After recently being granted breakthrough device designation by the FDA, the latest product from magAssist’s team of medical innovators (in collaboration with Cobalt’s own designers and engineers) has successfully completed its first in-human trial.
The NyokAssist Interventional VAD is a next-generation ventricular assist device providing mechanical circulatory support from within the heart. The innovative technology features a patented folding pump that is inserted via a catheter through the femoral artery in the leg. The device is intended to treat patients with arterial blockages or insufficient blood flow and require a high-risk PCI procedure.
The all-new device builds upon the MoyoAssist®Console – with an all-new external motor, single-use pump, and purge flow unit that is designed to attach to the existing console – reducing cost and development time.
Minimising the interventional size was a key focus during the NyokAssist product development process, reducing both the impact on the patient and the risk of complications. The result is significantly less invasive than current market offerings, achieving a 9Fr insertion size (just 3mm!).
FDA Breakthrough Device Designation
In August, the NyokAssist was granted designation as a breakthrough device by the US FDA. The Breakthrough Devices Program aims to get medical devices that offer more effective treatment than current offerings into medical practices quickly by speeding up development, assessment, and review.
This is a huge achievement and one that reaffirms the level of innovation and drive for improvement to patient outcomes that magAssist strive for when developing new technologies.
First Human Clinical Trial
More recently in September, the device was used in its very first in-human clinical trial. The device was used to support a 48-year-old male who was diagnosed with coronary artery disease (CAD), heart failure, type II diabetes and post-PCI. A high-risk PCI surgical procedure was performed to implant two stents and to remove arterial lesions, during which the NyokAssist provided mechanical circulatory support for a total of 1 hour and 12 minutes.
The procedure was a success. The patient was able to stand within 6 hours of the procedure and was discharged within 2 days – and made a full recovery.
Huge congratulations to magAssist and everyone involved in the project (including our own team). We are excited to see this product continue to make a life-changing difference in years to come. Follow magAssist to hear more about future updates.
See more About our MedTech projects
MoyoAssist® Console – The platform for the all-new NyokAssist Interventional VAD
magAssist has been at the forefront of cardiovascular and life support technology since their inception in 2017. Following the development of the award-winning MoyoAssist® Extra-VAD, Cobalt has continued to work closely with magAssist, providing product design and engineering assistance for their innovative medical technology.
