Source: Heart Future; Editor: Bai Xiaofei
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,BrioHealth SolutionsAnnounced its independently developedNew Generation Fully Magnetically Levitated Left Ventricular Assist System BrioVAD™Approved by the U.S. FDA to Conduct Clinical Trials, this landmark clinical trialINNOVATE StudyHas obtained FDA Investigational Device Exemption (IDE) approval，Patient recruitment can be initiated on certain conditions.。The study will evaluate the novel fully magnetically levitated left ventricular assist system, BrioVAD™, independently developed by BrioHealth Solutions.Efficacy and Safety for Treating Refractory Heart Failure. Meanwhile, BrioHealth SolutionsThe first investigator meeting has been held.AndInitiated the relevant startup work at the U.S. clinical trial center.。
▲BrioHealth Solutions Holds First Investigator Meeting for INNOVATE Clinical Trial
BrioVAD™ Left Ventricular Assist System is a star product of BrioHealth Solutions.ProductCifu®️VADUpgrade iteration on，At the 2023 China High-Performance Medical Device Innovation Ecosystem Summit,BrioHealth SolutionsWith its independently developed fully magnetically levitated artificial heart —— CiFu® Implantable Left Ventricular Assist System (referred to as "CiFu® VAD"), it proudly ascended to the "Top 10 Self-Innovated Medical Device Products in 2023"List,Becoming the only artificial heart enterprise successfully selected。
# BrioVAD™ Left Ventricular Assist System
BrioHealth Solutions' BrioVAD™ Left Ventricular Assist System, which has been approved in the United States this time, is based on the existing product, CiFU® VAD (Model: CH-VAD).Excellent HemocompatibilityOn the basis of, through a number of technological innovations achievedPortable External Components, andOverall system performance has been further improved.. At the same time, the INNOVATE study will adopt a randomized controlled trial design,Comparison and Evaluation of BrioVAD™ with Previously FDA-Approved Products。▲Left Ventricular Assist System BrioVAD™ Product SchematicCH-VAD® Implantable Left Ventricular Assist SystemYesChina's First Self-Developed and ApprovedThe Fully Magnetically Levitated Implantable Left Ventricular Assist DeviceJointly developed by the Fuwai Hospital team and BrioHealth Solutions, weighing 186g, with a blood pump diameter of 50mm, thickness of 26mm, and a maximum flow rate of 10L/min. The ProductThe core technology is mainly the full magnetic levitation blood pump technology., and has obtained multiple patents in China and the United States,A domestically首创 medical device in China。Compared with similar international products, key performance indicators have reached the same level.Smaller blood pump size, superior implant invasiveness。Cifu®VADEntered clinical trials in 2018,Approved by NMPA in 2021Used in conjunction with specific artificial blood vessels to provide mechanical support for blood circulation in patients with advanced refractory left heart failure, serving as a transitional treatment before heart transplantation or for restoring cardiac function.▲CiFu® Implantable Left Ventricular Assist System (CH-VAD)Cifu®VADThe implantable left ventricular assist system consists of intracorporeal implanted components, extracorporeal portable components, peripheral components, and dedicated surgical tools, and is used for partial...An electromechanical integrated device that replaces the heart's pumping function and maintains human blood circulation. ItsThe core component is a blood pump., the blood is drawn from the heart, pressure is increased, and then it is delivered to the aorta, thereby achieving the function of unloading the natural heart's burden, allowing the natural heart to rest. At the same time, it supplements the insufficient pumping capacity of the natural heart.
Since its launch, the BrioHealth Solutions® VADHas been applied in more than 180 patients across 40 top-tier heart disease hospitals in China.，The first patient has survived for more than 6 years and continues to maintain a high quality of life.。BrioHealth Solutions' VAD has complete independent intellectual property rights built from the underlying core technology, and has already obtained patent protection in countries and regions such as China, the United States, Europe, and Japan.# Latest Clinical Data of CiFu®VAD
In April 2024, at the ISHLT session "Spin Doctors and Heart Hotties: Unleashing the Future of MCS Devices," Professor Wang Xianqiang from Fuwai Hospital, Chinese Academy of Medical Sciences, presented the long-term follow-up results of the CiFont® VAD on the international stage for the first time. This single-center, retrospective, observational study...End-stage heart failure patients treated with CiVAD®High survival rate, low complication rate, no cases of pump thrombosis, disabling stroke, or major device malfunction.。To further evaluate the long-term effectiveness and safety of CiFu®VADFuwai Hospital conducted this single-center, retrospective, observational study, enrolling heart failure patients who received treatment with the CiFont® VAD at the center from June 2017 to August 2023, and performed statistical analysis on their clinical data and long-term prognosis.The study enrolled a total of 50 patients, with a follow-up duration ranging from 3 months to 6.7 years.The average pump support time for patients was 2.4 years.，All 50 patients successfully received LVAD implantationDuring and after the surgery, the patient's blood pump operated stably, and hemodynamics returned to normal.Using Kaplan-Meier survival analysis,The 1-year, 2-year, and 3-year survival rates of the patients were 93%, 93%, and 89%, respectively., which are higher than the levels in international clinical research and real-world settings.Among 50 patients, only 2 underwent bridge-to-heart transplantation. In 3 patients, cardiac function fully recovered and the LVAD was removed.
▲Patient Survival Rate During Follow-up Period
▲Incidence Rates of Different Endpoint Events
In this study, the overall incidence of adverse events was low. The excellent hemocompatibility of CiVAD® was demonstrated.No cases of pump thrombosis, hemolysis, or disabling stroke events were observed.。
Among all patients, only 2 cases of ischemic stroke (0.02 per person-year) and 1 case of hemorrhagic stroke (0.01 per person-year) occurred, and the neurological functions of the patients recovered during the follow-up period. The most common adverse event was postoperative infection, which has been effectively prevented and controlled as the team accumulated comprehensive management experience.The vast majority of patients achieved good outcomes under the management of a multidisciplinary team.。No major device malfunctions or pump replacement surgeries occurred during the follow-up period, indicating high long-term reliability of the device.。
▲Incidence Rates of Various Adverse Events
# Comparison of BrioHealth Solutions' VADHeartMate
On April 15, 2024, the U.S. Food and Drug Administration (FDA) issued a notice on its official website regarding artificial vessel occlusion incidents caused by external forces (Entrinsic Outflow Graft Obstruction, or EOGO).Abbott/Thoratec Decides to Recall HeartMate II and HeartMate 3 Implantable Left Ventricular Assist Systems。This recall involves 13,883 sets of devices, accounting for 56% of the total quantity of previously marketed products.The Kaplan-Meier estimated incidence rate of HeartMate 3 EOGO is 0.24% at 2 years and 2.06% at 5 years.The EOGO of HeartMate II and HeartMate 3 involved in this recall is not "news" in the industry. So far, the U.S. FDA has recorded multiple adverse event reports regarding the EOGO of HeartMate, with a total of 273 injury reports and 14 death reports.It should be noted that: firstly,A Class I recall of medical devices by the U.S. FDA does not mean the product will be discontinued or taken out of use, but rather that corrections will be made to address the issues, and it will continue to be used clinically.The SecondThe FDA's Class I recall of HeartMate II and HeartMate 3 was due to the EOGO event.EOGO is caused by the dense reinforced sleeve wrapping around the artificial blood vessels of HeartMate II and HeartMate 3, leading to the accumulation of acellular biological substances, which forces the artificial blood vessels to be squeezed inward., andThe domestic LVAD devices represented by CiFU®VAD have resolved the aforementioned design flaws of HeartMate through an enhanced hollowed-out design of the casing.。Full Magnetic Levitation TechnologyIt can achieve stable idle operation without liquid, and a large number of studies have confirmed this.Can significantly reduce blood damage, thereby significantly reducing the occurrence of related complications such as thrombosis and stroke.。The CiFu® VAD achieves this by placing the motor stator and magnetic suspension stator on the inner and outer sides of the rotor, respectively., ensuring its stable suspension in five degrees of freedom: translation and rotation along the X and Y axes, and translation along the Z axis.Making it have a good impact resistance effect, more stable in long-term operation, and reducing damage to blood.; the optimized flow channel design allows blood to pass through the nasal cone drainage, smoothly transitioning from the inlet tube to the impeller position. The U-shaped secondary flow channel with a 250μm gap is neither too narrow to prevent smooth blood flow nor too wide to generate Taylor vortices, ensuring effective flushing.Beihang UniversityProfessor Zengsheng ChenOnce upon a timeEmphasis: The "culprit" behind this recall is the dense PTFE material reinforcement sleeve used in HeartMate II and HeartMate 3.BrioHealth SolutionsCifu®VADRepresented by BrioHealth Solutions, domestically produced LVAD devices have passedHollow Reinforced Cannula DesignEffectively resolved the issue of artificial blood vessel compression.。
BrioHealth Solutions (referred to as "BrioHealth") was established in 2008.Founded by a team of overseas technology experts returning to China, with its headquarters located in Suzhou, China,The company focuses on the research and development of internationally leading ventricular assist devices (artificial hearts)., promoting the commercialization and sales of artificial hearts globally to benefit a wide range of end-stage heart failure patients.After more than 10 years of independent research and development, and relying on its technical accumulation in the field of fully magnetically levitated artificial hearts, BrioHealth Solutions has completed the development of a new generation of artificial heart CH-VAD® based on full magnetic levitation technology. In this emerging niche market, the company continues to demonstrate its strength as a global technological leader.Dr. Chen Chen, Founder of the CompanyDr. Chen is a Bachelor of Thermal Engineering from Tsinghua University, a Ph.D. in Biomedical Engineering from Sichuan University, a visiting scholar at the University of Tokyo in Japan, and a postdoctoral researcher at Ibaraki University in Japan. He is currently a professor at Soochow University, an expert in the National Major Leading Talent Program, and an executive director of the Mechanical Circulatory Support Branch of the Chinese Society of Biomedical Engineering. Dr. Chen has served as the principal investigator for several high-level, high-funding research projects, including those from the U.S. NIH, the Key Projects of the National 863 Program during the "Eleventh Five-Year Plan," the Ministry of Science and Technology's International Science and Technology Cooperation and Exchange Special Fund, and the thematic projects of the 863 Program during the "Twelfth Five-Year Plan."Dr. Chen has been mainly engaged in the research and development of artificial heart technology and enterprise management since 1996., once engaged in the development of the artificial heart Levacor™ based on magnetic levitation technology, invented a magnetic levitation device and proposed an effective method for multidisciplinary design optimization, making a decisive contribution to Levacor becoming a significant technological achievement at that time.
