Aussie heart failure technology hits next stage of commercialisation path

MedTech & Diagnostics News: An innovative Australian technology has made significant strides in clinical trials, offering new hope for patients with end-stage heart failure.

BiVACOR, in collaboration with the Texas Heart Institute (THI), has announced the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH) as part of the U.S. Food and Drug Administration (FDA) early feasibility study (EFS).

Heart failure (HF) is a devastating condition affecting over 300,000 Australians and 11 million people in the US and Europe, with 1.1 million new cases reported annually. For those with severe heart failure, the prognosis is often grim without intervention. While a heart transplant could provide a solution, more than 90% of heart failure patients are ineligible for this procedure and require long-term circulatory support to survive.

BiVACOR’s TAH is a cutting-edge device constructed from titanium, featuring a biventricular rotary blood pump with a single moving part. It uses a magnetically levitated rotor to pump blood and replace both ventricles of a failing heart.

“The Texas Heart Institute is enthused about the groundbreaking first implantation of BiVACOR’s TAH. With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant,” said Dr Joseph Rogers, President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research.

“We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”

The initial human clinical study is designed to assess the safety and performance of the BiVACOR TAH as a bridge-to-transplant solution for patients with severe biventricular or univentricular heart failure, particularly where left ventricular assist device support is not viable.

Dr Daniel Timms, Founder and Chief Technology Officer of BiVACOR, stated “I’m incredibly proud to witness the successful first-in-human implant of our TAH. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute.”

He further added, “Utilising advanced MAGLEV technology, our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant. I look forward to continuing the next phase of our clinical trial.”

BiVACOR has also secured approximately $2 million in funding from MTPConnect’s Targeted Translation Research Accelerator (TTRA) and industry contributions to support this research.

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