Cardima, Inc. Receives FDA Approval of IDE for Initial Phase of Atrial Fibrillation Study

Business Wire, July 9, 1997

FREMONT, Calif.--(BW HealthWire)--July 9, 1997--Cardima, Inc., (NASDAQ:CRDM) announced today that the FDA had approved the Company's investigational device exemption (IDE) submission to begin its initial atrial fibrillation (AF) study in the United States for the Cardima Pathfinder microcatheter system.

The study will be conducted at Stanford University Hospital and Massachusetts General Hospital. This initial study in six patients will attempt to demonstrate the effective placement of catheters in the atria, or upper chambers of the heart, which is necessary for catheter-based treatment of the disease.

AF is characterized by the irregular and very rapid beating of the heart's atrial chambers and results when the normal electrical conduction malfunctions, leading to irregular, disorganized and quivering spasms of atrial tissue. These spasms may lead to reduced blood flow, blood clots, stroke and even death.

It is estimated that AF is responsible for more than 200,000 hospital admissions and 1,500,000 outpatient visits each year. AF is responsible for over 70,000 strokes in the United States and the cost of treating these patients is more than $3.6 billion annually.

Phillip C. Radlick, Ph.D., president and chief executive officer of Cardima stated, "We are extremely pleased the FDA has approved this first step in Cardima's AF program. Our unique catheter systems are designed to rapidly find the location of the arrhythmia-causing tissue so that the physician can determine the severity of the disease and course of treatment for the patient. Our goal is to provide a catheter that can both find and treat this condition in a minimally invasive, cost-effective procedure."

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. -0-

Note: Except for the historical information contained herein, this press release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties. Actual events or results may differ materially due to factors set forth from time to time in Cardima's filings with the Securities and Exchange Commission.

CONTACT: Cardima, Inc.

Phillip C. Radlick, 510/354-0300