Cardiac Pathways Announces Pre-Market Approval for New Chilli Cooled Ablation Catheter With RPM Tracking.

Business Editors, Health/Medical Writers

SUNNYVALE, Calif.--(BW HealthWire)--March 21, 2000

Cardiac Pathways Corporation (NASDAQ: CPWY) announced today that it has received Pre-Market Approval (PMA) for its new Chilli(R)rpm cooled ablation catheters incorporating the company's unique Real-time Position Management(TM) (RPM) navigation technology.

Implementing a number of significant design improvements to Cardiac Pathways' popular Chilli(R) cooled ablation catheters, the new 7 French platform includes a bi-directional steering capability and integrates the Company's ultrasound transducer technology for dynamic real-time catheter navigation and visualization. New models for the Chilli with and without the navigation and catheter visualization technology were approved with this PMA.

The recent FDA 510(k) clearance of Cardiac Pathways' RPM Tracking System establishes a new standard for diagnostic mapping, 3D navigation and visualization of catheters. The PMA approval of Chillirpm provides the additional ingredient necessary to efficiently utilize the technology in a therapeutic capacity. By adding an approved, temperature-sensing, closed-system cooled ablation catheter to the line of RPM diagnostic catheters, RPM is now the only commercially available system to integrate real-time, 3D catheter navigation with state-of-the-art ablation technology. Moreover, the intuitive nature of the product makes it appropriate for most procedures performed in the Electrophysiology Laboratory. The addition of Chillirpm to its already-impressive tool set reinforces Cardiac Pathways' position as the technology leader in 3D catheter visualization, navigation and advanced ablation.

"This timely approval means two significant things for Cardiac Pathways' customers," stated Thomas M. Prescott, President and CEO. "First, we will now be able to offer the only approved real-time 3D catheter visualization system integrated for mapping and ablation. Feedback from key clinicians indicates this integrated system can deliver substantial clinical and economic value through improved catheter navigation and reduction of procedure times. We believe the potential served market that results from this compelling new technology will exceed 400,000 EP procedures performed annually."

Prescott continued, "Secondly, this approval allows us to add key new features customers consider essential for our Chilli and Radii(R) products - including a bi-directional steering capability - all on a common 7 French platform."

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 in the electrophysiology lab, (ii) the additional ingredient necessary to efficiently utilize the technology in a therapeutic capacity, (iii) deliver substantial clinical and economic value through improved catheter navigation and reduction of procedure times, (iv) the potential served market that results from this compelling new technology will exceed 400,000 EP procedures performed annually. 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 Tracking System and Chillirpm cooled ablation catheter, 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 Tracking System and Chillirpm cooled ablation catheter will be commercially adopted by physicians, whether RPM 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.