CH-VAD Developer Tongxin Medical Advances Global Clinical Rollout with BrioVAD Approved in Austria, Germany, and the Netherlands
BrioHealth Solutions
Ventricular Assist Device Developer and Manufacturer
Pioneer in Medical Device Media Coverage
Sharing Professional Medical Device Knowledge
June 23
BrioHealth SolutionsOfficial Announcement
its independently developed
Next-Generation Fully Magnetically Levitated Implantable
Left Ventricular Assist System BrioVAD
Approved in Austria and Germany, respectively
Conducting European Clinical Trials
Following approval by Dutch regulators in May
BrioHealth Solutions BecomesThe only one in China to achieve
Systematic Clinical Deployment Across China, the United States, and Europe
Artificial Heart Company
As the next-generation fully magnetically levitated artificial heart developed by the company for the global market, BrioVAD utilizes the same implantable blood pump as the CH-VAD, which has already achieved commercial application in China through BrioHealth Solutions. Leveraging the internationally pioneering “discrete magnetic levitation and motor design” along with highly optimized hydrodynamic design, the product features a smaller volume, lighter weight, and thinner profile compared to similar international products, offering significant clinical advantages in reducing blood trauma and minimizing the risk of complications such as hemolysis and thrombosis.
Furthermore, BrioVAD/CH-VAD utilizes the percutaneous lead with the fewest number (4 wires) and the smallest diameter (3.3 mm) globally, resulting in an infection rate that is among the lowest for similar products worldwide. In terms of daily user experience, the extracorporeal components of BrioVAD consist solely of a battery pack and a controller, offering a lightweight, portable, and user-friendly design that significantly enhances patients’ mobility and ease of independent use.
“This pace is no accident, but the result of BrioHealth Solutions’ accumulated experience in global strategic layout and the efficient empowerment provided by its localized professional team,” said Lu Chengjie, CEO of BrioHealth Solutions.
2024
BrioVAD U.S. INNOVATE Clinical Trial
Officially Approved
become the first in China to receive
Approved by the U.S. Food and Drug Administration (FDA)
Active Implantable Medical Devices Entering Clinical Trials
In this process, BrioHealth Solutions has established systematic capabilities that comply with the regulatory rules and approval standards for high-end medical devices in Europe and the United States, and has constructed a standardized and systematic clinical submission process for mainstream overseas markets. Supported by this framework, the company has assembled professional regulatory, clinical, and operational teams to precisely align with the detailed regulatory requirements and submission criteria of various European and American countries, efficiently liaise with national regulatory authorities, and significantly enhance the efficiency of submissions and reviews.
BrioVAD Clinical Trials in Europe
Aimed at systematically evaluating its therapeutic efficacy
of patients with advanced heart failure
Safety and Clinical Performance
This study will be conducted at 12 clinical centers across Europe, aiming to enroll approximately 60 patients. It covers both short-term and long-term mechanical circulatory support scenarios for adults with advanced heart failure, with the primary endpoint being the six-month postoperative survival rate. “Regulatory approval is only the first step; the successful implementation of clinical trials depends on the responsiveness of the research centers and patients,” said Lu Chengjie.
Currently, investigator training has been completed at all nine of the first clinical research centers in Europe. Among them, the University Medical Center Utrecht in the Netherlands successfully performed the first BrioVAD implantation in Europe in early June, marking substantial progress in patient enrollment for the European clinical trial.
Europe is a highly mature market for the global application of left ventricular assist devices (LVADs). As the largest LVAD market in Europe, Germany boasts a well-established clinical diagnosis and treatment system and rigorous research standards, representing the pinnacle of clinical excellence in the treatment of advanced heart failure across Europe. It is reported that the clinical trial of BrioVAD is the first prospective study on a fully magnetically levitated artificial heart conducted in Europe in over a decade.