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Cardima Reports Continued Progress With The REVELATION Helix Pulmonary Vein Atrial Fibrillation Study; Six Patients Treated at the University of Munich.


Business Editors & Health/Medical Writers

FREMONT, Calif.--(BW HealthWire)--Dec. 4, 2001

Cardima(R), 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 continued progress of its multi-center study for treating 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) originating in the pulmonary veins pulmonary vein
n.
A vein that carries oxygenated blood from the lungs to the left atrium of the heart.
 of the heart.

The first six patients have been successfully treated with the Company's REVELATION(TM) Helix(TM) radiofrequency (RF) ablation ablation /ab·la·tion/ (-shun)
1. separation or detachment; extirpation; eradication.

2. removal or destruction, especially by cutting.


ab·la·tion
n.
 microcatheter at the University of Munich, the third active center in Germany in this study.

The study is being conducted under the auspices of Professor Dr. med. Claus Schmitt, Chairman of the Department of Electrophysiology electrophysiology /elec·tro·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je)
1. the study of the mechanisms of production of electrical phenomena, particularly in the nervous system, and their consequences in the living organism.

2.
, at the University of Munich, and Dr. Isabel Diesenhofer and her team.

Dr. Diesenhofer stated, "The REVELATION Helix is an exciting new catheter, which can be introduced quickly, easily and without complications into the pulmonary veins using the steerable Naviport long sheath sheath (sheth) a tubular case or envelope.

arachnoid sheath  the continuation of the arachnoidea mater around the optic nerve, forming part of its internal sheath.
. The REVELATON Helix is both easy to handle and placement into an optimal position is easy to perform. In fact, we found that the REVELATION Helix, when used in conjunction with the Naviport guide, provides unique handling and allows for angiographic dye injection, giving the physician the ability to view the actual position of the Helix catheter with respect to the vein's anatomy. The signal quality of the pulmonary vein potentials is excellent, probably due to the small inter-electrode spacing, so that vein potentials can be detected accurately and energy can be delivered to the site quickly."

The REVELATION Helix combines the ability to both map and ablate ab·late
v.
To remove or destroy the function of.



ablate

to remove, especially by cutting.

ablate verb To remove; excise
 arrhythmia-causing tissue using a single microcatheter. This capability to both diagnose and treat a patient using a single catheter allows the physician to place the microcatheter in the appropriate position in the pulmonary veins in a single step procedure. The Company believes that no other device to date offers these capabilities in a single catheter. The potential advantages of the REVELATION Helix and the Naviport steerable guide include ease of use, faster procedure times and more effective and safer treatments.

"We continue to be encouraged by the initial successes using the REVELATION Helix, and the investigators continue to be excited by the potential for the REVELATION Helix in addressing atrial fibrillation originating in the pulmonary veins," said Mr. Gabriel Vegh, chief executive officer of Cardima. "Investigators report that the REVELATION Helix is relatively easy to place in the ostium ostium /os·ti·um/ (os´te-um) pl. os´tia   [L.] an opening or orifice.os´tial

ostium abdomina´le tu´bae uteri´nae
 of the pulmonary veins and remains stable throughout the procedure. We anticipate CE mark approval for the REVELATION Helix before the end of 2001."

Cardima plans to expand its European study of the REVELATION Helix to include the Dresden Heart and Cardiovascular Institute, Dresden, Germany, under the auspices of Dr. med. Stefan G. Spitzer.

The REVELATION Helix is currently only available for this European study and is not commercially available in the U.S.

Cardima, Inc. developed its patented, unique series of REVELATION microcatheter systems for the mapping and treatment of AF, which the Company believes is a potential $6 billion market that is poorly served by current treatment alternatives. AF afflicts an estimated 4.5 million people worldwide. The REVELATION series of microcatheters is a minimally invasive, single-use microcatheter for potentially curing AF. Enrollment in a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  study for the Company's Revelation Tx linear ablation microcatheter system is underway in the U.S. The Company is targeting U.S. approval for this device before the end of 2002.

Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 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, 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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2000 and Quarterly Reports on Form 10-Q Form 10-Q

See 10-Q.
 for the quarters ended March 31, June 30, and September 30, 2001 filed with the Securities and Exchange Commission on March 22, May 14, August 14, 2001 and November 14, 2001, respectively. 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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Publication:Business Wire
Geographic Code:1USA
Date:Dec 4, 2001
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