CH-VAD Developer Corheart Receives FDA Approval for Brio4Kids Pediatric Clinical Trial, Expanding Global Footprint in Pediatric Heart Failure
Recently, BrioHealth Solutions, the wholly-owned U.S. subsidiary of Tongxin Medical, announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical evaluation of the BrioVAD® system in pediatric patients with advanced heart failure. As an extension of the INNOVATE trial into the pediatric population, the Brio4Kids trial will be conducted under the latter’s Investigational Device Exemption (IDE). This milestone not only marks the first prospective clinical trial of a fully magnetically levitated artificial heart in pediatric patients but also represents the first time that the same left ventricular assist device (LVAD) is being evaluated in parallel in both adult and pediatric populations, thereby addressing a critical gap in the treatment of heart failure in children.
According to a recently published epidemiological study on pediatric heart failure,1, by 2021, the global number of children and adolescents aged 0–20 years with heart failure had reached 6.01 million, with a steadily increasing prevalence year by year; pediatric heart failure has become a major public health concern worldwide. Previous large-scale cohort studies have shown2，3, the 1- and 5-year transplant-free survival rates for children diagnosed with dilated cardiomyopathy are 69%–72% and 54%–63%, respectively. In particular, these patients face a substantial risk of death or heart transplantation within the first year after diagnosis, posing a serious threat to their life and health. Although heart transplantation is considered the primary treatment for end-stage heart failure, its actual benefit for pediatric patients is very limited due to the severe shortage of donor organs. According to the 2021 International Society for Heart and Lung Transplantation (ISHLT) Report on Pediatric Heart Transplantation4, from 2010 to June 2018, there were only 5,307 pediatric heart transplants worldwide, with fewer than 700 procedures performed annually, far failing to meet clinical demand.
Against this backdrop, artificial heart technology continues to advance, gradually becoming a critical solution for children with end-stage heart failure. Currently, these patients commonly face a “no pump available” dilemma: the only durable left ventricular assist device (LVAD) approved in the United States, Abbott’s HeartMate 3, is too large for most pediatric patients, while smaller devices often fail to support discharge from the hospital.
Addressing this unmet clinical need, Tongxin Medical is advancing the BrioVAD®Based on clinical studies for adult indications, conditional FDA approval was obtained to initiate the Brio4Kids pediatric clinical trial. The prospective Brio4Kids clinical trial will facilitate the expansion of indications to individuals under 18 years of age, in order to evaluate BrioVAD®Safety and Efficacy of the System in Pediatric Patients with Refractory Left Ventricular Failure in Late Childhood. This clinical trial is a prospective, multicenter, single-arm study to be conducted jointly at seven leading pediatric heart centers in the United States and two centers in Japan, with a planned enrollment of 25 to 65 patients. The study population primarily comprises pediatric patients with New York Heart Association (NYHA) Class IV cardiac function who require mechanical circulatory support and are either listed for heart transplantation or meet the criteria for heart transplantation. During the trial design phase, the research team performed three-dimensional reconstruction and simulated implantation assessments based on CT imaging data from multiple pediatric cases, and the results demonstrated that BrioVAD®The system demonstrates favorable implant compatibility in children with a body surface area ≥0.8 m², achieving reliable anatomical matching. This further validates its application potential in the pediatric population and provides an important basis for the design of inclusion criteria and clinical pathways.
Figure Caption: First Training Session for the Brio4Kids Pediatric Clinical Trial in April 2026
BrioVAD®As a brand-new product developed by Tongxin Medical based on its marketed CH-VAD, it is the first active implantable medical device in China to receive U.S. FDA approval for clinical trials. The INNOVATE clinical study conducted in the United States is the world’s first large-scale “head-to-head” clinical trial of a fully magnetically levitated artificial heart. Currently, BrioVAD®The INNOVATE clinical trial for adults has completed enrollment of over 150 patients at multiple leading clinical centers in the United States, including BrioVAD®The system has been implanted in over 100 cases, providing robust technical and data support for the advancement of subsequent pediatric clinical trials.
Leveraging the internationally pioneering “discrete magnetic levitation and motor design” and highly optimized hydrodynamic design, BrioVAD®Compared with similar international products, it features a smaller size, lighter weight, and thinner profile, resulting in less blood damage and fewer complications such as hemolysis and thrombosis. It is also equipped with the fewest (4) and thinnest (3.3 mm in diameter) percutaneous cables globally, maintaining the lowest infection rate reported in global public literature. In addition, BrioVAD®BrioVADThe external components consist of only a battery and a controller, making it lighter and easier to operate than Abbott’s HeartMate 3.®With its ultra-compact design and lightweight, wearable accessories, the system is poised to deliver novel therapeutic options for the pediatric population, an underserved group with urgent unmet needs.
Dr. Angela Lorts, Professor of Heart Failure at Cincinnati Children’s Hospital Medical Center and the study’s principal investigator, stated, “The lack of durable left ventricular assist device (LVAD) options for pediatric heart failure patients (including school-aged children) has long been a significant challenge, reflecting a substantial unmet clinical need. We are highly enthusiastic about exploring BrioVAD through the Brio4Kids study.”®The system’s clinical application potential.”
Dr. Chen Chen, Founder and Chairman of Tongxin Medical, stated, “The launch of the Brio4Kids study represents a key milestone in Tongxin Medical’s drive toward product internationalization. It is our unwavering corporate responsibility to provide high-quality medical products and solutions to heart failure patients worldwide. The implementation of this clinical study marks another significant breakthrough in our journey to become a global innovation leader in the field of artificial hearts and to build a top-tier industry service system.”
The U.S. clinical trial for Brio4Kids is expected to commence participant enrollment in mid-2026, with preliminary data anticipated in the fourth quarter. As the study progresses, Tongxin Medical will continue to maintain close collaboration with clinical researchers, the FDA, and other stakeholders in the healthcare industry.
References
1.Yuan Y, Li C, Lei S, et al. Global Burden and Disparities in Pediatric Heart Failure: 1990-2021. JACC Heart Fail. 2025 Aug;13(8):102484. doi: 10.1016/j.jchf.2025.03.032.
2.Towbin JA, Lowe AM, Colan SD, et al. Incidence, causes, and outcomes of dilated cardiomyopathy in children. JAMA. 2006 Oct 18;296(15):1867-76. doi: 10.1001/jama.296.15.1867.
3.Daubeney PE, Nugent AW, Chondros P, Carlin JB, Colan SD, Cheung M, Davis AM, Chow CW, Weintraub RG; National Australian Childhood Cardiomyopathy Study. Clinical features and outcomes of childhood dilated cardiomyopathy: results from a national population-based study. Circulation. 2006 Dec 12;114(24):2671-8. doi: 10.1161/CIRCULATIONAHA.106.635128.
4.Singh TP, Cherikh WS, Hsich E, et al. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Twenty-fourth pediatric heart transplantation report - 2021; focus on recipient characteristics. J Heart Lung Transplant. 2021 Oct;40(10):1050-1059. doi: 10.1016/j.healun.2021.07.022.