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原文:
The Edwards SAPIEN XT transcatheter valve enables doctors to replace failing aortic valves without major surgery. The leaflet design of this new valve is modeled after Edwards' clinically proven aortic tissue valves and its cobalt chromium frame provides improved radial strength and, therefore, Automatic Control Valves
enhanced circularity. The Edwards SAPIEN XT valve with the NovaFlex transfemoral delivery system is designed to provide easy, precise, balloon-expandable delivery of the valve.
"The Edwards SAPIEN XT valve platform offers best-in-class valve performance with a low-profile delivery system," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve replacement. "We are excited about the new platform and our continued leadership in this transformational technology."
As heart teams continue to gain clinical experience with the Edwards SAPIEN XT valve on the Ascendra 2 transapical delivery system, Edwards will begin introducing that system commercially in Europe during the second quarter. The Ascendra 2 system features a reduced profile and is designed for improving ease-of-use when delivering the valve through a small incision between the ribs.
The Edwards SAPIEN XT valve is the second commercially available transcatheter valve in the Edwards SAPIEN product portfolio. Edwards is the only company to commercialize both transfemoral and transapical transcatheter aortic valve systems, which have been available in Europe since 2007. In the United States, the Edwards SAPIEN valve is an investigational device being studied as part of the world's Check Valves
only randomized, pivotal clinical trial of a transcatheter aortic valve and not yet available commercially.
About Edwards Lifesciences Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company's global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz.
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 include, but are not limited to, the timing and progress of clinical studies relating to the company's transcatheter valve technologies and the market opportunity for transcatheter 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 Safety Valves
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, Ascendra 2, Edwards SAPIEN XT and NovaFlex are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, the stylized E logo, Ascendra, Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, Magna, PERIMOUNT Magna and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.
原文来自:http://www.marketwatch.com/story/edwards-sapien-xt-transcatheter-valve-and-delivery-systems-receive-ce-mark-2010-03-02?reflink=MW_news_stmp
Edwards SAPIEN XT Transcatheter Valve and Delivery Systems Receive CE Mark;是由 上海赛泰泵阀有限公司提供的阀门新闻,中文译文仅供参考(上海赛泰泵阀有限公司还生产
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以下是参考译文:
译文:爱德华兹SAPIEN导管阀门
该公司正开始一个新的阀门纪律和欧洲推出的18个法国NovaFlex传递系统,并将进一步扩大利用整个系统今年商业用地数量。
爱德华兹SAPIEN xT配对的肝阀使医生能够取代无效的情况下大手术主动脉瓣。这一新的瓣叶的设计是模仿爱德华兹的临床证明主动脉瓣膜组织和钴铬框架提供了改进的径向力,因此,增强圆。 xT配对的爱德华兹SAPIEN与NovaFlex经股传递系统阀门的设计,提供方便,准确,气球的膨胀阀交付。
说:“爱德华兹SAPIEN xT配对阀平台提供最佳的性能级阀门低调的配送体系,”伍德说,拉里湖,爱德华兹的公司副总裁,经导管瓣膜置换。 “我们很高兴新的平台,我们在这一变革性的技术领导地位。”
随着心脏队继续获得与爱德华兹SAPIEN xT配对的Ascendra 2 transapical交付系统阀门的临床经验,爱德华兹将开始在欧洲引进这一系统的商业在第二季度。该Ascendra 2系统功能降低姿态,以及改进的易用性时,可通过肋骨之间的小切口阀门使用而设计。
xT配对的爱德华兹SAPIEN阀是第二个在商用产品组合爱德华兹SAPIEN导管阀门。爱德华兹是唯一一家既商业化和transapical导管经股主动脉瓣系统,并已在欧洲市场自2007年。在美国,爱德华兹SAPIEN阀是一种调查装置的一部分被作为世界上唯一的随机,关键的导管主动脉瓣的临床试验,还没有从商业的影响。
关于爱德华生命科学爱德华生命科学是在心脏瓣膜和血流动力学监测科学的全球领导者,拥有五年以上,与临床医生合作开发救生创新几十年的经验。在加利福尼亚州欧文,爱德华兹与总部设在对待先进的心血管疾病的市场领先的心脏瓣膜疗法,护理和血管的关键技术,在大约100个国家销售。该公司的全球品牌包括卡彭铁尔,爱德华兹,科斯格罗夫,爱德华兹,爱德华兹SAPIEN,FloTrac,福格蒂,PERIMOUNT麦格纳和Swan - Ganz导管。更多的公司信息,
本新闻稿包含前瞻性内科的节和1933年证券交易法21E小节的1934年证券法27A表述。这些前瞻性声明包括但不仅限于,时机和临床有关的公司的导管阀门技术的研究和导管技术的市场机会的进展。前瞻性声明是基于估计和公司的管理作出的假设,并认为是合理的,虽然他们本身具有不确定性和难以预料的。我们的前瞻性陈述仅作为对它们作出不承担任何义务更新任何前瞻性声明以反映事件或之后的发言和情况的日期。
前瞻性陈述涉及风险和不确定性可能导致实际结果或经验大不相同的是表达或前瞻性陈述中所暗示。上述因素可能导致实际结果或经验大不相同的是表达或前瞻性陈述中详细说明与证券交易委员会的年度报告10公司提交的文件中,截至12月31日K年度暗示, 2009。
爱德华兹Ascendra 2,爱德华兹SAPIEN XT和NovaFlex是爱德华生命科学公司的商标。爱德华生命科学的程式化的标志,Ascendra,卡彭铁尔,爱德华兹,科斯格罗夫,爱德华兹,爱德华兹SAPIEN,FloTrac,福格蒂,麦格纳,PERIMOUNT麦格纳和Swan - Ganz导管是爱德华生命科学公司的商标,并在美国专利和商标注册办公室。
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