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Cardima Reports Continued Progress With Left-Sided Atrial Fibrillation Study.


Business Editors and Health/Medical Writers

FREMONT, Calif.--(BW HealthWire)--Oct. 12, 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) 
):
-- Four Patients Successfully Treated at the University of Hamburg

-- University of Munich Prepares for Patient Enrollment

-- Dresden Heart and Cardiovascular Institute Added to the Study


Cardima(R), Inc. (Nasdaq:CRDM) 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 of the heart.

The University of Hamburg As of 2006, the University of Hamburg supports 6 Collaborative Research Centres (Sonderforschungsbereiche, SFB), 6 Research Groups, 7 Research Training Groups (all funded by the DFG), 2 Max Planck Inter-national Research Schools, 13 Young Scientist Groups (Emmy-Noether-Programme, BMBF,  in Germany, the second center in Germany, has treated its first four patients 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.

Under the auspices of Professor Dr. T. Meinertz, Head of the Department of Electrophysiology at the University of Hamburg, Dr. Stephan Willems, Dr. Christian Weiss and their team successfully treated these four patients with the REVELATION Helix microcatheter, targeting arrhythmias originating in the pulmonary veins of the left side of the heart.

Willems stated, "The REVELATION Helix remained in a stable position allowing continuous electrogram recording during the procedures and appropriate circumferential ablation. Conduction capabilities of two to three pulmonary veins of each patient were either completely abolished or markedly attenuated Attenuated
Alive but weakened; an attenuated microorganism can no longer produce disease.

Mentioned in: Tuberculin Skin Test


attenuated

having undergone a process of attenuation.
 after completion of the procedure without any complications. To date, no sustained episodes of AF have recurred in any of the treated patients."

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
 using a single microcatheter with a unique helical-shaped tip. This unique 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 required amount of energy delivered through the flexible, miniature electrodes for successful treatment is only a small fraction of what is normally delivered by the conventional large tip electrodes. The Company believes that no other device to date offers these capabilities in a single catheter and that the potential advantages of the REVELATION Helix include ease of use, faster procedure times and more effective and safer treatments at lower energy levels.

Cardima plans to continue to expand its European study of the REVELATION Helix to include the University of Munich, under the auspices of Professor Dr. C was a fictional scientist from the TV series Cro. She and her companion, Mike, went to the Arctic and thawed out a mammoth, who could talk. That mammoth now tells stories of life in the stone age with his friend, Cro, and his fellow mammoths. . Schmitt, who is expected to begin patient treatment beginning the week of Oct. 22. Additionally, the Dresden Heart and Cardiovascular Institute, Dresden, Germany, under the auspices of Dr. S Dr.

Doctor.


dr.

dram.
. G. Spitzer, has received approval to begin patient treatment, which is expected to begin in early November.

"We are encouraged by the continued initial successes using the REVELATION Helix," said 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. Our investigators continue to monitor patients and all remain in normal sinus rhythm sinus rhythm
n.
A normal cardiac rhythm proceeding from the sinoatrial node.
 with no procedure-related complications. We are planning to seek regulatory approvals in Europe for the treatment of AF originating in the pulmonary veins before the end of 2001."

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. Cardima has 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 underway in the U.S. for its Revelation Tx linear ablation microcatheter system. The Company believes enrollment in the Phase III trial will be completed at the end of calendar year 2001.

Except for the historical information contained herein, the matters discussed in this news 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, 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 Dec. 31, 2000 and Quarterly Reports on Form 10-Q Form 10-Q

See 10-Q.
 for the quarters ended March 31 and June 30, 2001, filed with the Securities and Exchange Commission on March 22, May 14 and Aug. 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.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 12, 2001
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