原文：
The method may aid as many as 10,000 patients this year in Europe, where regulators allowed the devices on the market without clinical trials for the weakest patients. Doctors there are years ahead of their American counterparts, who must await research results and U.S. approval before using the valves. 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. 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 Clinic. Traditional repair requires surgeons to stop the heart and make an incision running the length of the chest to get access to the valve that controls the flow of oxygen-rich blood to the body. The narrowed and calcified aortic valve is cut out, and a $5,000 replacement is sewn into place. The surgery is effective, with valves lasting 15 years or longer, said Larry Wood, Edwards’s corporate vice president of transcatheter valve replacement. 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 patients treated through the ribs. Surgeons typically oversee the operation when a slit is made between the ribs and the heart is pierced to insert the valve. The puncture is closed like a sack, with drawstring stitches the surgeon puts in place before the procedure. Interventional cardiologists lead the way when the valve is threaded through the artery in the 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 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

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译文：迁移阀门
托马斯一介入心脏病和阀门的先驱，而不是专门设计的线程二万五千元到跳动的心脏瓣膜通过的腿动脉或在小切口肋骨。在某些情况下，直接刺穿心脏是在用空心针尖鼻子，让医生插入导丝和风力，通过机关的商会它。更换阀门，到一个导管轧花，遵循因为它是到位喂丝。 该程序执行了不到5年，离开对手术比较安全和阀门的耐用性，它必须打开和关闭4000.0万次，每年问题。在欧洲的医疗监管机构的行动限制的病人谁不能轻易容忍心内直视手术，以修复其患病的阀门。 “这是一个致命的条件，与百分之五十周年死亡率，”托马斯说。 “真正的技能，特别是在这个早期阶段，正在复苏的病人谁才能生存的过程，然后也将兴旺。” 外科医生仍不能确定的死亡和并发症发生率，包括中风，主动脉破裂，出血和迁移阀门，谁的患者接受的程序。一个注册表跟踪显示，在欧洲的患者在一年后存活了78中获得百分之通过动脉瓣膜病人，百分之五十的肋骨通过xx病情加重的病人。 爱德华兹开始了其在2007年阀门Sapien临床试验，将在对美国市场取得进展，至少提前两年它的主要竞争对手，美敦力的CoreValve。结果可能在明年上市，据爱德华兹的木材。 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。 与微创方法回收期更轻松，通常在手术{yt}走动的病人，没有康复个月恢复正常生活，医生说。 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。

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