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Dr. Andrea Natale, Cleveland Clinic, Files Investigator IDE for use of the Cardima Linear Ablation Technology; First Use of the INTELLITEMP and the REVLEATION T-Flex in the Left Atrium of the Heart by an Electrophysiologist in the United States.


FREMONT, Calif. -- Cardima, Inc. (Other OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
: CRDM CRDM Control Rod Drive Mechanism
CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University)
CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) 
) announces that Dr. Andrea Natale, Medical Director for the Center for 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.
, Director of the Electrophysiology Laboratories, and Co-Section Head of Pacing and Electrophysiology in the Cleveland Clinic Department of Cardiovascular Medicine, has filed an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  (IDE) with 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.
 to use the Cardima, Inc.'s linear ablation technology to create continuous linear lesions in the left atrium of the heart Noun 1. left atrium of the heart - the left upper chamber of the heart that receives blood from the pulmonary veins
atrium sinistrum, left atrium

atrium cordis, atrium of the heart - the upper chamber of each half of the heart
 for the treatment of chronic atrial fibrillation (AF).

The IDE includes the use of REVELATION T-Flex microcatheter and the INTELLITEMP Energy Management System. The REVELATION T-Flex allows a doctor to make either straight or shaped lesions in a single placement of the catheter. The control of shape is governed by a mechanism within the handle of the device and is actuated and fully controlled by the doctor. The total length of any single lesion can range from 0.4 cm up to 8.0 cm and is also fully controlled by the doctor during the procedure. The INTELLITEMP Energy Management System allows the doctor to control all aspects of applying radio frequency (RF) energy through the REVELATON T-Flex to the target tissue. It controls and monitors multiple variables including temperature, power applied, individual electrode activation, and impedance. When combining both the INTELLITEMP and the REVELATON T-Flex, the doctor will have control of where placed, what shape, and how long any specific lesion they create within the heart, while saving valuable procedure time.

"Cardima's continuous linear ablation technology is very interesting and may help move us forward in the treatment of AF by allowing the medical practitioner the ability to create specific anatomically placed lesions in less time than is current state of practice. I look forward to the initiation of the trial," said Dr. Natale.

"Dr. Natale is both a pioneer and a leader in addressing the clinical challenge of treating AF within the specialty of electrophysiology. His development of a lesion specific technique for treating AF has gained worldwide recognition. His high effectiveness results make him a wonderful collaborator in investigating the Cardima linear ablation technology," said Gabe Vegh, President, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  and Acting CFO See Chief Financial Officer. . "We are pleased to be working with Dr. Natale and look forward to reviewing his study results, once completed."

About the REVELATION T-Flex

The REVELATION T-Flex has CE mark approval in Europe for the right atrium and incorporates eight coiled electrodes, eight tissue temperature-sensing elements and adds the ability to deflect (steer) the catheter to the desired location. The T-flex allows a high degree of flexibility to conform to the heart's wall to create a thin linear lesion, the temperature sensing elements are in direct contact with tissue to optimize accuracy of temperature monitoring; and the deflectability allows the physician to place the catheter precisely for effective treatment.

About the INTELLITEMP

The INTELLITEMP 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. The INTELLITEMP(R) was approved by the FDA in February 2003 and currently available for surgeons in the U.S.

About Cardima

Cardima, Inc. has developed the REVELATION Tx, REVELATION T-Flex and REVELATION Helix linear ablation microcatheters, the NAVIPORT deflectable guiding catheters, and the INTELLITEMP energy management system for the minimally invasive treatment of atrial fibrillation (AF. The REVELATION Tx, REVELATION T-Flex and REVELATION Helix systems and the INTELLITEMP have received CE Mark approval in Europe. The Company has also developed and obtained approval for in the USA a Surgical Ablation System, which targets market application by cardiac surgeons to ablate ab·late
v.
To remove or destroy the function of.



ablate

to remove, especially by cutting.

ablate verb To remove; excise
 cardiac tissue during heart surgery using radio frequency (RF) energy.

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 our 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.  application for the REVELATION Tx, including the ramifications ramifications nplAuswirkungen pl  of our recent meeting with the FDA, the prospect for any future clinical trials or regulatory activities, the Company's ability to obtain funding under the Agility loan facility, the risks associated with the Agility loan facility's restrictive covenants Restrictive covenants

Provisions that place constraints on the operations of borrowers, such as restrictions on working capital, fixed assets, future borrowing, and payment of dividends.
, security interest, fee provisions and other terms and conditions, the risk that the Company will not be able to raise additional capital in the immediate term as needed as needed prn. See prn order.  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-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, 2004, the Company's Quarterly Report on Form 10-Q Form 10-Q

See 10-Q.
 for the first quarter ended March 31, 2005, 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.
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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Geographic Code:1USA
Date:Jun 22, 2005
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