Cardima Announces FDA Clearance of the Revelation Microcatheter for Diagnosis of Atrial Cardiac Arrhythmias.

FREMONT, Calif.--(BW HealthWire)--Nov. 11, 1997--Cardima Inc. (NASDAQ:CRDM) today announced that the U.S. Food and Drug Administration (FDA) has granted 510K clearance to market its Revelation(TM) endocardial microcatheter for the diagnosis of atrial cardiac arrhythmias such as atrial fibrillation (AF), a heart rhythm abnormality that threatens the lives of two million Americans and causes over 70,000 strokes per year.

The Revelation microcatheter, which represents the company's first product for diagnosis of atrial fibrillation to reach the market in the United States, is available immediately.

The Revelation is specially designed to conform to the endocardial surface and to record electrical signals and pace during diagnostic electrophysiology studies. Its thin, flexible, multi-electrode design permits access to any area of the atria. Furthermore, it allows electrophysiologists to rapidly collect and evaluate more information than conventional mapping catheters.

This reduces patient exposure to fluoroscopy (x-ray) and can reduce both procedure time and potentially costs. In addition, Revelation is compatible with existing signal display systems, eliminating the need for investment in new capital equipment.

"The introduction of the Revelation endocardial microcatheter for AF, coupled with our Pathfinder microcatheter series for mapping ventricular tachycardia (VT), significantly strengthens Cardima's position in the electrophysiology market," said Phillip Radlick, Ph.D., president and chief executive officer of Cardima.

"The Revelation paves the way for the introduction of our other advanced and innovative systems for the diagnosis and eventual treatment of AF and VT, the two largest unmet clinical needs in cardiovascular medicine."

Revelation, currently marketed in Europe under the brand name Pathfinder 3mm Mapping Microcatheter(TM), is part of Cardima's Pathfinder series of products specifically designed for the diagnosis of AF and VT. The company has initiated clinical trials of its microcatheter systems for AF ablation in Europe and expects to file Investigational Device Exemptions (IDE's) in the U.S. for treatment of atrial fibrillation and ventricular tachycardia before the end of this year.

Cardima Inc. designs, develops, manufactures and markets minimally invasive, single-use microcatheter-based systems for the dual purpose of finding and treating the two most common forms of cardiac arrhythmias: atrial fibrillation, a condition of the heart characterized by the irregular and very rapid beating of the heart's atrial chambers, and ventricular tachycardia, a life-threatening condition in which heartbeats are improperly initiated from within the ventricular walls, bypassing the heart's normal conduction system.

Cardima is the only company developing unique microcatheter systems to be used in both diagnosing and treating AF and VT.

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, without limitations, those set forth in the company's Registration Statement on Form S-1 and periodic reports filed with the Securities and Exchange Commission, and the company's ability to conduct successful clinical trials, obtain timely regulatory approvals and gain acceptance from the marketplace for its products.

CONTACT: Cardima Inc.

Ron Bourquin, 510/354-0162

or

Burns McClellan Inc.

Audra Nass or Leah Fine, 415/352-6262