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Edwards Lifesciences lance la valve Magna Mitral Ease


News provided by

Edwards Lifesciences

Sep 15, 2010, 04:00 ET

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GENEVA, Suisse, September 15, 2010 /PRNewswire/ --

- Les données préliminaires sur la plate-forme de valve aortique Odyssey mettent en évidence des bénéfices peropératoires avec un déploiement rapide de la valve

Edwards Lifesciences Corporation (NYSE:EW), le leader mondial des valves cardiaques et de la surveillance hématologique, a annoncé aujourd'hui le lancement aux États-Unis et dans l'Union Européenne de sa valve Carpentier-Edwards PERIMOUNT Magna Mitral Ease, conçue pour faciliter la mise en place au niveau mitral d'accès particulièrement difficile à l'intérieur du coeur. Le lancement se déroulera lors du 24e Congrès annuel de l'Association européenne de chirurgie cardiothoracique (European Association for Cardio-Thoracic Surgery, EACTS).

La valve Magna Mitral Ease intègre de nouvelles caractéristiques qui facilitent l'accès, la mise en place et la suture au cours des chirurgies conventionnelles de remplacement des valves cardiaques ou des procédures mini-invasives, en particulier avec thoracotomie. Toutes les améliorations apportées au produit, par exemple un support à trois couleurs, un guide de suture unique, une large collerette en forme de selle et de nouveaux accessoires, sont toutes conçues pour faciliter la mise en place par le chirurgien. La valve Magna Mitral Ease repose sur la structure clinique éprouvée et durable de la valve mitrale Edwards PERIMOUNT, qui dispose de plus de 250 000 années-patients d'expérience à travers le monde. Les patients porteurs de valves tissulaires, comme Magna Mitral Ease, montrent un besoin réduit de prescription permanente d'anticoagulants, et sont par conséquent moins exposés à leurs risques et effets indésirables.

<< La valve Magna Mitral Ease peut nous aider à obtenir une amélioration dans la prise en charge des patients, en maintenant les excellents paramètres hémodynamiques du modèle précédent, tout en améliorant et en simplifiant la mise en place de la nouvelle valve mitrale >>, a déclaré le professeur Jan Gummert, de l'Hôpital universitaire de l'Université de Bochum (Ruhr, Allemagne). La clinique de l'Université de la Ruhr a été la première dans le monde à mettre en place la valve Magna Mitral Ease en utilisant une procédure de thoracotomie mini-invasive.

Lors du TechnoCollege de l'EACTS qui s'est tenu le 11 septembre 2010, le docteur Malakh Shrestha, de l'École médicale d'Hanovre, (Hanovre, Allemagne) a effectué une présentation préliminaire d'une série unicentrique de cas d'implantation mini-invasive de la plate-forme expérimentale de valve aortique Odyssey à déploiement rapide d'Edwards. Cette série initiale de procédures de remplacement valvulaires aortiques, qui s'est déroulée à Hanovre en utilisant la plate-forme Odyssey, a montré une réduction d'environ 50 % des durées de circulation extracorporelle et de clampage par rapport à une chirurgie conventionnelle isolée de remplacement de la valve aortique. La plate-forme Odyssey fait actuellement l'objet d'investigations en Europe dans le cadre de l'étude TRITON, et des données supplémentaires sont attendues après la fin de l'inclusion et du suivi des patients.

<< La plate-forme Odyssey est conçue pour simplifier et faciliter la procédure mini-invasive de remplacement de la valve aortique, permettant ainsi de réduire les durées de circulation extracorporelle grâce à sa méthode unique de mise en place. Nous pensons que ces perfectionnements procéduraux peuvent également améliorer les résultats chez les patients >>, a indiqué Donald E. Bobo, Jr., vice-président du groupe Edwards, remplacement des valves cardiaques.

Le professeur Gummert et le docteur Shrestha fournissent des services rémunérés à la société Edwards Lifesciences pour des programmes de formation.

À propos de la valve Carpentier-Edwards PERIMOUNT Magna Mitral Ease

La valve cardiaque Carpentier-Edwards PERIMOUNT Magna Mitral Ease est un dispositif bioprothétique à base de tissus péricardiques destinés aux patients nécessitant un remplacement des valves cardiaques mitrales lésées. Elle est basée sur la structure de la valve mitrale Edwards PERIMOUNT. De multiples études ont démontré la résistance à long terme de la valve PERIMOUNT Magna Mitral.

À propos de Edwards Lifesciences

Edwards Lifesciences est le leader mondial dans le domaine des valves cardiaques et de la surveillance hémodynamique. Mue par sa passion d'apporter de l'aide aux patients, la société établit des partenariats avec des cliniciens pour développer des technologies innovantes dans les domaines des pathologies cardiaques structurales et de la surveillance en soins intensifs permettant de sauver et d'améliorer leur vie. Des informations supplémentaires sur la société se trouvent à l'adresse suivante : http://www.edwards.com.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "expect," "intend," or other similar expressions and include, but are not limited to, the timing and progress of clinical studies relating to the company's heart valve technologies and the market opportunity for these technologies. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2009.

Edwards, Magna Mitral Ease et Odyssey sont des marques de commerce d'Edwards Lifesciences Corporation. Edwards Lifesciences, le logo en E stylisé, Carpentier-Edwards, Magna, PERIMOUNT et PERIMOUNT Magna sont des marques de commerce d'Edwards Lifesciences Corporation et sont enregistrées au Bureau des brevets et des marques commerciales des États-Unis (United States Patent and Trademark Office).

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