BURLINGTON, Mass., May 1, 2024 /PRNewswire/ -- BrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, today announced it has received FDA Investigational Device Exemption (IDE) approval with conditions to commence enrollment in its landmark INNOVATE trial.

马萨诸塞州伯灵顿，2024年5月1日/PRNewswire/-BrioHealth Solutions，Inc.，一家专注于开发创新型晚期心力衰竭解决方案的医疗技术公司，今天宣布已获得FDA研究设备豁免（IDE）批准，并有条件开始参加其具有里程碑意义的创新试验。

The study will assess the effectiveness and safety of its novel BrioVAD™ System, a magnetically levitated ventricular assist device, in treating refractory left ventricular heart failure. With the notice, BrioHealth Solutions has initiated clinical site start-up activities in the US..

该研究将评估其新型BrioVAD™系统（一种磁悬浮心室辅助装置）治疗难治性左心室心力衰竭的有效性和安全性。根据通知，BrioHealth Solutions已在美国启动了临床现场启动活动。。

The BrioVAD Left Ventricular Assist System is designed to aid patients suffering from advanced heart failure, offering both temporary and long-term support solutions. The BrioVAD System consists of a novel hemocompatible blood pump with a fully magnetically levitated rotor and two small, lightweight, patient-worn components.

BrioVAD左心室辅助系统旨在帮助患有晚期心力衰竭的患者，提供临时和长期支持解决方案。BrioVAD系统由一种新型血液相容性血泵组成，该血泵具有完全磁悬浮的转子和两个小而轻的患者佩戴部件。

This advanced technology is designed to help patients overcome the limitations of heart failure and enhance quality of life. The BrioVAD system will be evaluated in the INNOVATE trial randomized relative to technology previously approved by the FDA..

这项先进的技术旨在帮助患者克服心力衰竭的局限性，提高生活质量。BrioVAD系统将在INNOVATE试验中进行评估，该试验将根据FDA先前批准的技术进行随机分组。。

'Achieving this stage of FDA approval for the INNOVATE trial marks an important step in providing more options to clinicians and patients seeking advanced heart failure therapies,' said Francis D. Pagani, M.D., Ph.D., the Otto Gago MD Endowed Professor in Cardiac Surgery at the University of Michigan and the study's National Principal Investigator.

密歇根大学（University of Michigan）奥托·加戈医学博士（Otto Gago MD）心脏外科教授、该研究的国家首席研究员弗朗西斯·帕加尼（Francis D.Pagani）医学博士（Ph.D.）说，获得美国食品和药物管理局（FDA）对INNOVATE试验的这一阶段批准，标志着为寻求先进心力衰竭治疗的临床医生和患者提供更多选择的重要一步。

'The clinical evaluation of the BrioVAD System is a significant leap forward for the entire field of heart failure. Countless patients go untreated each year and continue to suffer with this seriously debilitating condition,' Dr. Pagani emphasized..

“BrioVAD系统的临床评估是整个心力衰竭领域的重大飞跃。帕加尼博士强调说，每年都有无数患者得不到治疗，并继续遭受这种严重的衰弱状况。。

'We are excited to have achieved this crucial milestone. Our goal is to deliver patient-centered solutions for advanced heart failure patients and their families,' remarked Chen Chen, Ph.D. CEO of BrioHealth Solutions. 'The innovative BrioVAD System, with its compact pump designed for hemocompatibility along with small, lightweight peripherals, has been engineered to restore patients back to active lifestyles.'.

“我们对实现这一关键里程碑感到兴奋。BrioHealth solutions首席执行官陈晨博士表示，我们的目标是为晚期心力衰竭患者及其家属提供以患者为中心的解决方案创新的BrioVAD系统，其紧凑的泵设计用于血液相容性以及小型轻便的外围设备，已被设计用于使患者恢复活跃的生活方式。”。

About BrioHealth Solutions:BrioHealth Solutions is developing the BrioVAD™ System, a left ventricular assist system representing a significant advanced heart failure innovation. The company's founding mission is a commitment to restoring, extending and enhancing the lives of patients globally by collaborating with healthcare providers to push the boundaries of what's possible and deliver the best medical technologies and solutions.

关于BrioHealth Solutions：BrioHealth Solutions正在开发BrioVAD™系统，这是一种左心室辅助系统，代表了一项重大的先进心力衰竭创新。该公司的创立使命是致力于通过与医疗保健提供者合作，在全球范围内恢复、延长和改善患者的生活，以突破可能的界限，并提供最佳的医疗技术和解决方案。

The BrioVAD System is an investigational device limited by federal law for investigational use only..

BrioVAD系统是一种受联邦法律限制的研究设备，仅用于研究用途。。

For more information on BrioHealth Solutions, please visit the company website at www.briohealthsolutions.com and follow us on LinkedIn @BrioHealthSolutions and Twitter/X @BrioVAD.

有关BrioHealth解决方案的更多信息，请访问公司网站www.briohealthsolutions.com，并在LinkedIn@briohealthsolutions和Twitter/X@BrioVAD上关注我们。

SOURCE BrioHealth Solutions, Inc.

SOURCE BrioHealth Solutions，Inc。