Enginprime Medical begins first human study of OpusOne heart pump

HANGZHOU, China, Dec. 16, 2025 /PRNewswire/ -- Enginprime Medical Inc ("Enginprime"), an emerging leader in percutaneous ventricular assist device (pVAD) technologies and a Voyagers Capital portfolio company, today announced that its industry leading pVAD, OpusOne™, has entered its first-in-human clinical study at The Second Affiliated Hospital, School of Medicine, Zhejiang University ("SAHZU"). This milestone marks the first clinical evaluation of the device's safety and performance in patients.

PVAD supports the cardiac output via a percutaneously implanted pump, reduces the load of left ventricle, relieves heart failure symptoms, and bridges to transplantation or recovery. It also delivers temporary hemodynamic support during Complex Higher-risk Indicated Patients Percutaneous Coronary Intervention (CHIP PCI) procedures by augmenting cardiac output, preserving organ perfusion, and stabilizing hemodynamics for safe intervention. While over 60,000 pVAD procedures are performed globally each year, no pVAD product has been approved in China yet, underscoring the significant unmet medical need.

OpusOne™ features an ultra-low profile down to 8F, external durable motor placement, and an all-new design of foldable, self-expanding impeller, capable of delivering 4–5 L/min of average flow with peak flows exceeding 7 L/min. Notably, this ultra-compact device integrates invasive blood pressure monitoring and patented perfusion purification system, enabling migration detection alerts while preventing wear particles from entering the patient's body. With high durability, enhanced reliability, OpusOne™ simplifies clinical procedures, improves patient accessibility, and emerges as a highly competitive pVAD - rivaling Abiomed's Impella, Magenta's Elevate, and Supira's pVAD systems.

"Enginprime's OpusOneTM exemplified a promising approach to temporary ventricular support—especially for high-risk patients who can benefit from enhanced hemodynamic stability. Co-developed by the interventional cardiologists and Enginprime, this promising solution is tailored to address unmet clinical needs." said the study's lead investigator Jian'an Wang, MD,PhD, Director of the Cardiac Center at SAHZU. "I am impressed by its ability to achieve high flow with such a low-profile design. OpusOneTM's optimization of access and positioning options increases procedural safety."

Co-investigator of the study, Jun Jiang, MD, PhD, Executive Associate Director of the Department of Cardiology at SAHZU added, "We are pleased to perform the first procedure with OpusOneTM, seeing the patient's chest tightness was significantly alleviated. Its robust initial performance marks a meaningful advancement in circulatory support and great potential for expanding patient eligibility."

"The development of OpusOneTM 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," said the CEO of Enginprime. "We look forward to advancing this innovative device rapidly through further clinical validations."