Cardiac Pathways Receives HCFA Pass-through Approval for Its Innovative Chilli and Chilli RPM Catheter Product Lines.Business Editors and Health/Medical Writers SUNNYVALE, Calif.--(BW HealthWire)--October 9, 2000 Approval aids hospitals in maintaining their bottom lines while adopting the latest in catheter ablation Catheter Ablation Definition Catheter ablation of an irregular heartbeat involves having a tube (a catheter) inserted into the heart through which electrical energy is sent to either reset the heartbeat or stop the heart from beating so a mechanical technologies Cardiac Pathways Corporation, a leader in state-of- the-art 3D cardiac mapping and ablation technology (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CPWY), today announced it has received Health Care Financing Administration Health Care Financing Administration, n.pr department in the U.S. agency of Health and Human Services responsible for the oversight of the Medicaid and Medicare benefit programs, including guidelines, payment, and coverage policies. (HCFA HCFA abbr. Health Care Financing Administration HCFA, n.pr See Health Care Financing Administration. ) pass-through Medicare reimbursement for its innovative Chilli(R) and Chilli(R) Realtime Position Management(R) catheter product lines. The use of the HCFA pass-through reimbursement codes can enable hospitals to potentially recoup the additional costs associated with utilizing these new technologies. "The HCFA approval represents a major milestone for our customers," said Thomas M. Prescott, President and Chief Executive Officer of Cardiac Pathways. "The Chilli and Chilli RPM products have demonstrated to physicians that they are important tools in the diagnosis and treatment of cardiac arrhythmias. Our clinicians tell us these tools can significantly reduce procedure times and improve the effectiveness of the procedures. Now their hospitals can potentially offset any incremental costs associated with using these new tools." Last July, HCFA modified its reimbursement levels to conform to Medicare's new Ambulatory Payment Classification (APC (1) (American Power Conversion Corporation, West Kingston, RI, www.apcc.com) The leading manufacturer of UPS systems and surge suppressors, founded in 1981 by Rodger Dowdell, Neil Rasmussen and Emanual Landsman, three electronic power engineers who had worked at MIT. ) codes. These codes did not include new technologies such as the Chilli Cooled Ablation Catheter. Subsequently, HCFA established new criteria allowing for separate reimbursement for certain medical technologies that qualify as pass-through medical devices, helping ensure adequate reimbursement is provided. The United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. approved the sale and marketing of the Chilli rpm(R) Cooled Ablation Catheter last March. It is the only such catheter approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for ablation of non-idiopathic ventricular tachycardia. Its closed-path fluid circulation controls the catheter tip temperature during ablation. Studies have shown that by controlling the temperature electrophysiologists have been better able to deliver energy and larger lesions to ablate ab·late v. To remove or destroy the function of. ablate to remove, especially by cutting. ablate verb To remove; excise cardiac tissue responsible for the arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of . Used in combination with the company's RPM(TM) Tracking System, physicians have been able to accurately manipulate the Chilli catheters within the heart during ablation procedures without the aid of fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope. fluo·ros·co·py n. Examination by means of a fluoroscope. Also called radioscopy. . The RPM system allows for realtime visualization of the catheters and offers the potential for reduction in procedure times. About Cardiac Pathways Cardiac Pathways (www.cardiac.com) 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. 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 gain 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 Chilli RPM 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 |
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