Enginprime’s OpusOne pVAD Evaluated in FIH Study

December 24, 2025—Enginprime Medical Inc., a developer of percutaneous ventricular assist device (pVAD) technologies and a Voyagers Capital portfolio company, announced that its has entered its first-in-human (FIH) clinical study of the safety and performance of its OpusOne pVAD. OpusOne is an investigational device that is not yet approved for commercial use.

According to the company, the ultracompact OpusOne is designed to integrate invasive blood pressure monitoring and perfusion purification system, enabling migration detection alerts while preventing wear particles from entering the patient’s body. The device features an ultralow profile down to 8 F, external durable motor placement, and a foldable, self-expanding impeller, capable of delivering 4-5 L/min of average flow with peak flows exceeding 7 L/min, stated Enginprime.

Enrollment in the FIH study commenced at The Second Affiliated Hospital, School of Medicine, Zhejiang University (SAHZU) in Hangzhou, China. The study’s lead investigator is Jian’an Wang, MD, Director of the Cardiac Center at SAHZU.

“Enginprime’s OpusOne exemplified a promising approach to temporary ventricular support—especially for high-risk patients who can benefit from enhanced hemodynamic stability,” commented Dr. Wang in the company’s press release. “Codeveloped by the interventional cardiologists and Enginprime, this promising solution is tailored to address unmet clinical needs. I am impressed by its ability to achieve high flow with such a low-profile design. OpusOne’s optimization of access and positioning options increases procedural safety.”

Study investigator Jun Jiang, MD, Executive Associate Director of the Department of Cardiology at SAHZU, added, “We are pleased to perform the first procedure with OpusOne, seeing that 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.”