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Requiem for a Scaffold
Annals of Internal Medicine ( IF 39.2 ) Pub Date : 2017-10-17 , DOI: 10.7326/m17-2522
Sanket S. Dhruva 1 , Jeptha P. Curtis 1
Affiliation  

On 8 September 2017, the medical device manufacturer Abbott announced that it would halt the sale of its Absorb GT1 bioresorbable vascular scaffold (BVS), citing low sales and unsustainable margins (1). At the time of the announcement, Absorb accounted for less than 1% of the overall market for coronary stents, and the company's move came on the heels of a series of setbacks for the BVS program. In March 2017, Abbott, working with European authorities, imposed restrictions on BVS use outside clinical trials and registries. In that same month, the U.S. Food and Drug Administration (FDA) issued a letter to health care providers about potential safety concerns (2).


中文翻译:

脚手架的安魂曲

2017年9月8日,医疗器械制造商雅培宣布以低销售额和不可持续的利润为理由停止其Absorb GT1生物可吸收血管支架(BVS)的销售。在发布之时,Absorb占冠状动脉支架整体市场的份额不到1%,该公司的举动是在BVS计划遭受一系列挫折之后​​。2017年3月,雅培与欧洲当局合作,在临床试验和注册机构之外对BVS的使用施加了限制。同月,美国食品和药物管理局(FDA)就潜在的安全隐患向医疗保健提供者发出了一封信(2)。
更新日期:2017-10-17
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