FDA clears new family of Medtronic pacemakers for United States marketing.MINNEAPOLIS--(BUSINESS WIRE)--Nov. 8, 1995--Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ), announced today that the U.S. Food and Drug Administration has cleared for commercial release a new family of four new cardiac pacemakers, the Medtronic Thera(R) "i-series". Representing Medtronic's responsiveness to physicians' requests, the new pacing systems address a broad range of clinical challenges. The Thera "i-series" builds on the strength of the Thera pacemaker family, currently the most-prescribed pacemakers in the world, which were released in the United States last January. At equivalent settings, the Thera-i pacemakers deliver significantly more service life in a size comparable to that of their predecessors and with a new, easier-to-implant shape. Used with the company's advanced CapSure(R) Z pacemaker leads, the new pacing systems are the most cost-efficient in Medtronic's history. William W. George William W. George, author of National Best Sellers True North and Authentic Leadership, is professor of Management Practice at Harvard Business School,and former Chairman and Chief Executive Officer (CEO) of Medtronic. , president and chief executive officer, noted that the advanced Thera-i pacemakers were introduced only 10 months after U.S. release of the Thera family. "Medtronic's ability to be responsive to customer needs is a result of our continued commitment to, and investment in, research and product innovation. This improved capability, along with acceleration of 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. regulatory process, allows us to quickly respond to the needs of physicians and their patients." The Thera-i family will be on display as physicians from around the world gather for the annual scientific sessions of the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. November 11-14 in Anaheim, CA. The new pacemakers redefine product superiority in the bradycardia bradycardia: see arrhythmia. pacing market. Expansion of capabilities for treatment of atrial arrhythmias and time-efficient diagnostic and follow-up tools are some of the ways the new pacing system adds value for pacemaker patients. The flagship product is the Thera DR "i-series". This dual chamber, rate responsive pacemaker provides a wide range of flexibility and automaticity for efficient and effective pacing therapy. Also released are the new Thera D, Thera SR and Thera S "i-series" products, which complete a range of products providing flexibility to prescribe the most appropriate therapy for every patient and respond to changes in the physical condition of the patient over time. All have received the CE Mark of the European Community, and have been commercially released in Europe and Canada. Medtronic, Inc., headquartered in Minneapolis, is the world's leading therapeutic medical technology company. CONTACT: Dale Beumer Investor Relations Investor relations The process by which the corporation communicates with its investors. 612/574-3038 or Dick Reid Public Relations public relations, activities and policies used to create public interest in a person, idea, product, institution, or business establishment. By its nature, public relations is devoted to serving particular interests by presenting them to the public in the most 612/574-3052 |
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