FDA Designates NyokAssist™ Ventricular Assist Device as a Breakthrough Innovation
In a significant development in the medical device industry, magAssist’s NyokAssist™ Interventional Ventricular Assist Device (VAD) has been granted breakthrough designation by the U.S. Food and Drug Administration (FDA). The breakthrough designation signifies the FDA’s recognition of NyokAssist™ as a cutting-edge device that offers innovative solutions for patients and healthcare providers in the field of artificial heart technology.
Interventional VADs have proven to be highly effective in providing mechanical circulatory support during high-risk percutaneous interventions. However, their larger insertion size is associated with several complications, including vascular complications, bleeding, blood transfusion, and adverse cardiovascular events. To address these challenges, magAssist’s dedicated team has focused on reducing the interventional size to minimize risks while meeting the clinical demands of the market.
The NyokAssist™ VAD has successfully achieved a 9Fr insertion size, made possible by its unique foldable catheter pump. This innovative design facilitates easier insertion and removal from the body, reducing vascular access and closure processes. Once positioned, the catheter pump unfolds to ensure optimal blood flow. Moreover, the impeller within the pump provides greater hydraulic efficiency, even at lower rotation speeds. Additionally, NyokAssist™ features an external motor placed outside the body, minimizing access size and the risk of motor overheating-induced hemolysis.
Receiving the breakthrough designation from the FDA is a significant milestone for magAssist, highlighting the company’s commitment to pioneering medical technology. This recognition positions NyokAssist™ as a frontrunner in innovation, with magAssist continuously striving to advance medical technology through research and patient-centered solutions that create value for both patients and the medical device industry.
About magAssist:
magAssist is a leading medical device company dedicated to developing circulatory support devices for acute and severe cardiac and pulmonary failure. Their range of products includes extracorporeal ventricular assist devices, interventional ventricular assist devices, extracorporeal membrane oxygenation systems (ECMO), and organ care systems. magAssist’s flagship product, MoyoAssist® Extra-VAD, has completed clinical trial enrollment. The company remains committed to delivering valuable technology to patients and clinicians worldwide.
In conclusion, the FDA’s breakthrough designation for magAssist’s NyokAssist™ Interventional Ventricular Assist Device highlights the device’s cutting-edge capabilities and its potential to revolutionize the field of artificial heart technology. With its commitment to patient-centric innovation, magAssist is driving advancements in medical technology that benefit patients and advance the healthcare industry as a whole.
