FDA Grants "Breakthrough Device" Designation to magAssist's NyokAssist® Interventional Ventricular Assist Device

magAssist's NyokAssist® Interventional Ventricular Assist Device has been granted "Breakthrough Device" designation by the U.S. Food and Drug Administration (FDA), making it the first interventional cardiac device from China to receive this prestigious recognition. This milestone highlights NyokAssist®'s global innovation and clinical potential while expediting its regulatory pathway in the U.S.

FDA Breakthrough Device Designation

The FDA's Breakthrough Device Designation launched in 2015, is designed to accelerate the development and regulatory review of cutting-edge medical technologies. This designation is awarded exclusively to devices addressing unmet clinical needs for life-threatening or severely debilitating conditions, providing significant advantages over existing treatments. Companies receiving this status benefit from priority reviews, regulatory guidance, and commercialization support. Past recipients include innovations from Johnson & Johnson, Abbott, Medtronic, and Boston Scientific.

NyokAssist®: Redefining Interventional Heart Support

For high-risk percutaneous coronary intervention (HRPCI) patients, traditional circulatory support devices face limitations such as vascular complications and restricted applicability in patients with arterial stenosis. NyokAssist® addresses these challenges with:

• Smaller delivery profile (9Fr, ~3mm) – minimizes vascular trauma, bleeding risks, and perioperative complications.

• Expandable impeller technology – post-insertion expansion to >21Fr operational size, enabling higher flow rates (3.5-5L/min) at lower RPMs to reduce hemolysis.

• External motor design – eliminates in-body heating risks, enhances safety, and reduces disposable costs by utilizing reusable high-value components.

Developed in collaboration with Academician Junbo Ge’s team at Fudan University Zhongshan Hospital, NyokAssist® has successfully completed type testing and preclinical animal studies, with clinical trials on the horizon.

A Strategic Step in Multi-Organ Life Support

NyokAssist®'s FDA recognition builds upon magAssist's recent NMPA approvals for its next-generation MoyoAssist® extracorporeal ventricular assist device and BreathMo® ECMO system under China's Innovation Medical Device pathway. With NyokAssist® advancing towards clinical trials, magAssist continues to expand its life support platform, reinforcing its commitment to developing transformative solutions in cardiac and multi-organ support.

magAssist remains dedicated to pioneering life-saving innovations in medical technologies.

References

[1]Sidawy & Perler (2022). Rutherford’s Vascular Surgery and Endovascular Therapy (10th ed.).

[2]Bhuiyan et al. (2023). Percutaneous Coronary Intervention with Impella Support in Cardiogenic Shock. ScienceDirect.