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A “Chinese heart” could be helping to save lives in the United States despite efforts to decouple the two countries’ biotechnology sectors as a result of rising political tensions.
The fully magnetically levitated pump, which is slightly bigger than a table tennis ball, has been fitted to more than 100 patients with advanced heart failure across the United States as part of a nationwide clinical trial.
The BrioVAD is a left ventricular assist device (LVAD) that helps pump oxygen-rich blood to the rest of the body when the heart becomes too weak to do so.
In 2024, it became the first active implantable medical device from China to receive Food and Drug Administration approval for clinical trials in the US.
In a paper published last August, the trial team said that the trials were “designed to evaluate the safety and efficacy of the BrioVAD by demonstrating non-inferiority to HeartMate 3”.
The HeartMate 3 manufactured by Abbott is currently the only commercially available LVAD in the US.
The BrioVAD pump – described as the “Chinese heart” by the official Science and Technology Daily – is 20 per cent smaller than the HeartMate 3 yet can pump the same amount of blood.
It also has a slightly narrower cable to connect the pump through the skin to the external battery pack.
“Given the recent risks of supply chain disruptions for medical devices and the unanticipated potential for durable LVAD recalls, the commercial availability of only one durable LVAD in the US raises patient safety concerns, limits provider and patient choices, and impacts innovation in the field,” the team wrote in the peer-reviewed Journal of Heart and Lung Transplantation.
“Thus, there is a significant need for introduction of novel technologies that may afford improvement in patient outcomes, provide more options for patients and providers and advance a more competitive technological environment.”
By April, more than three-quarters of the top 30 US hospitals by volume for artificial heart implants had joined the trial, according to Science and Technology Daily.
The registry ClinicalTrials.gov, run by the US National Library of Medicine, shows that the study has 37 locations, including Emory University in Atlanta, Georgia, which performed the first operation in the US to implant the device.
In January, Emory’s healthcare team celebrated the one-year anniversary of the procedure for a 33-year-old patient who experienced heart failure and severe shortness of breath.
They said “the hope is that this device may be used as a lifelong option for patients or as a bridge to transplant”.
Another trial location, AdventHealth in Orlando, Florida, said patients would undergo eligibility screening for the trial after they were approved for LVAD therapy.
“Then, our financial coordinators will reach out to their insurance to see if they have trial coverage. If they do, we’ll talk to the patient to see if they’re interested in participating in a clinical trial. Most of the patients who have been approached about the study have been excited to participate,” principal investigator Andrija Vidic at the AdventHealth Transplant Institute said in a statement in January.

According to developer CH Biomedical, the trial has been approved for Medicare coverage, the US health insurance programme for people aged 65 or older, with an average cost of US$220,000 per patient.
The company, which has its headquarters in Suzhou in eastern China and a subsidiary in Los Angeles, said that in the random selection process of the trial, participants had a two in three chance of receiving the BrioVAD System.
While the US trial continues to gather data, the device has been supported by long-term clinical outcomes in China.
“The BrioVAD System is a recent evolution from the CH-VAD that was studied and approved for marketing in China since 2021,” its trial team said.
A study of 50 patients who had the CH-VAD implanted between 2017 and 2023 showed a 93 per cent survival rate after one year and 89 per cent after three years, with no major device malfunctions reported during the follow-up period, according to a 2024 paper by researchers at the Fuwai Hospital in Beijing, the world’s largest cardiovascular science centre.
According to the company, more than 300 patients outside the US have received the device.
In June, a patient with advanced heart failure became the first person in Europe to receive a BrioVAD implantation in the Netherlands as part of a European clinic trial, according to the University Medical Centre Utrecht.
The scope of trials is also widening to children with advanced heart failure. In April, BrioHealth said it had received conditional approval for a trial to evaluate the technology for children.


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How a ‘Chinese heart’ could get US blood pumping despite biotech decoupling

Heart patients can hopefully use the device for life or as a “bridge to transplant”. Photo: Shutterstock

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News

China

The BrioVAD pump is the first implantable device from China to receive approval for clinical trials in America


The BrioVAD pump is the first implantable device from China to receive approval for clinical trials in America.


The Netherlands

United States

US Food and Drug Administration (FDA)

How a ‘Chinese heart’ could get US blood pumping despite biotech decoupling

.css-1c6uqr6{color:inherit;font-weight:inherit;font-size:inherit;font-family:inherit;line-height:inherit;overflow-wrap:break-word;}The BrioVAD pump is the first implantable device from China to receive approval for clinical trials in America

The BrioVAD pump is the first implantable device from China to receive approval for clinical trials in America