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Thomas, a cardiologist at St. Thomas’ Hospital in London, fixes diseased heart valves in a way that allows patients to avoid open-heart surgery. The technique employs devices made by Medtronic Inc. of Minneapolis and Edwards Lifesciences Corp., based in Irvine, California. The two companies are racing to bring the technology to the U.S., the key to a worldwide market Medtronic says may top $2 billion annually within five years. 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 Clinic. “This is a lethal condition, with a 50 percent annual mortality rate,” Thomas said. “The real skill, especially at this early stage, is picking a patient who will survive the procedure and then will also thrive.” European Union regulators, who set rules for 27 countries, cleared the devices from Edwards and Medtronic in 2007. The valves may generate $200 million in sales this year in Europe, the only place where they are approved, according to forecasts from Medtronic and Edwards. The world market will be larger, the companies say. Market Opportunity “There is no doubt this is a $2 billion to $2.5 billion market in the population we have today,” mainly patients older than 75 and others who couldn’t tolerate open-heart surgery, ten Hoedt of Medtronic said in an interview. “If we go younger, to age 65, that market opportunity will grow exponentially.” 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. Relieving Symptoms With aortic stenosis, the heart struggles to pump, causing pain, fainting and heart failure, according to the U.S. National Institutes of Health, based in Bethesda, Maryland. Four percent of octogenarians have the condition, and the number of patients will continue to grow as the population ages, Thomas said. The recovery period with the minimally invasive approach is easier, with patients typically walking within a day of surgery and returning to normal life without months of rehabilitation, doctors said. There are 254,000 aortic valves replaced worldwide each year, including 105,000 in Europe, according to Toronto-based Millennium Research Group. Almost one in 10 European patients now gets the new aortic valves, said Larry Biegelsen, an analyst at Wells Fargo Securities LLC in New York. About 40 percent of all aortic valve replacements may be done without chest-cracking surgery by 2014, he said in a telephone interview. The procedure requires cooperation between half a dozen interventional cardiologists, heart surgeons, anesthesiologists and imaging experts, plus nurses and technicians to get the valve positioned correctly. Cardiac surgeons, who cut open the chest, participate in each operation at St. Thomas. So do their traditional rivals, the interventional cardiologists who work through small incisions. 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 groin up to the heart. The new valves cost about $25,000, about five times the price of the traditional models. The price takes into account the cost of developing a new technology and the training and supervision needed when physicians first start doing the procedure, Edwards’s Wood said. The first year the devices were sold in Europe, a company specialist was present to assist at each operation, he said. Speedier Surgery 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安全阀呼吸阀减压阀针型阀调节阀 < 及电动对夹硬密封蝶阀，真空蝶阀，电动调速蝶阀，氧气截止阀，气动对夹硬密封蝶阀，欢迎您的选购。)
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译文：医学阀门死亡率
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。 '致死条件' 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。” 欧盟监管，谁为27个国家的规则，清理2007年美敦力公司的爱德华兹和设备。阀门可能会生成美元的销售额2.0亿，今年在欧洲，唯一的地方，也获得批准，根据预测，从美敦力和爱德华兹。世界市场将更大，该公司说。市场机会 “毫无疑问这是一个人口我们今天二十万点零零零万美元至25亿美元的市场，”主要是75岁以上的病人和其他人谁也不会容忍心内直视手术，10美敦力Hoedt在接受采访时说。 “如果我们年轻，年龄65岁，该市场的机会将会成倍增加。” 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治疗病情加重的病人。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。缓解症状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。与微创方法回收期更轻松，通常在手术一天走动的病人，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。心操纵让患者接受心脏阀门操纵加快跳动，挤掉血液，托马斯说。这个过程可以更容易地位置无需停止心脏，加重心脏的病人，肺体外循环机在现有的瓣膜置换前，他说。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。 '沉睡的市场' “这是一个沉睡的市场之前，”Biegelsen说。 “经导管技术是拓展市场。” 该程序要求之间的合作半打介入心脏病，心脏外科，麻醉科和影像专家，加上护士和技术人员获得正确定位的阀门。心脏外科医生，谁剖开胸部，参与每一个操作在圣托马斯。因此，与其传统的对手，谁通过小切口工作介入心脏病。外科医生通常会监督时，缝之间的肋骨和心脏所作的操作，迎面插入阀门。关闭的穿刺像一个袋子，与拉带针，医生都制定手术前。介入心脏病导致阀门时，是通过在腹股沟动脉直至心脏线程的方式。新的阀门费用约25,000元，约5倍价格的传统模式。价格考虑到开发新技术和必要的培训和监督，第一次启动时，医生做的程序，爱德华兹的木材成本说。第一年的设备是在欧洲销售，该公司专家出席会议，以协助在每次行动，他说。加快手术该做的程序的全部费用，包括在医院恢复时间，很可能是对美国作为传统业务的同时，伍德说。虽然阀门成本，更快捷的手术结果，如心脏，减少对其他设备的需要，肺旁路机，在医院少天，他说。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。股权投资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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