Cardiac Pathways Announces 510k Clearance OnRevolutionary New RPM Tracking System.

Business Editor/Health & Medical Writers

SUNNYVALE, Calif.--(BW HealthWire)--March 13, 2000

Cardiac Pathways Corporation (Nasdaq:CPWY) announced today that it has received clearance from the FDA to begin marketing the revolutionary new RPM(TM) (Real-time Position Management)

This proprietary technology, developed by the Company, can be used in most diagnostic electrophysiology procedures for real-time visualization of catheters and is expected to assist physicians in precisely manipulating catheters within the heart during procedures, offering the potential for reductions in procedure times.

The RPM(TM) catheters contain ultrasound transducers that are used to precisely triangulate, in real-time, the position of the catheters during a diagnostic procedure. The supporting RPM(TM) Tracking System computer combines the ultrasonic signals with 3D graphics to display real-time catheter positions and track catheter movement, while recording the associated intercardiac electrical signals.

"We are extremely pleased by the timely FDA action in granting this 510(k) clearance," stated Thomas M. Prescott, President and CEO of Cardiac Pathways. "The clearance paves the way for our planned introduction of this revolutionary technology at the NASPE conference in May. Rollout of initial systems to early users can now begin within the next 60 days. We look forward to providing clinicians with advanced tools that are intuitive to use and easy to learn and believe they will quickly see the value of using the RPM(TM) Tracking System for a majority of procedures -- not just for the toughest cases."

"The current worldwide conventional EP diagnostic mapping and ablation market is approximately $300 million. We believe the RPM(TM) Tracking System has the potential to help revolutionize this market and participate in the expected growth towards $1 billion by 2005. Additionally, we believe the RPM(TM) technology and its capability for precise localization and return-to-site accuracy, complements existing treatment modalities and emerging technologies in the broader space of Cardiac Rhythm Management and Interventional Cardiology," Prescott continued.

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 RPM(TM) Tracking System, (ii) the potential reduction in procedure times, (iii) the planned introduction of the RPM(TM) Tracking System within 60 days, (iv) the ease of use and acceptance by clinicians of advanced tools which incorporate the RPM(TM) Tracking System and (v) the expected growth of the conventional EP diagnostic mapping and ablation market to $1 billion by 2005. 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 RPM(TM) 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 RPM(TM) Tracking System will be commercially adopted by physicians, whether RPM(TM) technology complements existing and emerging treatment modalities 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.