AtriCure wins expanded indications for AtriClip LAA

FDA 510K批准扩展AtriCure公司AtriClip左心耳设备适应症

2019-08-28 13:00:57 mass


AtriCure  said today that it won expanded 510 clearances from the FDA for its AtriClip left atrial appendage device. The new indications cover a change from occlusion of the LAA to exclusion and adding electrical isolation as a claim, Mason, Ohio-based AtriCure said. AtriClip excludes the LAA and causes its tissue to die from loss of blood supply, eliminating it as an electrical activity source via ischemic necrosis, the company said. “We continue to demonstrate our leadership in the LAA management space by expanding our labeling claims for AtriClip devices,” president & CEO Michael Carrel said in prepared remarks. “The ability to simultaneously exclude and electrically isolate the LAA using an AtriClip device builds on our growing portfolio of devices. Over the past several years, we have incrementally expanded our labeling to reflect the growing clinical use for AtriClip devices. We anticipate additional labeling expansion in the future as the number of users of AtriClip devices grow.” “Historically, the surgical amputation of the left atrial appendage in a cut-and-sew fashion was considered to be the gold standard for LAA management,” added Dr. Patrick Whalen of Wake Forest Baptist Health. “The AtriClip device mimics the gold standard by eliminating the LAA by epicardial, mechanical closure. The subsequent ischemic necrosis process ceases all electrical activity in the LAA perioperatively and the appendage is ultimately resorbed.” “Our research has defined a clear benefit of the electrical isolation of the LAA,” Dr. Dhanunjaya Lakkireddy, of the Kansas City Heart Rhythm Institute, said in a press release. “The AtriClip device excludes the left atrial appendage in a manner that could result in its electrical isolation.” Earlier this month AtriCure closed the $300 million buyout of SentreHeart and its Lariat left atrial appendage closure device. ATRC shares were up 0.9% to $27.00 apiece today in late-morning trading.
AtriCure 今天说,它赢得了 FDA 对其 AtriClip 左心房附属器的510个批准。 俄亥俄州的 AtriCure 公司的 Mason 说,新的适应症包括从左心耳阻塞到排除和增加电隔离。该公司表示, AtriClip 不包括 LAA ,导致其组织因缺血而死亡,通过缺血性坏死将其作为电活动来源。 “我们通过扩大 AtriClip 设备的标签声明,继续展示我们在 LAA 管理领域的领导地位,”总裁兼首席执行官迈克尔•卡尔( Michael Carrel )在准备好的讲话中表示。“使用 AtriClip 设备同时排除和隔离 LAA 的能力建立在我们不断增长的设备组合之上。在过去的几年里,我们逐步扩大我们的标签,以反映日益增长的临床使用的 AtriClip 设备。随着 AtriClip 设备用户数量的增长,我们预计未来还会有更多的标签扩展。” 维克森林浸信会健康公司的帕特里克·沃尔伦博士补充说:“从历史上看,手术切除左房附属物的手术被认为是 LAA 治疗的黄金标准。”“ AtriClip 设备通过震心性机械闭合消除 LAA 来模拟黄金标准。随后的缺血性坏死过程在手术期间停止了 LAA 的所有电活动,而附属物最终被吸收。” “我们的研究明确了 LAA 电气隔离的一个明显好处,”堪萨斯城心脏 Rhythm 研究所的 DannjiayLakkerirddy 博士在一份新闻稿中说。“ AtriClip 设备以一种可能导致其电气隔离的方式排除了左心房附件。” 本月早些时候, AtriCure 完成了对 SentreHeart 和它的 Lariat 左房附属器的3亿美元收购。 ATRC 股价在昨日早盘交易中上涨0.9%,至每股27.00美元。