FREMONT, Calif.--(BW HealthWire)--Jan. 31, 1997--Cardima, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the Cardima PATHFINDER Series of microcatheters in the United States.
These novel microcatheters are designed to accurately
The Cardima PATHFINDER microcatheters are small and flexible, providing access to the regions of the beating heart that cause the arrhythmia. The catheters provide detailed information about the source of the arrhythmia so that the cardiologist can more effectively treat the patient.
"The Cardima PATHFINDER microcatheters along with Cardima's VENAPORT Coronary Sinus Guiding Catheters represent the first and only microcatheter system for intravascular electrophysiology mapping available in the United States.
"This innovative electrophysiology microcatheter mapping system provides access and enhances mapping to aid electrophysiologists to safely treat patients with potentially life-threatening tachycardias," stated Phil Radlick, Ph.D., President and Chief Executive Officer of Cardima.
"There are several hundred thousand people each year who are subject to an attack of potentially life threatening tachycardias. It is Cardima's mission to provide physicians with micro-catheter systems which can locate and eliminate the cause of these dangerous conditions.
"This clearance of our Cardima PATHFINDER Series is a significant event in our mission and a very important milestone for Cardima."
In addition to this FDA clearance, Cardima is ISO 9001 certified and has also received the CE mark for its diagnostic products in Europe and approval to market in Japan. As a result, Cardima PATHFINDER catheters have experienced clinical success in hospitals worldwide prior to receiving today's FDA clearance.
Cardima, Inc. designs, develops, manufactures and markets minimally invasive, microcatheter-based systems for the mapping and ablation of cardiac arrhythmias. Utilizing unique, proprietary microcatheter technology developed by Target Therapeutics, Inc., Cardima has established itself as the market leader in electrophysiology microcatheter systems.
CONTACT: Cardima, Inc.
Ron Bourquin, 510/354-0300, 888/354-0300