US EditionEnginprime Medical Inc Announces First-in-Human Study of Its Leading OpusOne™ pVAD
OpusOne pVAD begins clinical trials to evaluate safety and performance, addressing China’s unmet need with over 60,000 global pVAD procedures annually, none yet approved locally.
- On Dec. 16, 2025, Enginprime Medical Inc. announced OpusOne pVAD entered its first-in-human clinical study at The Second Affiliated Hospital, School of Medicine, Zhejiang University, marking its first clinical safety and performance evaluation.
- With no pVAD product approved in China, Enginprime, founded in 2023 and incubated by Voyagers Capital, developed OpusOne to address this clinical and commercial gap.
- Enginprime's OpusOne features a foldable self-expanding impeller delivering average 4–5 L/min and peak over 7 L/min, with external motor placement and integrated invasive blood pressure monitoring plus patented perfusion purification system.
- OpusOne could shift competitive dynamics by supporting cardiac output, reducing left-ventricle load, and positioning as a cost-effective alternative to Abiomed's Impella, Magenta's Elevate, and Supira's pVAD systems.
- Advancing OpusOne through additional trials, Enginprime said co-investigator Jun Jiang, MD, PhD noted improved safety and symptom relief, while Enginprime and Voyagers Capital plan rapid further clinical validations.
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Enginprime Medical Inc Announces First-in-Human Study of Its Leading OpusOne™ pVAD
HANGZHOU, China, Dec. 15, 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…
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…
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