Corvia Medical today announced three-year positive results from its clinical trial of its Corvia Atrial Shunt.
The REDUCE LAP-HF randomized trial evaluated the safety and efficacy of an atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. The group of patients had no latent pulmonary vascular disease or a cardiac rhythm management device.
The results were published in The American Heart Journal.
At three years, patients who received the Corvia Atrial Shunt experienced 44% fewer combined inpatient and outpatient heart failure events compared to the control group. The company said the shunt group also reported a clinically meaningful 2.5 times greater improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score, indicating improved quality of life with less fatigue, reduced shortness of breath and fewer activity restrictions. There were no significant safety concerns identified with the Corvia Atrial Shunt.
“What we’ve learned from this three-year data set is that the Corvia shunt results are not only strongly positive but demonstrably durable,” said Dr. Sheldon Litwin, Alicia Spaulding-Paolozzi Professor of Cardiology at Medical University of South Carolina and a lead researcher in the trial. “The absolute risk reduction for total heart failure events actually improves year by year over the two-year and one-year statistics. And with a majority of patients emphasizing quality of life even over reduced hospitalizations, the importance of the sharply improved KCCQ scores is magnified.”
More than 26 million people globally have heart failure, and the majority of patients have HFpEF. Corvia Medical said the condition is one of the largest unmet clinical needs in cardiovascular medicine.
The Corvia Atrial Shunt reduces elevated left atrial pressure, which is the primary contributor to heart failure symptoms in HFpEF patients. It creates a passage between the left and right atria, reducing heart failure events and improving quality of life.
“We are confident that the strong three-year results will generate continued enthusiasm for atrial shunting among referring physicians, positioning it as a promising treatment option for eligible HFpEF patients,” said Jan Komtebedde, Chief Medical Officer at Corvia Medical.
