4C Medical Technologies was awarded Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its AltaValve transcatheter mitral valve replacement (TMVR) device.

4C Medical Technologies因其AltaValve经导管二尖瓣置换术（TMVR）设备获得美国食品和药物管理局（FDA）的突破性设备称号。

AltaValve was specifically granted breakthrough status for two indications: Treating moderate-to-severe mitral regurgitation (MR) and moderate-to-severe- or severe MR with moderate/severe mitral annular calcification (MAC).

AltaValve在两个适应症方面获得了突破性地位：治疗中度至重度二尖瓣关闭不全（MR）和中度至重度或重度MR伴中度/重度二尖瓣环钙化（MAC）。

4C Medical’s TMVR differentiates from other MR replacement devices with an atrial-only fixation. It preserves the native mitral valve and left ventricle, minimizing challenges associated with traditional TMVR replacement technologies. These rely on placement and fixation in the native mitral annulus and left ventricle..

4C Medical的TMVR区别于其他仅具有心房固定的MR替代设备。它保留了原生的二尖瓣和左心室，最大程度地减少了与传统TMVR替代技术相关的挑战。这些依赖于天然二尖瓣环和左心室的放置和固定。。

The atrial-only fixation of the technology is designed to minimize the complexities and variabilities associated with anchoring to the mitral annulus,' said Dr. Jeff Chambers, founder and chief medical officer of 4C Medical. 'This differentiated approach preserves critical cardiac structures, reducing the risk of left ventricular outflow tract obstruction or damage to the left ventricle.'.

4C medical创始人兼首席医疗官杰夫·钱伯斯（JeffChambers）博士说，该技术的仅心房固定旨在最大限度地减少与锚定二尖瓣环相关的复杂性和变异性这种有区别的方法保留了关键的心脏结构，降低了左心室流出道阻塞或左心室损伤的风险。”。

The company achieved favorable results for patients treated in its early feasibility study. AltaValve was shown to be a promising option with high procedure success and MR elimination in most patients at 30 days, according to Vlasis Ninios, M.D., interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece) and an investigator in the study..

该公司在早期可行性研究中为接受治疗的患者取得了良好的效果。据Interbalkan医学中心（希腊塞萨洛尼基）介入心脏病专家Vlasis Ninios医学博士和该研究的一名研究人员称，AltaValve被证明是一种很有前途的选择，在30天内大多数患者的手术成功率和MR消除率都很高。。

'The dual Breakthrough Designation of the AltaValve System is an important milestone for the 4C Medical clinical program, and we are excited to assess both indications in the upcoming the AltaValve Pivotal trial,' said 4C Medical CEO Saravana Kumar. 'This advancement enables us the opportunity to bring this needed technology to our patients even sooner.' .

4C医疗首席执行官萨拉瓦纳·库马尔（SaravanaKumar）说：“AltaValve系统的双重突破性设计是4C医疗临床计划的一个重要里程碑，我们很高兴在即将到来的AltaValve关键试验中评估这两种适应症。”这一进步使我们有机会更快地将这种所需的技术带给患者。”。