Cardima Receives FDA Clearance to Market the Cardima Pathfinder Series of Mapping Catheters in the United States.FREMONT, Calif.--(BW HealthWire)--Jan. 31, 1997--Cardima, Inc. announced today that it has received U.S. Food and Drug Administration (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. ) clearance to market the Cardima PATHFINDER Series of microcatheters in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . These novel microcatheters are designed to accurately locate the source of cardiac arrhythmias known as tachycardias (abnormally fast heartbeats). The Cardima PATHFINDER microcatheters are small and flexible, providing access to the regions of the beating heart that cause the arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of . 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 coronary sinus n. A short trunk receiving most of the veins of the heart, running in the posterior part of the coronary sulcus and emptying into the right atrium between the inferior vena cava and the atrioventricular orifice. Guiding Catheters represent the first and only microcatheter system for intravascular intravascular /in·tra·vas·cu·lar/ (in?trah-vas´ku-lar) within a vessel. in·tra·vas·cu·lar adj. Within one or more blood vessels. 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 (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 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 ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. 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 |
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