Cardiac Pathways Announces Key 510k FDA Filing.

SUNNYVALE, Calif.--(BW HealthWire)--Sept. 10, 1999--

Cardiac Pathways Corporation (Nasdaq:CPWY) announced today that it has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for marketing clearance of a suite of products based on its Tracking System technology.

"This news is very significant to our stockholders for two reasons," said Thomas M. Prescott, President and CEO. "First is the fact that this application was originally expected to be submitted later this fall. Recognizing the importance of the Tracking technology and our need to deliver on this key milestone, our employees remained focused to make this happen ahead of schedule. That focus and successful execution shows real commitment by the Cardiac Pathways team.

"And second, we believe that the filing is a significant step toward commercializing this technology which will offer clinicians rapid assessment, mapping, and ablation of complex arrhythmias -- with the opportunity to visualize the position of multiple electrophysiology (EP) catheters in the heart simultaneously, in three dimensions, and in real-time. We do not believe this capability is available with any competitive product. It provides the potential for decreasing EP procedure times and reducing the dependence on fluoroscopy to benefit patients, physicians, hospitals, and payors."

The Cardiac Pathways Tracking System consists of a line of diagnostic catheter products and a computer-based system for recording cardiac electrograms. The catheters contain ultrasound transducers that are used to precisely triangulate, in real-time, the position of catheter electrodes within the heart during the diagnostic procedure.

The supporting computer system combines real-time 3D graphics, displaying catheter images while recording the associated intracardiac electrical signals. The system is expected to assist physicians to precisely manipulate catheters within the heart during a diagnostic procedure without the aid of fluoroscopy and to carefully document intracardiac sites involved in the arrhythmia.

The Tracking System technology is also currently being integrated with Cardiac Pathways' therapeutic catheter for ablative treatment of arrhythmias using radiofrequency (RF) energy. We expect to submit an application for market approval of the Chilli Ablation Catheter with integrated Tracking technology to the FDA later this fall. In February 1999, Cardiac Pathways received market approval from the FDA for its Chilli(R) Cooled Ablation System for the treatment of patients with ventricular tachycardia (VT), a life threatening, rapid heart rhythm.

Cardiac Pathways develops, manufactures and markets minimally invasive systems to diagnose and treat cardiac tachyarrhythmias (abnormally rapid heart rhythms). The company is a pioneer and leader in the development of complete integrated mapping and ablation systems for the diagnosis and treatment of heart rhythm disturbances.

Statements included in this release that are not historical or current are "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements and uncertainties include (i) the range of clinical utility for the Tracking System, (ii) the potential reduction in procedure times and, (iii) the potential for reduced x-ray exposure from fluoroscopy. The risks and uncertainties which could cause actual results to differ materially from those anticipated in these forward-looking statements include, but are not limited to the Company's ability to complete the development of the Tracking System, market acceptance of the Company's products, the Company's ability to successfully obtain regulatory clearance or approvals to market its products, the ability of the Company to cost effectively manufacture and distribute products in commercial quantities, whether the Tracking System will be approved by the FDA or commercially adopted by physicians, the timing of the submission of our application to integrate the Tracking System with our Chilli Ablation Catheter and whether and when such application, if submitted, will be approved, and the Company's ability to effectively compete in the field of electrophysiology against its competitors, many of which have substantially greater financial and other resources.