BIOTRONIK Announces FDA Approval and First Implant of the Linox SD Lead.PORTLAND, Ore. -- BIOTRONIK, Inc. today announced 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. ) approval and the first implant of the newest member of the BIOTRONIK Implantable Cardioverter Defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. ) lead family-the Linox SD active fixation, steroid-eluting lead. The Linox SD incorporates a slim 7.8 French isodiametric isodiametric measuring the same in all diameters. lead body, an advanced helix mechanism, and two color-coded DF-1 connectors. Linox SD also features BIOTRONIK's exclusive fractal technology for improved sensing performance and a steroid-eluting collar to control acute threshold increases. "The Linox SD lead represents another significant advancement in our implantable lead technology, which is already known for its superior reliability," states Jake Langer, President of BIOTRONIK, Inc. "The innovation and efficiency offered by this lead exemplifies a company philosophy aimed at optimizing patient therapy within the Cardiac Rhythm Management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. (CRM (Customer Relationship Management) An integrated information system that is used to plan, schedule and control the presales and postsales activities in an organization. ) industry." The first U.S. implantation of Linox SD was performed at Riverview Regional Medical Center in Gadsden, Alabama by Dr. B.J. Patel on April 10, 2006. Dr. Patel was very pleased with the agility and handling characteristics of this new lead, as well as its low threshold numbers. Dr. Patel commented: "BIOTRONIK's Linox SD easily went through an 8F introducer, and its helix is clearly visible under the fluoroscope fluoroscope (fl  r`əskōp), instrument consisting of an X-ray machine (see X ray) and a fluorescent screen that may be used by physicians to view the internal organs of the body. . It is definitely one of the best performing ICD leads on the market." BIOTRONIK also recently received FDA approval for the Setrox S active fixation, steroid-eluting bradycardia bradycardia: see arrhythmia. lead. It also features a slim isodiametric profile at 6.7 French with the same advanced helix mechanism and flexible distal tip that provides greater maneuverability for implantation and improved post-implantation results. Both Linox SD and Setrox S offer great mapping capability that allows physicians to identify the optimal implant location prior to extension of the helix. The introduction of these two state-of-the-art implantable cardiac leads continues to enhance BIOTRONIK's extensive CRM product portfolio. BIOTRONIK's U.S. headquarters are located near Portland, Oregon. Founded in 1963, BIOTRONIK today ranks as one of the leading cardiac rhythm management companies, conducting business in over 100 countries worldwide, and providing a full range of innovative cardiovascular products of the highest quality and reliability. BIOTRONIK's motto, "Technology Helping to Heal," is reflected in the company's primary guiding principle: helping patients by researching, developing, and marketing biomedical products to restore, secure, and enhance their quality of life. |
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