes per month six months after ablation.

Dr. Calkins commented, "This is the first prospective, multi-center clinical trial for catheter ablation of atrial fibrillation that has reached the finish line. I think that's the enormous hurdle that has been crossed. There were about 10 other companies that started the race, but all the rest packed it in. Cardima had the fortitude to stick with it and present us with results."

Dr. Calkins further noted that catheter ablation resulted in a significant improvement in quality of life. "I think catheter ablation will be routinely performed to cure afib -- that's clearly where we're moving," he commented.

Cardima, Inc. developed the REVELATION(R) Tx linear ablation microcatheter system as a minimally invasive, single-use product that may have the potential for curing AF. The REVELATION(R) Tx linear ablation microcatheter system is believed by the Company to be the first device to treat AF that has completed a multi-center clinical trial and has had a pre-market approval (PMA) application submitted to the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
. Cardima submitted the PMA on September 20, 2002 and was granted expedited review status by the FDA on November 5, 2002. Clinical trial data from the REVELATION(R) Tx microcatheter demonstrated safety and promising efficacy. Cardima's mission is to get better devices to treat AF in the hands of the medical community.

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 premarket approval application will be approved by the U.S. FDA, and whether the Company will be able to conduct successful clinical trials, obtain regulatory approvals and gain acceptance from the marketplace for its products. Additional risks are set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2001, filed with the Securities and Exchange Commission on April 1, 2002, and the Company's Quarterly Reports on Form 10-Q for the Quarters ended March 31, June 30, and September 30, 2002. 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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Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Dec 19, 2002
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