Recently, NyokAssist™ was first-in-man (FIM) use, supporting High-risk PCI completed by Dr. Junbo Ge’s team from Zhongshan Hospital in Shanghai. This successful implementation of HRPCI initially confirmed the safety and effectiveness of NyokAssist™ in assisting high-risk PCI.
The patient is a 48-year-old male, who was diagnosed with coronary artery disease (CAD), heart failure, type II diabetes, and post-PCI before surgery. Preoperative echocardiography showed left ventricular enlargement with decreased left ventricular systolic motion, with an LVEF of 34%. (Note: The case study has been authorized by the patient’s consent and has been anonymized to ensure the protection of individual confidentiality.)
Given the patient’s complicated medical condition and high surgical risk, Dr. Ge’s team evaluated the possible hemodynamic disorders during the procedure, requiring mechanical circulatory support, and decided to perform PCI with the support of NyokAssist™. Eventually, the procedure went well. With the insertion of the 9Fr sheath, NyokAssist™ was easy to deliver through the aortic arch and valve, causing less invasive injury compared with the current product in the market. It effectively ensured safety and effectiveness through the procedure, providing an average flow of more than 3L /min. The patient’s blood pressure was stable during the procedure. A testament to innovation, the patient’s recovery culminated in discharge 2 days after the procedure.
Coronary artery disease (CAD) has been on the rise since the last decade in China, the number of PCI cases increased steadily to 1.5 million in 2022, of which high-risk PCI cases account for over 10%. Such operations have a high mortality rate. The persistent challenge lies in a lack of secure and effective intraoperative protection during clinical practice. The interventional VAD becomes a pivotal solution for maintaining the stability of intraoperative hemodynamics, securing the success of the operation, and optimizing postoperative outcomes.
The FIM use has been an exciting milestone for magAssist, showing that magAssist devotion to transforming innovations into lifesaving technologies has come to fruitful results. Furthermore, NyokAssist™ has recently received designation from the U.S. FDA’s Breakthrough Device Program, underscoring its potential on the global stage.