当前位置: 首页 valve news Lifesavers, with a business benefit

Lifesavers, with a business benefit

原文:
AThe last time Dan Matthys had major surgery to repair a recurring heart valve problem, he nearly died on the table. Matthys was 18 years old, and the situation was Butterfly Valves so dire that doctors urged his friends and family — including a sister who was away in France — to quickly assemble at a Texas hospital to say goodbye.
Somehow, Matthys survived that surgery in 1990. But the experience made him deeply reluctant when doctors recommended another valve repair surgery a few years ago.
In the end, Matthys was able to avoid an open-heart procedure thanks to an experimental valve treatment from Fridley-based Medtronic. He received the device last year as part Globe Valves of a study, and then testified before an advisory committee at the Food and Drug Administration this summer to urge approval for the product, called the Melody Transcatheter Pulmonary Valve.
'The procedure Safety valves has not only improved my quality of life physically, but in a large part psychologically, as well,' said Matthys, 37, of North Carolina, during his FDA testimony.
'It is not easy to imagine the intense fear that my family and I were going through when we thought we had no other option than to face another open-heart surgery,' said Matthys, who disclosed that he owns Medtronic stock and was traveling on the company's dime.
In July, the advisory committee recommended that FDA approve the Melody valve for use in the U.S. under what's called a humanitarian device exemption. If the agency approves
原文来自:http://www.twincities.com/business/ci_13318505?nclick_check=1

以下是参考译文:

译文:
上一次丹Matthys了相当大的手术,修复心脏瓣膜的问题反复出现,他几乎死在桌子上。 Matthys是18岁,形势非常糟糕,医生要求他的朋友和家人-包括一个妹妹谁身在法国-迅速在得克萨斯州医院组装说再见。 不知何故,Matthys幸存,1990年手术。但是,经验使他非常不愿意再当医生建议瓣膜修复手术几年前。
最后,Matthys能够避免心脏直视程序由于从弗里德利试验阀治病的美敦力。他收到的设备,去年,作为研究的一部分,然后作证一个咨询委员会,美国食品和药物管理局今年夏天,敦促该产品的批准,被称为旋律经导管肺动脉瓣。
'的过程,不仅提高了我身体的生活质量,但在很大程度上是心理上的,而且,'说Matthys,北卡罗来纳州37,他在美国FDA的证词。 '这是不容易的想象,强烈的恐惧,我的家人和我的经历,当我们认为我们没有别的选择,只有继续面对另一次心脏手术,'说Matthys,谁透露,他拥有美敦力公司的股票,并在旅行该公司的一分钱。
今年7月,咨询委员会建议,美国FDA批准在美国使用,在什么叫做人道主义装置豁免旋律阀。如果该机构批准