Home NyokAssist® 9Fr Percutaneous Ventricular Assist Device Shows Promising Interim Safety Profile in High-Risk PCI: Results from a Multicenter RCT Presented at ISHLT 2025

NyokAssist® 9Fr Percutaneous Ventricular Assist Device Shows Promising Interim Safety Profile in High-Risk PCI: Results from a Multicenter RCT Presented at ISHLT 2025

May 10, 2025 20:39 CST Updated 20:39
magAssist

Developer of Extracorporeal Artificial Heart Devices

Boston, MA—April 27-30, 2025: The International Society for Heart and Lung Transplantation (ISHLT) Annual Meeting and Scientific Conference was held in Boston, Massachusetts. Experts from around the world in the fields of heart and lung failure, mechanical circulatory support (MCS), and transplantation gathered to share the latest advancements in research, technology, and clinical practice.

During the scientific conference, magAssistDr. Rui Wang from Academician Junbo Ge's TeamShared NyokAssist®Preliminary Results of a Prospective, Multicenter, Randomized Controlled Clinical Trial of a Transcatheter Ventricular Assist Device. The device isThe team of Academician Ge Junbo from Zhongshan Hospital, Shanghai, and magAssist (Suzhou) Co., Ltd. ("magAssist" for short)A new generation of interventional pump that responds to the call of the country and achieves integrated innovation through medical-engineering convergence.

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Test Background

This study is a prospective, multicenter, randomized controlled trial planning to enroll over 200 patients with left ventricular ejection fraction (EF) ≤40% or those scheduled for high-risk PCI (HR-PCI), including interventions on unprotected left main coronary arteries, the last remaining open coronary artery, or triple-vessel disease. Participants will be randomized in a 1:1 ratio to receive the NyokAssist.®and intra-aortic balloon pump (IABP), aimed to evaluate NyokAssist®Safety and Efficacy of Cardiovascular Hemodynamic Support in HR-PCI Patients.

Research Results

Preliminary research results show,NyokAssist®There were no significant differences between the two groups in terms of major adverse cardiovascular and cerebrovascular events (MACCE), mortality, target vessel revascularization, neurological complications (stroke/TIA), myocardial infarction (MI), renal complications, major vascular complications, and the incidence of hypotension during the support period at the time of hospitalization, 30 days post-operation, and 90 days post-operation. This suggests that NyokAssist®Its application in high-risk PCI patients is safe.

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Conclusion

Dr. Wang Rui pointed out, NyokAssist®NyokAssist is a foldable, externally driven micro axial flow pump designed for safe insertion through a 9Fr arterial access, providing a flow rate of up to 5L/min. Early study results show a low complication rate, with encouraging outcomes. However, further research and analysis of more patients are needed to gain a deeper understanding of NyokAssist.®Safety and Efficacy of IABP in High-Risk PCI.

About ISHLT


The International Society for Heart and Lung Transplantation (ISHLT) is a multidisciplinary organization dedicated to advancing research, education, and innovation in the treatment of patients with advanced heart and lung diseases. Since its founding in 1981, ISHLT has been the leading platform for cardiologists, cardiac surgeons, pulmonologists, transplant specialists, and researchers to share groundbreaking science, foster collaboration, and improve patient outcomes worldwide.



Further Reading

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Extracorporeal Left Heart Assist Replaces ECMO+IABP Combination: Zhujiang Hospital's Cardiothoracic Surgery Department Pioneers New Practices in Heart Failure Treatment
First Case in Guangdong Province After Market Approval! Prof. Xie Shaobo's Team from Guangzhou Medical University First Affiliated Hospital Uses a Domestically Produced Extracorporeal Magnetic Levitation Artificial Heart to Stabilize Acute Heart Failure Patient Until Heart Transplant
Huai'an First Hospital Successfully Performs the First High-Risk Surgery with Extracorporeal Ventricular Assist in a Jiangsu Prefecture-Level Public Hospital
A Turning Point Creates New Opportunities: Xinjiang Autonomous Region People's Hospital Uses magAssist's Minimally Invasive Extracorporeal Ventricular Assist Device MoyoAssist® to Successfully Bridge to Long-term Left Ventricular Assist
Kunhua Hospital Applies magAssist's Chinese-produced MoyoAssist® Magnetic Levitation Extra VAD® to Assist in Revascularization Surgery for High-risk PCI Patients
Xi'an First Hospital Completes Minimally Invasive Extra VAD®-Assisted One-Stop TAVR-PCI for Elderly Complex Patients

Asian Heart Valve China Forum: Focus on "Safe and Effective" and "Cost-Effective" Extracorporeal Ventricular Assist

ISMCS 2024 | magAssist Showcases World's Smallest pVAD Clinical Progress and Other Latest Technological Achievements, Competing Alongside International Giants!
Heavyweight: Suzhou Successfully Bids for the International Society of Mechanical Circulatory Support Annual Meeting (ISMCS 2026)
TCT 2024 | Professor Ge Junbo's team from Zhongshan Hospital, Shanghai, shares the latest progress of the domestically developed magAssist, the world's smallest interventional ventricular assist system.
The First Extra-VAD Standardized Training Course Successfully Held! Continuously Promoting the Standardized Training and System Construction of Extracorporeal Ventricular Assist Technology in China
magAssist MoyoAssist® Grand Launch! Successful Hosting of the Medium- and Short-Term Mechanical Circulatory Support Forum & Extra-VAD Clinical Technology Transformation Achievements Release

Recognized by Both China and the U.S., Changing the Innovation Trend of Such Devices | magAssist's Minimally Invasive Interventional Artificial Heart Approved as an Innovative Medical Device!


#magAssist  #NyokAssist® #Ventricular Assist Device #IABP  #High-risk PCI

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