Medical technology leaders are advocating for international consensus on technical standards for left ventricular assist devices (LVADs), commonly known as partial artificial hearts. This call for clarity emerged from high-level discussions at the 31st annual meeting of the International Society for Mechanical Circulatory Support (ISMCS) in Vienna, where Chinese and international medical device companies convened to address growing concerns about inconsistent terminology and performance evaluation methods.
LVAD technology has become a critical treatment for approximately 60 million people worldwide suffering from heart failure. These mechanical pumps assist the heart’s left ventricle in circulating blood to the aorta, serving as either a bridge to transplantation or as long-term therapy for patients ineligible for heart transplants.
The United States previously dominated the field with fully magnetically levitated bearing systems that suspend the pump’s impeller using magnetic forces. This contact-free design maximizes durability while minimizing damage to blood cells. In a significant industry shift, Chinese medical institutions have emerged as major innovators over the past decade. BrioHealth Technologies became one of only two companies globally to receive FDA approval for clinical trials of fully magnetically levitated pumps.
Marvin Slepian, former chairman of ISMCS, noted that Chinese companies are making ‘dramatic advances’ in the technology. Nobuyuki Kurita, associate professor of surgery at Baylor College of Medicine, observed that Chinese firms are developing at ‘shockingly fast’ rates with substantial investment capacity, benefiting both the industry and patients.
The urgency for standardized definitions follows concerns that some manufacturers have misrepresented their technology. Certain companies have allegedly marketed products with hydrodynamic bearings as fully magnetically levitated systems, creating confusion among clinicians and researchers.
This lack of clarity has hindered effective communication between industry experts, research teams, and medical practitioners, potentially affecting patient outcomes. Slepian emphasized the critical need for transparency, comparing the situation to purchasing an electric vehicle but receiving a combustion engine car instead.
Chen Chen, founder of BrioHealth Technologies, supported the push for standardized definitions to ensure proper technological development. The international medical community anticipates further progress at next year’s ISMCS meeting, which is expected to be held in China, featuring dedicated symposiums on establishing consistent technical standards.