Cardiac Pathways Receives FDA Approval for Its Chilli Cooled Ablation System for Treating Irregular Heart Rhythms.

SUNNYVALE, Calif.--(BW HealthWire)--Feb. 3, 1999--Cardiac Pathways Corp. (Nasdaq:CPWY) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its premarket approval (PMA) application to commercially release its Chilli(R) Cooled Ablation System.

The Chilli Cooled Ablation System is designed to treat patients with ventricular tachycardia (VT), a life threatening, rapid heart rhythm that usually originates in the left ventricle -- the main, lower pumping chamber of the heart. Most VT results from coronary artery disease and the scarring that follows a heart attack. The majority of VT patients are currently treated with drug therapy and/or implantable defibrillators.

Catheter ablation is a less invasive technique, which attempts to eliminate the rhythm disturbance at its source. The catheter ablation procedure uses radiofrequency (RF) energy delivered through a catheter to neutralize the heart tissue responsible for the abnormal heart rhythm.

Designed for VT ablation, the Chilli Cooled Ablation System addresses the need to make lesions that can penetrate thick ventricular scar tissue and target ablation sites deep within the heart's wall. The Chilli catheter contains small lumens, or tubes, that circulate saline through the tip of the catheter during RF energy delivery.

This fluid circulation removes heat that can build up during ablation and that limits the effectiveness of the procedure. The system includes a radiofrequency generator that contains an integrated fluid pump to move the saline liquid through the catheter while delivering RF ablative energy.

The Cardiac Pathways Chilli Cooled Ablation System provides a new treatment option for approximately 160,000 of the 400,000 people per year in the U.S. who suffer from or are at high risk for VT.

The company will market the Chilli product line through it direct sales force in the U.S. and plans to begin shipping in the U.S. market within the current calendar quarter.

"Receiving FDA marketing approval for the Chilli Cooled Ablation System is a major accomplishment for Cardiac Pathways. We believe that the system represents a significant treatment advance for patients with dangerous arrhythmias like VT," stated William N. Starling, president and chief executive officer of Cardiac Pathways. "We are very pleased with the Chilli approval and look forward to launching the first product indicated for this use in the U.S. market."

The Chilli Cooled Ablation System was evaluated in clinical trials conducted at 15 sites in the U.S. and involved 188 patients, most of whom had severe cardiac disease. In these trials, 75 percent of patients treated with the cooled ablation system experienced acute success, where acute success is defined as eradication of all mappable VT at the end of the ablation procedure.

This release contains certain forward-looking statements that involve risks

and uncertainties. Actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the company's success in manufacturing the product in commercial quantities, developing an effective marketing and distribution channel for the product and creating market acceptance of the product versus alternative therapies or products, as well as completing any remaining development of its other products, the efficacy and safety of the products in the laboratory, clinical and other testing, the uncertainties relating to FDA and other regulatory approvals, and additional factors.