Corvia Medical

[Image from Corvia Medical]Corvia Medical announced that it randomized the first patient in its Responder-HF global confirmatory trial of its atrial shunt.

Tewksbury, Massachusetts-based Corvia designed its shunt for heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.

Dr. Scott Lilly and Dr. Rami Kahwash enrolled and randomized the first patient at the Ohio State University Wexner Medical Center. In a news release, Lilly noted that atrial shunt therapy could “represent significant clinical benefit” for millions of patients.

“Despite ongoing pharmaceutical advances, the treatment of HFpEF remains challenging, and multiple therapies are needed to treat such a heterogenous disease,” said Kahwash. “We are pleased to offer access to a novel treatment option that has the potential to relieve our patients’ breathlessness and improve their quality of life.”

About Responder-HF

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[Image from Corvia Medical]Corvia Medical announced today that it closed a $54 million equity financing from its existing investor syndicate.

Tewksbury, Massachusetts-based Corvia Medical earmarked the funds to support a confirmatory trial to build upon data and learnings from the clinical trial of its Corvia atrial shunt in heart failure patients with preserved (HFpEF) or mildly reduced HFmrEF ejection fraction.

Corvia’s atrial shunt is placed via catheter between the left and right atria to create a passage through which blood is allowed to flow from the high-pressure left atrium to the lower-pressure right atrium. potentially reducing HF symptoms and events and improving quality of life.

In April, Corvia published positive results from its global, phase III Reduce LAP-HF II randomized trial for the atrial shunt, having just two months prior reported that results from the same trial demonstrated that the atrial shunt device did not reduce heart failure ra…

[Image from Corvia Medical]Corvia Medical today announced positive data from the global phase III clinical trial of its atrial shunt in heart failure patients.

Tewksbury, Massachusetts-based Corvia published analyses from its global, phase III Reduce LAP-HF II randomized trial of heart failure (HF) patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction online in Circulation.

According to a news release, in a large responder population representing 50% of study patients, treatment with the Corvia atrial shunt resulted in a 45% reduction in HF events and a 55% greater improvement in quality of life compared to sham control.

Positive data will be welcome news for the company after, two months ago, Corvia reported that results from the same trial demonstrated that the atrial shunt device did not reduce heart failure rates or improve health status.

The company said the data also offers new insights into the role of exercise in accura…

Corvia Medical’s atrial shunt device did not reduce heart failure rates or improve health status in a 626-patient study published on The Lancet’s website.

The REDUCE LAP-HF II results appear to be bad news for Tewksbury, Massachusetts-based Corvia — as well as Edwards Lifesciences, which agreed in 2019 to pay $35 million for the rights to acquire the company.

The 626 patients in the Corvia-funded study were randomly assigned to either the atrial shunt device or sham procedure. The study were no differences between groups in the primary composite endpoint or in the individual components of the primary endpoint.

Corvia Medical in a news release focused instead on results involving the subgroup of patients who had no pacemaker and normal exercise pulmonary vascular resistance, which indicates the absence of pulmonary vascular disease (PVD). The subgroup saw a statistically significant reduction in heart failure events compared to sham (0.12 vs. …