To: Michael $ who wrote (87954 ) 8/5/1999 10:13:00 AM From: flyboy Read Replies (1) | Respond to of 119973
CRDM...Thursday August 5, 6:08 am Eastern Time Company Press Release Cardima, Inc. Announces FDA Clearance of Naviport Deflectable Tip, Hollow Lumen Guiding Catheter A New Generation of Guiding Catheters FREMONT, Calif.--(BW HealthWire)--Aug. 5, 1999--Cardima, Inc. (Nasdaq:CRDM - news) today announced that it has received United States Food and Drug Administration (FDA) 510(k) clearance to begin marketing its proprietary Naviport(tm) deflectable tip guiding catheter. The patented Naviport is the only deflectable tip guiding catheter with an open lumen or tube, designed to access the chambers and/or the coronary vasculature of the heart. Guiding catheters are used as conduits by physicians to direct catheters to specific sites in the body. The Naviport shortens electrophysiology procedure times through faster catheter placement by its unique ability to steer to a particular location. The Naviport also received European Union CE mark approval in March of 1999. ''The Naviport is the latest addition to Cardima's family of guiding catheters that include the Venaport® line of guiding catheters and Vueport(tm) line of balloon occlusion guiding catheters,'' said Phillip Radlick, Ph.D., President and Chief Executive Officer of Cardima. ''The Naviport is a key component of Cardima's therapeutic ablation system currently in clinical trials in the United States for treatment of atrial fibrillation (AF). It has the potential for broad applications to deliver a wide range of small, high technology, non-steerable catheters to the body.'' Features of the Naviport include an ergonomic control knob offering physicians precise, controlled steering with appropriate curvature while maintaining the selected curve shape, and an open lumen or tube with a deflectable tip that provides easy delivery, placement and support of catheters in the desired location. The Naviport will be marketed in various diameters and curve sizes and is available through Cardima's direct salesforce in the United States and web site at www.cardima.com. 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. For further information about atrial fibrillation and ventricular tachycardia, visit Cardima's website at www.cardima.com. 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 limitation, those set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 1998 as amended March 23, 1999 and subsequent periodic reports filed with the Securities and Exchange Commission, and the Company's ability to complete successful clinical trials, obtain timely regulatory approvals and gain acceptance from the marketplace for its products.