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原文:
Medtronic fell 18 to $36.02 at 4 p.m. in New York Stock Exchange composite trading and has fallen 33 percent in the past 12 months. Edwards fell $1.12, or 1.7 percent, to $63.81 and gained less than 1 percent in the past year.
The U.S. Food and Drug Administration will make approval contingent on a study to prove the valves are at least as effective, and as safe, as traditional care. Balance Valves
Doctors in the U.S. recognize the FDA’s need for caution, said Murat Tuzcu, an interventional cardiologist and vice chair for clinical operations at the Cleveland
The procedure has been performed for less than five years, leaving questions about the comparative safety of the surgery and the durability of the valve, which must open and close 40 million times a year. Medical regulators in Europe limit the operation to patients who can’t easily tolerate open-heart surgery to repair their diseased valves.
Surgeons are still unsure of the death and complication rates, including strokes, aortic rupture, bleeding and migrating valves, in patients who undergo the procedure. A registry tracking patients in Europe showed a 78 percent survival after one year in patients getting the valve through an artery, and 50 percent for sicker patientsInstrumentation Ball Valves treated through the ribs.
Edwards began a clinical trial of its Sapien valve in 2007, putting it at least two years ahead of its main rival, Medtronic’s CoreValve, in progress toward the U.S. market. The results may be available next year, according to Edwards’s Wood.
The complete cost of doing the procedure, including the recovery time in the hospital, is likely to be about the same in the U.S. as for traditional operations, Wood said. While the valve costs more, it results in speedier surgery, less need for Balance Valves
other equipment such as heart-lung bypass machines, and fewer days in the hospital, he said.
U.S. regulators are “going to want to know that these valves last for 10 years, as the surgically implanted valves do,” James Tobin, who retired in July as chief executive officer of Natick, Massachusetts-based Boston Scientific, said in an interview. “Our position is, let’s hold our fire on the first-generation stuff and wait until the better solutions are at hand.”
原文来自: http://www.bloomberg.com/apps/news?pid=20601124&sid=ayZVJl83Srd4
Hearts Get Gentle Touch With Medtronic, Edwards Valve (Update2);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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译文:阀门植入手术
该程序为病人解除谁不符合传统的操作症状,托马斯说。研究人员正在研究是否将延长生命和减少帮助患者避免重复病情严重住院后的医疗费用,他说。
随着主动脉瓣狭窄,心脏泵的斗争,导致疼痛,眩晕,心脏衰竭,根据美国国家卫生研究院,在马里兰州贝塞斯达的基础。四有百分之八十岁的老人的条件,和患者的人数将继续增长,因为人口老化,托马斯说。
有254,000瓣膜替换每年在世界各地,包括欧洲10.5万,据总部设在多伦多的千年研究小组。几乎在10个欧洲一个病人现在获取新的主动脉瓣,拉里Biegelsen说,一个富国银行证券公司驻纽约的分析师。约百分之四十的主动脉瓣置换可采取无胸痛,到2014年手术打击,他在接受电话采访。
一项研究,在美国心脏病学院杂志刊登5月,显示了新的设备将帮助心脏泵出的比老的有缝模型到位更多的血液。改善会从一个较新的阀门内,而没有一个内部环需要的地方举行大型开幕式的针干说,爱德华兹的木材。
作为医生详细了解较少繁重的治疗选择,他们派遣了心脏病,托马斯和其他医生的评价更多的患者说。在欧洲的主动脉瓣程序,增长了9比去年同期,大约3倍于正常的速度,Wachovia的Biegelsen说。
阀门是第一代使用较少的侵入,导管为基础的方法。在发展其他设备可以更方便地插入和操纵,使医生在重新定位,而目前这些设备的程序不能移动后安装。
波士顿科学公司作出的股权投资,不公开披露的数额,在萨德拉医疗,一人持股公司创建于2003年加利福尼亚州的坎贝尔。萨德拉正在开发一个系统,主动脉瓣莲花,可以通过植入循环系统和重新定位,需要众所周知的。
美国监管机构是“会想知道,这些阀门的最后10年,随着阀门植入手术做,”托宾,谁在7月退休,担任马萨诸塞州Natick郡,首席执行官的波士顿科学公司,在接受采访时说。 “我们的立场是,我们举行了第一代的东西消防车和等待更好的解决方案在交给我们。”
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