Supira Medical announced today that it began patient enrollment in a U.S. early feasibility trial of its percutaneous ventricular assist device (pVAD).

苏皮拉医疗公司今天宣布，该公司开始在其经皮心室辅助装置（pVAD）的美国早期可行性试验中招募患者。

The Shifamed portfolio company plans to evaluate the pVAD in patients undergoing high-risk percutaneous coronary intervention (HRPCI). Los Gatos, California-based Supira’s study looks at the safety and feasibility of the low-profile, high-flow device.

Shifamed投资组合公司计划评估接受高危经皮冠状动脉介入治疗（HRPCI）的患者的pVAD。位于加利福尼亚州洛斯加托斯的苏皮拉的研究着眼于这种薄型高流量装置的安全性和可行性。

Dr. David Kandzari, chief of the Piedmont Heart Institute and national principal investigator, performed the first case.

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“I am pleased to share that Supira’s U.S. EFS began with its first successful enrollment, supporting the enthusiasm among investigators to bring this program to the U.S.,” Kandzari said. “The Supira pump delivers impressive flow rates through a remarkably small profile, with a console that supports simplified workflows.

坎扎里说：“我很高兴与大家分享，苏皮拉的美国EFS从首次成功注册开始，支持了调查人员将该项目带到美国的热情。”。“Supira泵通过非常小的外形提供令人印象深刻的流量，控制台支持简化的工作流程。

This unique combination promises to address limitations of presently available options while enhancing cath lab efficiency.”.

这种独特的组合有望解决目前可用选项的局限性，同时提高cath实验室的效率。”。

pVADs support cardiovascular function during HRPCI. They’re particularly important in patients with complex coronary anatomy, compromised hemodynamics, and multiple comorbidities. Additional uses include in cardiogenic shock, a high-mortality condition.

PVAD在HRPCI期间支持心血管功能。对于冠状动脉解剖结构复杂，血流动力学受损和多种合并症的患者，它们尤为重要。其他用途包括心源性休克，这是一种高死亡率的疾病。

Supira announced the first human use of its pVAD just over two years ago.

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“We believe the Supira System is a transformative innovation and look forward to expanding the significant body of evidence from our 70-patient South America experience. With these U.S. cases, we are one step closer to our goal of reshaping outcomes for patients while delivering value for physicians and the healthcare system,” commented Dr. Nitin Salunke, President and CEO of Supira.

“我们相信Supira系统是一项变革性创新，并期待着从我们70名患者的南美经验中扩大大量证据。有了这些美国案例，我们离重塑患者结局的目标又近了一步，同时为医生和医疗保健系统带来了价值，”Supira总裁兼首席执行官尼廷·萨伦克博士评论道。

“I would like to thank our clinical advisors for their strong, continued support and our team for their tireless efforts to achieve this historic milestone.”.

“我要感谢我们的临床顾问的大力支持，感谢我们的团队为实现这一历史性里程碑所做的不懈努力。”。