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The REDUCE LAP-HF II trial is the world's first phase III trial to evaluate safety and efficacy of an atrial shunt in heart failure patients. The study of 626 patients previously identified a responder group, representing half of all study participants, who experienced a significant reduction in heart failure events and an improvement in quality of life at one year. The two-year results confirmed that this benefit was sustained in this group.
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Finn Gustafsson, MD, Professor of Cardiology at University of Copenhagen commented on the findings: "The two-year REDUCE LAP-HF II findings demonstrate the longer-term safety of the Corvia Atrial Shunt and support what we observed at one year, that in properly selected patients, atrial shunting appears to have lasting clinical benefit in the reduction of heart failure events."
Sanjiv Shah, MD from Northwestern University Feinberg School of Medicine and co-principal investigator for the trial added: "The 24-month results from the REDUCE LAP-HF II trial provide further assurance of the safety and efficacy of the Corvia Atrial Shunt." He expressed optimism that this device has potential to deliver significant long-term benefits to a large proportion of heart failure patients.
Jan Komtebedde, Chief Medical Officer at Corvia Medical said: "We are excited about the two-year outcomes in the responder group as they provide strong evidence that we have successfully identified those heart failure patients who will benefit most from atrial shunting." He added that they are currently recruiting patients into RESPONDER-HF study - a confirmatory, randomized, sham controlled trial - which will provide additional evidence required to make this therapy available to a broader patient population.
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