Boston Scientific Announces European Approval And Elementary Implants Of Original Defibrillation Heavy System Designed To Simplify The Surgical Process
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Boston Scientific Association (NYSE: BSX) announced CE Stop and the first human implants of the Company's ENDOTAK RELIANCE(R) 4-SITE defibrillation lead system. Defibrillation leads are insulated wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart and, when needed, deliver life-saving therapy.
The ENDOTAK RELIANCE 4-SITE lead transaction is designed to simplify the implant procedure by combining three terminals into one integrated connector, reducing the required implant sphere within the body. This system, combined with the virgin TELIGEN(R) ICD and COGNIS(R) CRT-D, is designed to comply with the forthcoming international connector standard(1). The different criterion will permit product compatibility across manufacturers. The Firm is working with physicians to launch the process in assorted phases with a spotlight on monitoring clinical performance completed robust post-market review enhanced by the LATITUDE(R) Patient Government system(2).
"We are pleased to proclaim CE Location and the first human implants of the ENDOTAK RELIANCE 4-SITE direction system," said Fred Colen, President, Boston Scientific Cardiac Rhythm Management. "This fashionable step represents the following advance for the ENDOTAK RELIANCE vanguard family, which has demonstrated reliability in augmented than 350,000 implants worldwide."
This technology allows the world's smallest, thinnest high-energy ICDs and CRT-Ds to become all the more smaller. The connector reduces the textbook of TELIGEN and COGNIS to 32 cc and 30 cc respectively, while maintaining a thickness of less than 10 mm.
Some models of the ENDOTAK RELIANCE 4-SITE product string point a proprietary GORE(TM) covering designed to prevent tissue ingrowth into the defibrillation coils, without compromising the electrical performance of the lead. The ENDOTAK RELIANCE G model is the lone defibrillation lead on the mart to address tissue ingrowth using this innovative approach. Preventing tissue ingrowth assists physicians with the long-term governance of slogan patients. Although rare, advance emigration is sometimes necessary. Studies retain shown that the proprietary covering helps physicians perform this procedure enhanced easily and effectively.
The implants were performed under the leadership of the succeeding physicians:
-- Oliver Przibille, M.D., Cardioangiolisches Centrum Bethanien, Frankfurt, Germany
-- Hans-Joachim Trappe, M.D., Marienhospital Herne Klinikum der Ruhr-Universitat Bochum, Herne, Germany
-- Johannes Heintze, M.D., Herz und Diabeteszentrum Nordrhein-Westfalen Malicious Oeynhausen, Bad Oeynhausen, Germany
-- Lieselot van Erven, M.D., Leiden University Medical Center, Leiden, The Netherlands
Cautionary Statement Regarding Forward-Looking Statements
This press proceeds contains forward-looking statements within the meaning of Chop 21E of the Securities Alternate Point of 1934. Forward-looking statements may be identified by passage affection "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and congruent words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our product performance, regulatory approval of our products, new product launches, competitive offerings, our growth strategy, and our position. Provided our underlying assumptions turn outside to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the forthcoming (together with other factors) could involve our capability to appliance our line strategy and may goal actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may agency such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; mental property; litigation; financial marketplace conditions; and, imminent employment decisions false by us and our competitors. All of these factors are exacting or impossible to predict accurately and many of them are beyond our control. For a also list and discription of these and other influential risks and uncertainties that may affect our eventual operations, peep Part I, Thing 1A- Risk Factors in our most original Annual Report on Form 10-K filed with the Securities and Replace Commission, which we may update in Factor II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or testament string thereafter. We disclaim any reason or debt to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
(1) International Organization for Standardization (ISO) IS-4/DF-4 standard.
(2) The Meridian Patient Management system is not all the more approved in Europe.
Source: Boston Scientific Corporation
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