Professor Song Lei's Team at Fuwai Hospital Completes First Enrollment for TeleVad P35

Recently, significant progress has been made in the clinical trial of the percutaneous Ventricular Assist Device TeleVad P35, developed by Bionic Technology Co., Ltd. The Fuwai Hospital of the Chinese Academy of Medical Sciences, a sub-center in the trial, has enrolled its first patient. Professor Song Lei's team successfully performed a complex high-risk PCI procedure on the patient with the support of the TeleVad P35, marking another milestone in the independent innovation journey of China's high-end medical devices.

TeleVad P35: Addressing the Clinical Pain Points of High-Risk PCI

The pVAD is a high-end innovative medical device designed for circulatory support in patients undergoing treatment for cardiogenic shock or high-risk Percutaneous Coronary Intervention (PCI). Through its unique working mechanism, it actively reduces the cardiac workload while ensuring coronary artery and vital organ perfusion during the procedure, thereby significantly lowering the risks associated with high-risk PCI.

The clinical trial for Tongling Bionic's TeleVad P35 is led by Academician Wang Jian'an, a renowned cardiologist from the Second Affiliated Hospital of Zhejiang University School of Medicine, serving as the Principal Investigator (PI). The trial is being conducted simultaneously across multiple leading medical centers, including Fuwai Hospital. Its primary objectives are to evaluate the device's safety and efficacy in providing hemodynamic support for high-risk PCI patients, building a solid evidence-based medical foundation for its eventual widespread clinical application.

Kick-off Meeting: Top Experts Lay Groundwork for Surgical Success

During the kick-off meeting held on the day of the sub-center's initiation, Fuwai Hospital convened a distinguished panel of experts. Attendees included Dr. Song Lei, Director of the Cardiology Department; Dr. Zhang Yin, Director of the First Coronary Heart Disease Ward; Dr. Wang Xianqiang, Director of Cardiac Surgery; Dr. Fang Jie and Dr. Zhang Yongbao from the Vascular Surgery Department; Dr. Ji Bingyang and Dr. Liu Gang from the Extracorporeal Circulation Department; and Dr. Duan Fujian from the Ultrasound Department. The experts engaged in in-depth discussions regarding the core aspects of the trial, including the protocol, inclusion and exclusion criteria, follow-up procedures, and quality control measures. Their aim was to ensure the trial's scientific design, standardized operation, and data integrity, laying a robust foundation for the successful execution of the first procedure.

Successful First Surgery: Bringing New Hope to a Critically Ill Patient

Following comprehensive evaluation, the project enrolled its first patient. The patient, a 53-year-old female, presented with complaints of chest tightness and shortness of breath for several months, to the point of being unable to lie flat. She had previously sought treatment at a local hospital, where she was diagnosed with severe pneumonia, acute heart failure, coronary heart disease, acute coronary syndrome, severe coronary artery stenosis, and significantly reduced cardiac function. Showing little improvement after initial treatment, she came to Fuwai Hospital for further management and was admitted to the First Coronary Heart Disease Ward with diagnoses including "acute inferior myocardial infarction, post-coronary stent implantation, coronary heart disease, heart failure, diabetes, and hypertension."

Preoperative ECG revealed sinus rhythm, abnormal Q waves, ST-T changes, and a prolonged QT interval. Echocardiography showed an ejection fraction (EF) of 30%, cardiac output of 3.8 L/min, cardiac index of 2.25, left atrial enlargement, reduced left ventricular systolic function, mild aortic and mitral regurgitation, and regional wall motion abnormalities.

Surgical Challenges:

The patient presented with severe multivessel coronary disease: LAD proximal 60-70% stenosis, proximal-mid 90-95% stenosis; LCX proximal 90-95% stenosis, distal subtotal occlusion; RCA mid 90-95% stenosis; PDA proximal diffuse 80-90% stenosis; PLA proximal subtotal occlusion. The procedure carried a high risk of exacerbated heart failure, malignant arrhythmias, and potentially severe myocardial infarction or death.

Surgical Procedure:

Under local anesthesia, the right femoral artery was accessed, and a sheath was placed. Guided by DSA, the P35 cardiac catheter pump was advanced retrogradely across the aortic valve into the left ventricle, establishing a left ventricle-to-ascending aorta drainage pathway. Once correctly positioned, the TeleVad system was activated, providing flow support of approximately 1.4 L/min. Subsequently, the high-risk PCI procedure was performed. The entire operation lasted about 120 minutes. Thanks to the surgical team's exceptional skill and the support of the TeleVad system, the procedure was a complete success. The patient remained hemodynamically stable throughout the operation and postoperatively, experienced no adverse events, and was successfully discharged from the hospital.

Technological Advancement: Developing the Next-Generation Interventional Ventricular Assist Device

In recent years, the number of heart failure patients, predominantly due to coronary heart disease, has been rising rapidly. However, pharmacological treatments have limited efficacy, and mortality rates remain high. Driven by substantial clinical needs and technological progress, mechanical circulatory support devices that assist the heart's pumping function have emerged, with interventional ventricular assist devices being a focal point of development.

Tongling Bionic is dedicated to becoming a provider of integrated, full-lifecycle solutions for heart failure. As one of the earliest companies in China to venture into pVAD, the company has, through years of dedicated technological research and meticulous development, launched multiple models including TeleVad P50, P35, and RP to meet diverse clinical requirements.

The product utilizes a proven and reliable internally placed motor design. Through extensive theoretical calculations, modeling simulations, and experimental studies, the company has achieved a series of breakthroughs in key technologies such as hemodynamic and blood damage profile optimization, as well as in the design and manufacturing of core components including micro motors, low-hemolysis impellers, and novel anticoagulation/cooling systems. Holding fully independent intellectual property rights, the project has been selected for the national "14th Five-Year Plan" key R&D program and has entered the National Medical Products Administration (NMPA) Innovative Medical Device Special Review Process.

Currently, the P50 model from this series has completed clinical trials and is expected to receive market approval in 2026. The clinical trial for the P35 model is rapidly progressing nationwide. The translation of this innovative achievement into clinical practice holds significant promise for providing more effective and accessible treatment options for heart failure patients in the future.