【奥译言】全球首个治疗早产儿和新生儿先天心脏畸形的设备获美国FDA批准上市

2019-02-19 11:41 阅读数：3811 标签：

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美国雅培公司（Abbott）的Amplatzer Piccolo封堵器成功获得美国FDA批准上市。

雅培公司于1月14日表示，该封堵器还没有一粒豌豆大，是全球首个获得FDA批准的用于治疗早产儿和新生儿（最小体重仅为两磅）的动脉导管未闭（PDA）医疗设备。

动脉导管未闭是一种在早产儿中常见的先天性心脏畸形，是指胎儿出生后连接肺动脉与主动脉之间的动脉导管继续存在，这道未闭合的开口随时可能危及新生儿的生命。在美国，每年大约有6万名早产儿出生时体重很轻，其中近1.2万名早产儿有很严重的动脉导管未闭，会引发一系列的症状，需要急救治疗才能存活。

Amplatzer Piccolo封堵器是一种自膨式丝网装置，在婴儿出生后动脉导管无法闭合的情况下，可以通过腿部切口进行手术植入。研究表明，低出生体重早产儿一旦患有动脉导管未闭，会导致极高的死亡率。

FDA对该产品予以批准是基于其在一项名为ADO II AS的关键性临床试验的表现。该试验在全美国8个中心展开，共招募了50名出生超过三天的动脉导管未闭新生儿患者。雅培发言人Mary Kokkinen告诉Focus：“FDA通过上市前审批（PMA）途径对Amplatzer Piccolo设备进行了评估”。

雅培公司表示，该设备是基于其 Amplatzer闭合器系列疗法二十多年的临床成功经验开发的。该产品系列原先属于美国另一家医疗器械制造商圣犹达（St. Jude Medical），现已被雅培公司收购。

英文原文

Abbott Snags FDA Approval for Neonatal Heart Device

Abbott obtained US Food and Drug Administration (FDA) approval for its pea-sized Amplatzer Piccolo Occluder.

This is the first medical device in the world to receive FDA approval for the treatment of patent ductus arteriosus (PDA) in premature babies and newborns weighing as little as two pounds, Abbott said Monday.

PDA is a potentially life-threatening opening between two blood vessels leading from the heart. Approximately 60,000 premature babies in the US are born each year with a very low birth weight and nearly 12,000 of these have a PDA that is large and causes symptoms that will require urgent treatment for the baby to survive

The self-expanding wire mesh device can be surgically implanted through an incision in the leg when this channel fails to close after birth. PDA in premature infants with low birth weight has been associated with “extremely high mortality rates,” research shows.

The trial conducted to support the FDA approval involved 50 PDA patients who were older than three days across eight US centers. The agency evaluated the device through the premarket approval pathway, Abbott spokesperson Mary Kokkinen told Focus.

The device builds on the years of the Amplatzer family’s clinical success, Abbott said. The product line belonged to St. Jude Medical prior to Abbott’s acquisition amid lawsuits brought on over risk to health.

内容来自：RAPS

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