Enginprime Medical Inc Launches First Human Study of OpusOne™ pVAD
Enginprime Medical Inc, an emerging leader in the field of percutaneous ventricular assist device (pVAD) technologies, proudly announces a significant milestone. This innovative company, which operates under the umbrella of Voyagers Capital, has initiated its first-in-human clinical study of its leading device, OpusOne™, at The Second Affiliated Hospital, School of Medicine, Zhejiang University.
Advancements in Cardiac Support Technology
The OpusOne™ device is designed to support cardiac output through a percutaneously implanted pump, thoroughly addressing heart failure symptoms and serving as a bridge to transplantation or recovery. The device's engineering augments cardiac output, enhances organ perfusion, and stabilizes hemodynamics, especially during complex higher-risk procedures.
With more than 60,000 pVAD procedures carried out globally each year, it is important to note that no pVAD product has yet received approval for use in China. This gap signifies a pronounced unmet medical need that OpusOne™ seeks to fill.
Innovative Features of OpusOne™
OpusOne™ boasts an ultra-low profile of merely 8F, external motor placement for increased durability, and a state-of-the-art foldable, self-expanding impeller. This remarkable device is capable of delivering an average flow of 4–5 liters per minute, with peak flows exceeding 7 liters per minute. Its compact design also incorporates invasive blood pressure monitoring and a patented perfusion purification system to detect migration alerts and prevent harmful wear particles from entering the patient’s body.
The combination of high durability and reliability simplifies clinical procedures, enhances patient access, and positions OpusOne™ as a strong competitor in the pVAD market, alongside other notable devices like Abiomed's Impella and Magenta's Elevate systems.
Insights from Clinical Leaders
According to Jian’an Wang, MD, PhD, the Director of the Cardiac Center at SAHZU and the lead investigator for the study, "Enginprime's OpusOne™ shows significant promise in providing temporary ventricular support, especially for high-risk patients. It is uniquely designed to meet the clinical needs of patients requiring enhanced hemodynamic stability." He emphasized the device's low-profile design, which optimizes access and safety during procedures.
Co-investigator Jun Jiang, MD, PhD, Executive Associate Director of the Department of Cardiology at SAHZU, expressed enthusiasm regarding the initial testing of OpusOne™. Jiang noted, "The first procedure demonstrated a remarkable alleviation of the patient’s chest tightness, indicating the device’s strong potential in circulatory support and widening eligibility for patients in need of this technology."
A Commitment to Innovative Healthcare Solutions
The CEO of Enginprime underscored the company’s mission: "The development of OpusOne™ is a testament to our commitment to providing exceptional, cost-effective next-generation circulatory support solutions to patients. We are eager to push this innovative device through further clinical validation processes to demonstrate its efficacy."
About Enginprime Medical Inc.
Founded in 2023, Enginprime is incubated under the majority ownership of Voyagers Capital, bringing together cross-disciplinary engineering expertise, systems integration, and advanced manufacturing methods. OpusOne™, as the flagship device of the company, exemplifies Voyagers Capital's dedication to supporting trailblazing healthcare innovations.
About Voyagers Capital
Voyagers Capital is distinguished as a premier healthcare venture capital firm dedicated to investing in revolutionary biotech and medtech innovations. By drawing on our extensive expertise and networks, we collaborate with entrepreneurs who have the vision to deliver transformative healthcare solutions to the global market.
It is essential to note that OpusOne™ is an investigational device and has not yet been approved for commercial use.
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Frequently Asked Questions
What is the purpose of the OpusOne™ device?
The OpusOne™ device supports cardiac output, alleviating heart failure symptoms, and facilitating organ function during specific procedures.
Where is the first clinical study of OpusOne™ taking place?
The inaugural study is being conducted at The Second Affiliated Hospital, School of Medicine, Zhejiang University.
What are the innovative features of OpusOne™?
OpusOne™ features an ultra-low profile, self-expanding impeller, and a system that monitors invasive blood pressure while ensuring patient safety.
How does OpusOne™ compare to other devices?
OpusOne™ is positioned as a competitive option against existing systems like Abiomed's Impella, focusing on high performance and reliability.
Is OpusOne™ approved for commercial use?
No, OpusOne™ is currently an investigational device and has not received approval for commercial distribution.
