Biosense Webster Receives FDA Market Clearance for Pediatric Use of its Diagnostic Catheters.Business Editors and Health/Medical Writers DIAMOND BAR, Calif.--(BW HealthWire)--Jan. 10, 2000 First to Receive Pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. Clearance for Both Therapeutic and Diagnostic Electrophysiology electrophysiology /elec·tro·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je) 1. the study of the mechanisms of production of electrical phenomena, particularly in the nervous system, and their consequences in the living organism. 2. Catheters Biosense Webster, a leading innovator of endocardial endocardial /en·do·car·di·al/ (-kahr´de-al) 1. situated or occurring within the heart. 2. pertaining to the endocardium. endocardial 1. situated or occurring within the heart. 2. diagnostics and therapy, Monday reported its 5 French (5F) small dome deflectable de·flect intr. & tr.v. de·flect·ed, de·flect·ing, de·flects To turn aside or cause to turn aside; bend or deviate. [Latin d catheter and 4F and 5F fixed catheters have received market clearance by the 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. ) for pediatric use. Biosense Webster is a Johnson & Johnson company. This regulatory clearance allows the specified diagnostic catheters to be used in the electrophysiology mapping of cardiac structures for children four years of age and older. In combination with the CELSIUS(TM) line of ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. catheters, which received Pre-Market Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) for pediatric use in February 1999, this approval gives Biosense Webster the distinction of being the only company to offer electrophysiologists both diagnostic and therapeutic catheters cleared for pediatric use. Roy Tanaka, president, Biosense Webster, said: "Biosense Webster has always been committed to the pediatric community. By receiving this market clearance, we're able to further our commitment by providing pediatric electrophysiologists with a choice of versatile catheters to meet all of their needs. "In addition, this newest marketing clearance is consistent with the values and dedication to pediatrics set forth in the early years of our company by Will Webster, the founder of Webster Laboratories." Biosense Webster plans to use the market clearance as a platform to expand both its fixed and deflectable catheter lines with products designed specifically for the pediatric anatomy. About Biosense Webster, Inc. Biosense Webster continues to advance the state of the art in endocardial diagnostics and therapy through technical innovation and a dedication to quality craftmanship. Biosense Webster is recognized worldwide for its development of advanced cardiac catheter cardiac catheter n. A long, fine catheter that can be passed into the chambers of the heart via a vein or artery as a means of withdrawing samples of blood, measuring pressures within the heart's chambers or great vessels, or injecting contrast media. designs. The company is a pioneer in three-dimensional cardiac mapping and navigation systems A GPS-based electronic system in a car or truck that provides a real time map of the vehicle's current location as well as step-by-step directions to a programmed destination. See GPS and vehicle tracking. that provide both electrophysiologists and cardiologists valuable information for disease evaluation and therapy. Combining cutting-edge technology and expertise, Biosense Webster offers a unique resource for cardiac physicians, one that is dedicated to providing innovative and reliable solutions to optimize patient outcomes. Biosense Webster is a member of the Johnson & Johnson worldwide family of companies marketing health care products in more than 175 countries. Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products. For more information on Biosense Webster, call 800/729-9010 or visit www.biosensewebster.com. Note to Editors: CELSIUS is a trademark of Biosense Webster, Inc. All other trademarks and registered trademarks are the property of the companies with which they are associated. |
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