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Les defibrillateurs de Boston Scientific obtiennent le marquage CE pour leur longevite etendue

PARIS, November 20, 2012 /PRNewswire/ --

La longévité attendue pour ces dispositifs est deux fois plus étendue que celle de produits similaires

Boston Scientific Corporation (NYSE : BSX) vient d'obtenir une modification de marquage CE en reconnaissance de l'extension de longévité de ses défibrillateurs automatiques implantables (DAI) et défibrillateurs avec fonction de resynchronisation cardiaque (CRT-D) INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® et TELIGEN®. Les prévisions de longévité reposent sur des données soumises aux autorités européennes et varient pour chaque dispositif en fonction du modèle et des configurations.

La longévité attendue pour ces dispositifs est de plus de 10 ans pour certains modèles de DAI de Boston Scientific et avoisine huit ans pour les CRT-D, soit une longévité pouvant aller jusqu'au double de celle de dispositifs similaires concurrents.[1] La société propose ces dispositifs avec des garanties pouvant aller jusqu'à 10 ans selon les modèles*, c'est-à-dire des durées de garantie jusqu'à deux fois plus longues que celles d'autres dispositifs similaires actuellement disponibles sur le marché.   

« Nous sommes très heureux de cette mise à jour de nos mentions légales, qui permet d'offrir aux médecins et aux patients une assurance supplémentaire sur la longévité de nos dispositifs » a déclaré Michael Onuscheck, Vice-Président de Boston Scientific et Président de Boston Scientific Europe, Moyen-Orient et Afrique. «  Les DAI et les CRT-D de Boston Scientific bénéficient de notre technologie innovante et exclusive en termes de batterie. Cette nouvelle pile a été tout d'abord introduite pour les dispositifs COGNIS et TELIGEN, en 2008, et elle est désormais intégrée à tous nos nouveaux dispositifs. Cette certification européenne confirme la confiance déjà exprimée par la Food and Drug Administration des États-Unis en début d'année. »

« La longévité des dispositifs est essentielle pour les patients implantés par ces dispositifs. Les patients vivant plus longtemps, l'amélioration de la longévité peut se traduire très concrètement par une diminution du nombre de procédures de remplacement et du risque de complications »  a ajouté Vias Markides, cardiologue consultant et président du département d'arythmie du Royal Brompton and Harefield NHS Foundation Trust, à Londres, Royaume Uni. « La diminution du nombre de procédures de remplacement exerce également un impact important en termes économiques pour les systèmes de santé, en permettant de faire des économies substantielles et en offrant des avantages opérationnels aux services d'implantation de dispositifs. Les DAI et les CRT-D de Boston Scientific ont montré une amélioration significative des estimations de leur longévité, étayée par une garantie offerte par la société avec une durée impressionnante. »

*Garanties : DAI INCEPTA et ENERGEN VR :10 ans ; DAI INCEPTA et ENERGEN DR : huit ans ; DAI PUNCTUA et TELIGEN : sept ans ; CRT-D INCEPTA et ENERGEN : six ans ; CRT-D PUNCTUA & COGNIS : cinq ans.

1. DAI PUNCTUA™ , DAI ENERGEN™, DAI INCEPTA™ - MANUEL TECHNIQUE DU MÉDECIN
No de référence : 358362-006, 5-22-12 ; TELIGEN® 100 - MANUEL TECHNIQUE DU MÉDECIN
No de référence : 357449-010, 5-22-12 ; CRT-D PUNCTUA™, CRT-D ENERGEN™, CRT-D INCEPTA™ - MANUEL TECHNIQUE DU MÉDECIN No de référence : 358373-007, 5-22-12 ; COGNIS® 100-D -MANUEL TECHNIQUE DU MÉDECIN No de référence : 357483-012, 5-22-12

Le lien suivant donne accès à du matériel multimedia tel que video, informations et images :

http://www.epresspack.net/bsci

Visitez le site de Boston Scientific Longévité: http://www.bostonscientific-international.com/ICDlongevity

À propos de Boston Scientific

Boston Scientific est une société d'envergure mondiale qui développe, fabrique et commercialise des dispositifs médicaux utilisés dans un vaste éventail de spécialités médicales interventionnelles. Pour plus d'informations, rendez-vous sur le site http://www.bostonscientific.com.  

Mise en garde concernant les déclarations prévisionnelles

Ce communiqué de presse contient des déclarations prévisionnelles au sens de la Section 27A du Securities Act de 1933 et de la section 21E du Securities Exchange Act de 1934. Ce communiqué de presse contient des déclarations prévisionnelles qui peuvent être identifiées par l'emploi de termes tels qu'anticiper, prévoir, projeter, croire, programmer, estimer, avoir l'intention de et d'autres termes similaires. Ces déclarations prévisionnelles se fondent sur nos croyances, hypothèses et estimations, lesquelles emploient les informations que nous avons à notre disposition au moment concerné, et ne doivent pas être considérées comme des garanties d'événements ou de performances futurs.   Ces déclarations prévisionnelles incluent, entre autres, des déclarations concernant notre stratégie de croissance, les commercialisations de nouveaux produits et le rythme des commercialisations, les performances de nos produits et les offres concurrentes. Dans le cas où nos hypothèses se révèleraient inexactes, ou si certains risques ou incertitudes venaient à se matérialiser, les résultats effectifs pourraient sensiblement varier par rapport aux attentes et aux projections exprimées ou suggérées par nos déclarations prévisionnelles. Dans certains cas, ces facteurs ont altéré et pourraient altérer à l'avenir (avec d'autres facteurs) notre capacité à mettre en œuvre notre stratégie d'entreprise, et pourraient entraîner une divergence significative des résultats effectifs par rapport à ceux visés par les déclarations prévisionnelles de ce communiqué de presse. En conséquence, nous mettons en garde le lecteur afin qu'il ne place pas une confiance excessive dans l'une de nos déclarations prévisionnelles.  

Parmi les facteurs pouvant provoquer de telles différences figurent : les futures conditions économiques, concurrentielles, de remboursement et réglementaires, l'introduction de nouveaux produits, les tendances démographiques, la propriété intellectuelle, les litiges, la situation du marché financier et les futures décisions professionnelles prises par notre entreprise ou nos concurrents.  Il est difficile, voire impossible, de prédire l'ensemble de ces facteurs de manière précise, et la plupart d'entre eux échappent à notre contrôle.  Pour obtenir une liste et une description de ces facteurs ainsi que des autres risques et incertitudes importants pouvant altérer nos futures opérations, reportez-vous à la partie I, article 1A : Facteurs de risque de notre dernier rapport annuel figurant sur le Formulaire 10-K déposé auprès de la Commission américaine des valeurs et des changes (SEC), qu'il est possible de nous actualisions dans la partie II, article 1A : Facteurs de risque dans les rapports trimestriels sur le Formulaire 10-Q que nous avons déposé ou que nous allons déposer ultérieurement. Nous déclinons toute intention ou obligation de mettre à jour ou réviser publiquement toute déclaration prévisionnelle pour qu'elle tienne compte de toute modification de nos attentes ou des événements, conditions ou circonstances à la base de ces attentes ou induisant des résultats effectifs différents de ceux contenus dans les déclarations prévisionnelles. Cette mise en garde est applicable à l'ensemble des déclarations prévisionnelles contenues dans le présent document.

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