Cardiac Pathways Receives FDA Clearance For its Radii Diagnostic Catheter.SUNNYVALE, Calif.--(BW HealthWire)--Jan. 6, 1999--Cardiac Pathways Corp. (Nasdaq: CPWY) today announced that it has received clearance from the U.S. Food and Drug Administration (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. ) of its 510(k) application to commercially release its Radii ra·di·i n. A plural of radius. radii Noun a plural of radius (R) steerable, diagnostic catheter for use in performing single-point mapping procedures in patients with certain types of abnormally rapid heart rhythms, predominantly supraventricular tachycardia supraventricular tachycardia n. Abbr. SVT A tachycardia that originates above the ventricles of the heart, as in the atria or the atrioventricular node. (SVT SVT supraventricular tachycardia. SVT abbr. supraventricular tachycardia SVT Supraventricular tachycardia, see there ). Single-point mapping techniques are widely used for diagnosing SVT because 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 can be induced and maintained in the patient for a sufficient length of time necessary to identify the origins of the SVT without posing substantial risks to the patient. The Radii catheter has a deflectable, steerable shaft that can be used with single-point mapping techniques to locate potential arrhythmia sites prior to therapeutic treatment. Steerability of the catheter is an important feature that allows small catheter tip movements that are necessary to effectively reach different anatomical locations within the heart chamber. "Receiving FDA marketing clearance for the Radii catheter is a complementary step in our strategic development of a broad product portfolio for the diagnosis and treatment of cardiac arrhythmias. We believe the Radii catheter approval represents the first of several important regulatory events for the company in 1999," said William N. Starling starling, any of a group of originally Old World birds that have become distributed worldwide. Starlings were brought to New York in 1890; since then the common starling (Sturnus vulgaris) has spread throughout North America. , president and chief executive officer of Cardiac Pathways. The company will market the Radii product line through its direct sales force in the U.S. and plans to begin shipping the Radii catheter in the U.S. market within the current calendar quarter. Cardiac Pathways designs, develops and manufactures 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 ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. systems for the diagnosis and treatment of heart rhythm disturbances. 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 completing any remaining development of its products, the efficacy and safety of the products in the laboratory, clinical and other testing, the uncertainties relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc FDA and other regulatory approvals, and additional factors. |
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