Conformal Medical

适形医疗

today announced on social media that the first U.S. site enrolled a patient in a trial of its next-gen heart implant.

今天在社交媒体上宣布，其下一代心脏植入物的试验中，第一个美国站点已招募了一名患者。

The company said on LinkedIn that Dr. Christopher R. Ellis and the Vanderbilt University Medical Center Cardiovascular team enrolled a patient in the CONFORM FDA investigational device exemption (IDE) trial. The trial evaluates the next-generation CLAAS AcuForm device.

该公司在LinkedIn上表示，Christopher R. Ellis博士和范德比尔特大学医学中心心血管团队已将一名患者纳入CONFORM FDA研究设备豁免（IDE）试验。该试验评估下一代CLAAS AcuForm设备。

Conformal Medical designed its CLAAS AcuForm left atrial appendage occlusion (LAAO) system to build upon the

Conformal Medical 设计了其 CLAAS AcuForm 左心耳封堵 (LAAO) 系统以建立在

novel CLAAS device

新型CLAAS设备

. It conforms and seals the LAA with its proprietary foam-based architecture. The implant aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram (TEE) so that physicians may perform the procedure without general anesthesia.

. 它利用其专有的泡沫结构来顺应并密封左心耳。该植入物旨在简化递送过程，并消除对经食管超声心动图 (TEE) 的需求，以便医生可以在不使用全身麻醉的情况下进行手术。

The company plans to enroll up to 1,600 patients in its CONFORM pivotal trial.

该公司计划在其CONFORM关键试验中招募多达1600名患者。

“Today marks a significant milestone in advancing LAAO procedures and sets the stage for the next phase of the CONFORM trial,” the company

“今天标志着LAAO手术程序的一个重要里程碑，并为CONFORM试验的下一阶段奠定了基础，”该公司表示。

wrote

写了

on LinkedIn. “We’re thrilled to bring this cutting-edge technology to more sites nationwide!”

在LinkedIn上写道：“我们很高兴将这项尖端技术推广到全国更多的地方！”

The LAA space remains an interesting one to monitor. Boston Scientific offers the

左心耳封堵器（LAA）领域仍然是一个值得关注的有趣领域。波士顿科学公司提供相关的解决方案。

Watchman system

监视系统

that currently mainly competes against offerings like Abbott’s Amplatzer Amulet. However, Medtronic

目前主要与雅培的Amplatzer Amulet等产品竞争。然而，美敦力

threw its hat in the ring with the launch of its Penditure LAA exclusion system

随着其Penditure LAA排除系统的推出，它也加入了竞争行列

in November 2023. That caused

2023年11月，这一事件导致

worry among AtriCure investors

AtriCure投资者的担忧

, as AtriCure develops its own LAAC device — the AtriClip.

，AtriCure正在开发自己的LAAC设备——AtriClip。

Meanwhile, Johnson & Johnson made its own LAA play late in 2023 with the

同时，强生公司在2023年底也进行了自己的LAA操作。

$400 million acquisition of Laminar

4亿美元收购Laminar

. Laminar’s LAA device aims to completely eliminate the appendage to treat AFib.

Laminar的LAA装置旨在完全消除心耳以治疗房颤。