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安全问题影响支架生产商

分类: 医务英语 

Stent Makers Hurt by Reports About Safety

安全报告打击血管支架生产商

Shareholder qualms about growth prospects for the $5 billion coronary stent business yesterday shook the stocks of Boston Scientific and Johnson & Johnson, the two leading stent makers.

昨天(9月7日),股东们的对心血管支架未来有五十亿美元的增长空间表示疑虑,这使两家主要的血管支架生产商波士顿科技公司和强生制药厂的股价产生了动荡。

Shares of Boston Scientific fell 3.3 percent, or 57 cents, to $16.70. The stock of Johnson & Johnson, whose overall business is less dependent on stents, fell 46 cents, to $63.46.

波士顿科技公司的股票下跌了3.3%(57美分),达到了每股16.70美元。与波士顿科技公司相比,强生制药厂的经营对血管支架业务的依赖性较小,其股价下降了46美分,降到每股63.46美元。

The declines came after a stream of reports about stent safety from a European medical meeting. Those included the disclosure yesterday that Boston Scientific had quietly told federal regulators this summer that new analysis of the company's accumulating safety data found that patients using its best-selling Taxus stent had a slightly greater but statistically clear risk of developing potentially deadly blood clots compared with older stent designs.

股票价格下跌是由于欧洲医学会议的一系列关于血管支架安全方面的报道引起的。这也包括了昨天披露波士顿科技公司AXUS支架存在风险的报导。报道说,波士顿科技公司曾经在今年夏天坦然地告诉联邦调节员,根据公司累积安全数据分析显示,与老的支架设计相比,患者使用该公司最畅销的TAXUS支架有稍大但确定的风险罹患潜在的致命血栓。

Among the earlier reports at the meeting was a Swiss study suggesting that in some patient groups the Cypher stent of Johnson & Johnson posed even higher long-term clotting risks than Taxus.

在会议早期的报告中有一个来自于瑞士的研究结果,它显示在一些患者群中,使用强生制药厂的CYPHER支架比使用Taxus支架有更大的长期血栓风险。

Stents are metal sleeves inserted in arteries to keep them propped open after medical procedures to clear blockages. Although some are used during heart bypass surgery, most coronary stents are inserted as a follow-up to angioplasty, a less invasive procedure in which the blockage is cleared from inside the artery by inflating a balloon. The balloon and stent are delivered to the heart area via a long catheter inserted into a blood vessel in the patient's thigh.

血管支架是置于动脉管内的金属套管,用于在清除血管阻塞医学治疗后维持血管畅通。虽然也有一些被用于心脏搭桥手术,但大多数心血管支架用于血管成形术的后续治疗器械,这样可以使通过给气球充气从动脉内部清除动脉阻塞的过程更不易扩散。气球和支架经导管通过患者大腿血管置入到心脏区域。

Stents were first used in the 1990's. The original designs were bare metal devices. Cypher, introduced in the United States in 2003, and Taxus, which was cleared for sale in 2004, are drug-coated devices. The coatings are meant to combat the tendency of arteries to form new blockages, a process called restenosis.

血管支架首先在20世纪90年代开始使用,最初完全是由金属制成。Cypher于2003年亮相美国市场,Taxus于2004年面市。两款器械外面都包裹着药物涂层。这些药物涂层用于防止再狭窄过程,即动脉血管产生新阻塞。

Although the drug-coated devices cost more than $2,000 on average, compared with $800 or so for bare metal devices, they rapidly supplanted the older designs in the United States and now account for 85 percent to 90 percent of the market.

尽管这种药物涂层血管支架平均价值超过2000美元,比800美元的纯金属器械贵得多,但是这种器械却在美国很快取代了老的器械,现在已经占有85%到90%的市场份额。

Analysts said that the stock market reaction reflected fears that growth in the stent market would slow and that more doctors would prescribe the less profitable bare metal products.

分析家认为,股市反应显示出投资者们担心支架市场的增长可能会放缓,更多的医生将会给患者使用利润更小的纯金属器械。

Word of Boston Scientific's report to regulators, whom it met with on Aug. 1, and the news that Food and Drug Administration officials then asked Johnson & Johnson for more data on its Cypher stent, was reported yesterday in The Wall Street Journal.

华尔街日报昨日(9月7日)报道说,有消息显示波士顿科技公司与调节员在8月1日见面并提供了报告,美国食品和药物管理局官员随后要求强生制药厂提供更多Cypher支架的信息

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