Corvia Medical has announced positive safety and efficacy results from its REDUCE LAP-HF II randomised Phase III trial. The data, presented at the European Society of Cardiology (ESC) Heart Failure 2023 conference in Prague, Czech Republic, demonstrated patients benefited two years on from therapy.
According to Corvia, REDUCE LAP-HF II (NCT03088033) is the world’s first phase III trial to evaluate safety and efficacy of an atrial shunt in heart failure patients. After initial identification of an initial responder group that constituted half of the 626 participants with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction, clinical benefit was sustained two years after Corvia atrial shunt device insertion.
Compared to sham control, patients showed a significant 50% reduction in the rate of heart failure events and a sustained improvement in quality of life according to the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score.
“The 24-month results from the REDUCE LAP-HF II trial provide further assurance of the safety and efficacy of the Corvia Atrial Shunt,” said Sanjiv Shah, MD, Northwestern University Feinberg School of Medicine, co-principal investigator of the trial.
“We are currently recruiting patients into the RESPONDER-HF study, a confirmatory, randomised, sham-controlled trial at up to 60 centers across the US, Europe, and Australia. We believe the results from this trial will provide the additional evidence required to make the therapy available to a broader patient population,” said Jan Komtebedde, Chief Medical Officer at Corvia Medical.
Research published in the Circulation estimates that the total direct medical costs of cardiovascular disease between 2012 to 2030 are projected to increase from $396bn to $918bn.