PR95294

TEWKSBURY, Mass., April 1, 2022 /PRNewswire=KYODO JBN/ --

Landmark trial advances understanding of which HFpEF patients may benefit from

atrial shunt therapy

Corvia Medical, Inc, a company dedicated to transforming the treatment of heart

failure (HF), announced publication of analyses from its global, phase III

REDUCE LAP-HF II randomized trial of heart failure patients with preserved

(HFpEF) or mildly reduced (HFmrEF) ejection fraction. In a large responder

population, representing 50% of study patients, treatment with the Corvia (R)

Atrial Shunt resulted in a 45% reduction in HF events and a 55% greater

improvement in quality of life compared to sham control. Additionally, these

data offer essential new insights into the role of exercise in accurately

predicting patients who may or may not benefit from this novel therapy. The

analyses were published online in Circulation1 (

https://c212.net/c/link/?t=0&l=en&o=3491641-1&h=2990568309&u=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F35354306%2F&a=Circulation1

)

Photo - https://mma.prnewswire.com/media/1778510/4x5_Still01.jpg

Logo - https://mma.prnewswire.com/media/224540/corvia_medical_logo.jpg

"We are extremely encouraged by these analyses from the REDUCE LAP-HF II trial.

Not only have we identified a large responder group comprising two-thirds of

people with HFpEF, or approximately 2 million people in the US alone, but we

have also learned how to identify potential patients who are most likely to

derive significant benefit," said Sanjiv Shah, MD, Professor of Medicine,

Director of Research for the Bluhm Cardiovascular Institute, Director of the

HFpEF Program at Northwestern University Feinberg School of Medicine and

co-principal investigator of the REDUCE LAP-HF II trial.

More than 26 million people worldwide have HF,2 and over half those have

HFpEF,3 which has been described as the largest unmet clinical need in

cardiovascular medicine. The Corvia Atrial Shunt is designed to reduce elevated

left atrial pressure (LAP), the primary contributor of HF symptoms in HFpEF

patients. The shunt is placed via catheter between the left and right atria,

forming a passage that allows blood to flow from the high pressure left atrium

to the lower pressure right atrium, with the aim of reducing HF symptoms and

events and improving quality of life.

Barry Borlaug, MD, Professor of Medicine, Director of Circulatory Failure

Research at Mayo Clinic and lead author of the publication commented, "Exercise

hemodynamic evaluation appears to be a key factor in predicting which patients

will do well with atrial shunt therapy. Patients whose pulmonary blood vessels,

or vessels in the lungs, can accommodate an increase in blood flow during

exercise appear to derive significant benefit from the shunt, compared to those

whose blood vessels can't accommodate the additional flow. While I have long

been an advocate for hemodynamic testing in heart failure, the data from this

study reinforces the importance of exercise phenotyping and will change how we

evaluate heart failure patients and personalize their care."

The REDUCE LAP-HF II trial randomized 626 patients at 89 centers across the US,

Canada, Europe, Australia, and Japan. A systematic, independent, statistical

analysis identified exercise pulmonary vascular resistance (PVR), a measure

indicating the degree of pulmonary vascular disease, and the presence of a

pacemaker as the most significant variables affecting how patients responded to

atrial shunting. The results showed that patients without a pacemaker and with

normal exercise PVR comprised 50% of the total study population and derived

significant clinical benefit:

   -        45% reduction in HF events compared to sham control (12 vs. 22 events

        per 100 patient-years, p=0.007)

   -        55% greater improvement (+5.5 points) in health status as measured    

        by Kansas City Cardiomyopathy Questionnaire (KCCQ), with 40%        

        more shunt patients reporting a very large improvement              

       (Greater than 20 points)in quality of life

   -        50% greater improvement in New York Heart Association (NYHA) HF class,

        indicating fewer HF symptoms

"HFpEF has a complex pathophysiology and remains a significant therapeutic

challenge. While novel drugs are now available, limitations remain, and

additional therapies are required to treat this heterogenous population,"

commented Prof. David Kaye, MD, PhD, Director of the Department of Cardiology

at The Alfred Hospital, Head of Heart Failure Research at the Baker Institute

in Melbourne, Australia, and an investigator in the study." We now know the

importance of exercise hemodynamic phenotyping prior to determining a

therapeutic strategy for HFpEF patients and these learnings should be applied

today in both the commercial and clinical trial settings. Assuming additional

studies confirm the responder population findings, this therapy has enormous

potential to improve the lives of millions of heart failure patients."

REDUCE LAP-HF II represents the largest randomized controlled trial of

device-based therapy for HFpEF patients and is the only study of an implantable

therapeutic device to show clinical benefit in this population. "The Corvia

Atrial Shunt is the most rigorously studied atrial shunt therapy. Exercise

hemodynamic evaluation has been a key component of all our studies and its

importance in identifying suitable patients for atrial shunting has now been

confirmed," commented Jan Komtebedde, Senior Vice President and Chief Medical

Officer at Corvia Medical. "We are working with advisors and regulators to

design a confirmatory study that builds on the extensive data and progressive

learnings from REDUCE LAP-HF II and we look forward to bringing this

breakthrough therapy to the US and international markets to help this

underserved population."

About Corvia Medical, Inc.

Corvia Medical, Inc. is revolutionizing the treatment of heart failure through

novel transcatheter cardiovascular devices. Founded in 2009 and headquartered

in Tewksbury, MA, Corvia is dedicated to transforming the standard of care for

heart failure treatment, enabling patients to reclaim their lives. The Corvia

Atrial Shunt was granted Breakthrough Device designation by the FDA in 2019.

Privately held, the company is backed by Third Rock Ventures, General Catalyst

Partners, AccelMed, Lumira Ventures, Edwards Lifesciences, and an undisclosed

strategic investor. Visit https://corviamedical.com/.

MEDIA CONTACT:

Lisa Ensz

+1 978-654-6120

lensz@corviamedical.com

https://corviamedical.com/newsroom/

    1.        Borlaug BA et al. Latent Pulmonary Vascular Disease May Alter the

        Response to Therapeutic Atrial Shunt Device in Heart Failure.

        Circulation. 2022;10.1161.

    2.        Savarese G, Lund LH. Global Public Health Burden of Heart Failure.  

        Card Fail Rev. 2017;3(1):7-11.

    3.        Owan TE et al. Trends in prevalence and outcome of heart failure    

        with preserved ejection fraction. N Engl J Med. 2006;355:251-259.

SOURCE CORVIA MEDICAL, INC