Fuwai Hospital Applied the Third Generation Fully Magnetically Levitated LVAD Independently Developed in China to Treat Critically Ill Patients

In June 2017, a 46-year-old heart failure patient who could not find a suitable donor for heart transplant due to excessive body weight of 99 kg, was hospitalized in the Fuwai Hospital. After being supported by extracorporeal membrane oxygenation (ECMO) for 14 days, he began to show hemodynamic instability. His life was at stake. On the 26th of the same month, Professor Shengshou Hu’s team from Fuwai Hospital obtained the signed Informed Consent From (ICF) and implanted the first third-generation full magnetic levitated VAD for Humanitarian use after Humanitarian Device Exemption (HDE) approved by NMPA via fast-track designation.  After the surgery, the patient was awake on the second day, sat up and ate on the third day, and began to walk around on the fourth day. After completing a series of treatments and training of managing the equipment, the patient discharged with the VAD and returned to normal life. It has been more than 8 months since then.

From June to October 2017, Member Hu’s team had treated three advanced heart failure patients by successfully implanting the third-generation maglev VADs for Humanitarian uses.  The successful treatment with CH-VAD indicates that the domestic VAD field has entered a new era of development bringing new hope for many patients with advanced heart failure.

Heart failure is the end stage of all kinds of heart diseases and is one of the main death contributors for heart disease patients. Ventricular assist device, has become one of the standardized therapies for patients with advanced heart failure recommended by international guidelines, and has been one of the fastest growing areas in the treatment of severe heart failure disease in the past decade. At present, there are three main clinical applications of VAD. One is to serve as a substitute for patients waiting for heart transplantation in the transition period, so patients have longer time to wait for the suitable heart. The second is to provide Short-Term support for patients with acute heart failure, it can be removed after the heart function is restored. The third is to provide Long-Term support for patients with end-stage heart failure.

VAD is a complex and sophisticated medical device, the development has experienced the first generation of large size pulsating flow VAD in the 1990s, the second generation of axial flow device in the early 21st century, and the latest third generation of fully magnetically levitated device. The third generation of ventricular assist device is characterized by magnetic levitation without bearing, which has great clinical advantages of small size thus less surgical trauma, less driveline infection, and good biocompatibility.

Since 2014, Suzhou CH Biomedical. and the State Key Laboratory of Cardiovascular Diseases (SKLCD) have jointly conducted in-depth research on the fully magnetic levitation technology application on blood pump, performed many in-vivo and in-vitro tests, and finalized the prototype. Through 37 large animal studies, the anti-electromagnetic interference, pump operating temperature monitoring, hemocompatibility, surgical tools optimization, and anticoagulation therapy strategy of the device were further optimized. In June 2017, 6 large animal studies with CH-VAD implanted with a survival span of 60 days were reported to the NMPA of China. Currently, the product has entered the "fast track designation” approval path set up for creative medical devices.