MagAssist’s NyokAssist Interventional Ventricular Assist Device Used in FIH High-Risk PCI

September 5, 2023—MagAssist Co., Ltd, a China-based developer of circulatory support devices for acute/severe cardiac and pulmonary failure, announced the successful first-in-human use of the company’s NyokAssist, supporting high-risk percutaneous coronary interventions (PCI). The procedure initially confirmed the safety and effectiveness of NyokAssist in assisting high-risk PCI, stated the company.

Junbo Ge, MD, and colleagues from Zhongshan Hospital in Shanghai, China, performed the procedure.

According to MagAssist, the patient was a man in his late 40s who was diagnosed with coronary artery disease, heart failure, type II diabetes, and post-PCI before the procedure. Preoperative echocardiography showed left ventricular enlargement with decreased left ventricular systolic motion, with a left ventricular ejection fraction of 34%. The study procedure was authorized by the patient’s consent and was anonymized to ensure the protection of individual confidentiality, advised the company.

As noted in the company’s press release, with 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. The team decided to perform PCI with the support of NyokAssist.

The company reported that the procedure went well. With the insertion of the 9-F sheath, NyokAssist was easy to deliver through the aortic arch and valve, causing less invasive injury compared with the currently available devices. NyokAssist effectively ensured safety and effectiveness throughout the procedure, providing an average flow of > 3 L/min. The patient’s blood pressure was stable during the procedure. The patient’s recovery culminated in discharge at 2 days after the procedure. Further details of the procedure are available in the company’s announcement online.

The FIM procedure comes after MagAssist’s recent announcement that NyokAssist has received FDA Breakthrough Device designation. NyokAssist has not received approvals from either the FDA in the United States or the National Medical Products Administration in China, advised the company.