#China #Hangzhou #pVAD #Enginprime #OpusOne

Enginprime Medical Inc. Launches First-in-Human Clinical Study for OpusOne™ pVAD

In a monumental advancement for heart failure treatment, Enginprime Medical Inc., an emerging leader in percutaneous ventricular assist device (pVAD) technologies, has announced that its innovative device, OpusOne™, has commenced its first-in-human clinical trial. This significant milestone was reached at The Second Affiliated Hospital, School of Medicine, Zhejiang University (SAHZU), as Enginprime’s team embarks on assessing the safety and efficacy of this state-of-the-art device in patients.

Understanding the OpusOne™ pVAD

The OpusOne™ pVAD is engineered to enhance cardiac output by utilizing a percutaneously implanted pump. Its primary function is to ease the workload on the left ventricle, thus alleviating symptoms associated with heart failure while providing crucial support that could be pivotal for patients awaiting heart transplants or those who require recovery. Moreover, during Complex Higher-risk Indicated Patients Percutaneous Coronary Intervention (CHIP PCI) procedures, the device plays a vital role by enhancing cardiac output, ensuring adequate organ perfusion, and stabilizing hemodynamics, thereby ensuring safer medical interventions.

With over 60,000 pVAD procedures conducted worldwide each year, the absence of an approved pVAD device in China emphasizes the urgent need for effective medical solutions in this domain. The OpusOne™ features an ultra-low profile design, as compact as 8F, with a durable external motor and a revolutionary foldable, self-expanding impeller capable of achieving flow rates of 4–5 L/min, with peak rates exceeding 7 L/min. This groundbreaking device introduces integrated invasive blood pressure monitoring and a unique perfusion purification system, which ensures alerts for migration detection and prevents any harmful particles from entering the patient’s bloodstream.

Groundbreaking Clinical Insights

The lead investigator for this clinical trial, Dr. Jian’an Wang, MD, PhD, who also serves as the Director of the Cardiac Center at SAHZU, expressed a strong belief in the potential of OpusOne™, saying, “Enginprime's OpusOne™ exemplified a promising approach to temporary ventricular support—especially for high-risk patients who can benefit from enhanced hemodynamic stability.” He highlighted the device's capability of delivering high flow rates despite its low-profile design, which ultimately enhances procedural safety through optimized access and positioning.

Co-investigator Dr. Jun Jiang, MD, PhD, the Executive Associate Director of the Department of Cardiology at SAHZU, shared his enthusiasm about the inaugural procedure with the OpusOne™. He reported a significant alleviation of the patient's chest tightness, crediting the device’s robust initial performance as a substantial advancement in circulatory support.

The CEO of Enginprime remarked, “The development of OpusOne™ reflects our mission to bring globally competitive, exceptional performance, and high reliability, cost-effective next-generation circulatory support products to patients who need them most.” His statement underscores the commitment to expediting clinical validation processes to deliver this revolutionary device to the market.

Future of Cardiovascular Support

Enginprime was founded in 2023, backed by Voyagers Capital, a venture capital firm dedicated to supporting transformative healthcare innovations. The company is enthusiastic about translating its research and development efforts into practical applications that address critical medical needs. The OpusOne™ pVAD not only promises to expand the eligibility of patients requiring cardiac assistance but also positions itself as a fierce competitor against existing solutions such as Abiomed's Impella, Magenta's Elevate, and Supira's pVAD systems.

This first-in-human trial sets the stage for a new era in pVAD technology, particularly in markets that have long awaited innovative solutions to tackle heart failure effectively. A successful trial could pave the way for widespread deployment, significantly improving the lives of patients suffering from severe heart conditions.

With its initial procedures now underway, Enginprime looks forward to gathering crucial data that could pave the way for the future of cardiac support devices across the globe.