The AltaValve TMVR system. [Image courtesy of 4C Medical Technologies]4C Medical Technologies announced today that it commenced enrollment in its ATLAS pivotal trial evaluating its AltaValve system.

AltaValve TMVR系统。[图片由4C Medical Technologies提供]4C Medical Technologies今天宣布，它开始参加ATLAS pivotal试验，评估其AltaValve系统。

ATLAS (a transseptal left atrial system for the treatment of mitral regurgitation, or MR) evaluates AltaValve’s safety and efficacy. Participants in the study have moderate-to-severe or severe MR and are unsuitable for surgery or transcatheter edge-to-edge repair (TEER).

ATLAS（用于治疗二尖瓣关闭不全或MR的经中隔左房系统）评估了AltaValve的安全性和有效性。该研究的参与者患有中度至重度或重度MR，不适合手术或经导管边缘修复（TEER）。

The trial features two separate, non-randomized cohorts. One cohort includes patients with moderate/severe mitral annular calcification (MAC). The other — the primary cohort — includes patients with no or mild MAC. Dr. Yoshi Kaneko of Barnes-Jewish Hospital (St. Louis) and Dr. Paul Sorajja of Minneapolis Heart Institute serve as co-principal investigators.

该试验以两个独立的非随机队列为特征。一个队列包括中度/重度二尖瓣环钙化（MAC）患者。另一个是主要队列，包括无MAC或轻度MAC的患者。巴恩斯犹太医院（圣路易斯）的Yoshi Kaneko博士和明尼阿波利斯心脏研究所的Paul Sorajja博士担任联合首席研究员。

Dr. Ron Waksman of Medstar Washington Hospital Center (Washington, D.C.) serves as steering committee chair for ATLAS..

Medstar华盛顿医院中心（华盛顿特区）的Ron Waksman博士担任ATLAS的指导委员会主席。。

In Europe, Dr. Vlasis Ninios of Interbalkan Medical Center (Greece) and Dr. Lenard Conradi of University Hospital Cologne (Germany) share co-principal investigator responsibilities.

在欧洲，Interbalkan医学中心（希腊）的Vlasis Ninios博士和科隆大学医院（德国）的Lenard Conradi博士共同承担首席研究员的责任。

“We are excited to have successfully enrolled the first US patients in the ATLAS trial,” said Sorajja. “It is an intuitive and predictable procedure with a repositionable implant that is very much needed for the treatment of patients worldwide.”

Sorajja说：“我们很高兴在ATLAS试验中成功招募了首批美国患者。”。“这是一种直观且可预测的手术，具有可重新定位的植入物，对于全球患者的治疗非常必要。”

More about the 4C heart valve technology

关于4C心脏瓣膜技术的更多信息

Minneapolis-based 4C designed its transcatheter mitral valve replacement (TMVR) technology to address MR. MR can lead to heart failure or death if untreated. The company received FDA breakthrough device designation for the system earlier this year.

总部位于明尼阿波利斯的4C设计了经导管二尖瓣置换术（TMVR）技术，以解决MR如果不治疗可能导致心力衰竭或死亡的问题。今年早些时候，该公司获得了FDA对该系统的突破性设备指定。

Due to the complexity of the valve’s anatomy and comorbidities, limited medical therapies currently exist for MR. AltaValve could enter a market currently led by the Abbott MitraClip transcatheter mitral valve repair system.

由于瓣膜解剖结构的复杂性和合并症，AltaValve先生目前存在的有限药物治疗可能会进入目前由雅培MitraClip经导管二尖瓣修复系统主导的市场。

In a news release, Waksman called AltaValve the first atrial fixation TMVR device designed to minimize the challenges of sub-valvular TMVRs. Sorajja touted the system’s potential to “offer the broadest applicability for wide range of pathologies.”

在一份新闻稿中，Waksman称AltaValve是第一个心房固定TMVR装置，旨在最大程度地减少瓣膜下TMVR的挑战。索拉贾（Sorajja）吹捧该系统具有“为各种病理学提供最广泛适用性”的潜力

“It takes significant dedication and a lot of teamwork to take an innovative solution to treat MR from ideation to a global pivotal trial. We are very grateful for such strong support from key opinion leaders worldwide who are helping us carry our novel AltaValve System through pivotal trial with a goal of delivering safe and effective treatment solution for patients suffering from MR,” said Saravana Kumar, CEO and President at 4C Medical..

4C Medical首席执行官兼总裁萨拉瓦纳·库马尔（SaravanaKumar）表示：“从构思到全球关键试验，采取创新解决方案治疗MR需要付出巨大的奉献和大量的团队合作。我们非常感谢全球关键意见领袖的大力支持，他们正在帮助我们通过关键试验来实现新型AltaValve系统，旨在为MR患者提供安全有效的治疗方案。”。。