PR94334

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

REDUCE LAP-HF II study defines treatable HFpEF patient population for atrial

shunt therapy

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

failure (HF), today announced results from its REDUCE LAP-HF II randomized

clinical trial, investigating the safety and efficacy of the Corvia (R) Atrial

Shunt in heart failure patients with preserved (HFpEF) or mildly reduced

(HFmrEF) ejection fraction. While the overall outcome of the trial was neutral,

the data suggests patients with normal exercise pulmonary vascular resistance

(PVR) and without a pacemaker, represent a responder group that derives

significant clinical benefit, making atrial shunting the first implantable

therapy to demonstrate effectiveness in HFpEF. Results were presented today at

the Technology and Heart Failure Therapeutics (THT) 2022 conference and primary

results were published online in The Lancet. Publication of the responder group

analysis is pending.

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"In this first-of-its-kind device trial for a complex and heterogenous type of

heart failure, we have identified a large potential responder population with

meaningful clinical benefit. The ability to predict responders and

non-responders is ground-breaking and has significantly advanced our

understanding of the role of atrial shunting in HFpEF," said Sanjiv Shah, MD,

Professor of Medicine, Director of Research for the Bluhm Cardiovascular

Institute, and Director of the HFpEF Program at Northwestern University

Feinberg School of Medicine and co-principal investigator of the REDUCE LAP-HF

II trial.

The REDUCE LAP-HF II trial is the world's first phase III trial to evaluate an

atrial shunt in heart failure patients to reduce HF symptoms, decrease

HF-related hospitalizations and improve quality of life through a reduction in

left atrial pressure (LAP).  A total of 626 patients were randomized at 89

centers across the US, Canada, Europe, Australia, and Japan. Patients with

normal exercise PVR, indicating the absence of pulmonary vascular disease

(PVD), and without a pacemaker, derived significant clinical benefit, including

a reduction in heart failure events compared to sham (0.12 vs. 0.22 events per

patient-year, p=0.007) and a significant and clinically meaningful difference

in health status improvement over sham (+5.5 points) as assessed by the Kansas

City Cardiomyopathy Questionnaire (KCCQ) overall summary score.1

"Prior to this study, we knew patients with significant PVD would be very

unlikely to benefit from atrial shunt treatment. However, we didn't fully

appreciate the critical role that invasive exercise phenotyping may have in

uncovering the degree of PVD that allows patients to benefit from atrial

shunting," added Barry Borlaug, MD, Professor of Medicine and Director of

Circulatory Failure Research at Mayo Clinic. "While further study is needed,

with appropriate patient selection, atrial shunting may be a great option for

HFpEF patients without any form of PVD. In REDUCE LAP-HF II, treated patients

with normal pulmonary vasculature confirmed through exercise, had a

significantly greater likelihood of clinical benefit than sham control, with a

lower HF event rate and a significant and clinically meaningful KCCQ

improvement."

More than 26 million people in the world have heart failure, (2)  and over half

of those have HFpEF, (3) which has been described as the largest unmet clinical

need in cardiovascular medicine. "These data have important implications not

only for the Corvia Atrial Shunt, but for ongoing and future trials utilizing

atrial shunt devices and procedures to treat heart failure," stated Martin

Leon, MD, Professor of Medicine and Director of Interventional Cardiovascular

Care at Columbia University Irving Medical Center and co-principal investigator

of the REDUCE LAP-HF II trial.

"We are proud that REDUCE LAP-HF II has led us to a major clinical breakthrough

in HFpEF and we are working closely with our clinical advisors and regulators

to expand access to this novel therapy," said Jan Komtebedde, Senior Vice

President and Chief Medical Officer of Corvia Medical. Added George Fazio, CEO

of Corvia Medical, "For the past 12 years, Corvia Medical has been dedicated to

bringing atrial shunting to the millions of heart failure patients who might

benefit, and we are now one giant step closer to making our mission a reality."

About Heart Failure

Heart failure (HF) is a chronic condition that affects approximately 26 million

people worldwide. By 2030, that number will increase by almost 50%, to nearly

38 million people. More than half of all HF patients have HFpEF/HFmrEF, and

that number is increasing, driven by population aging and other risk factors.

In these patients, the proportion of blood pumped out of the heart is normal or

relatively normal, but because the muscles of the left atrium and ventricle are

stiff, the heart cannot relax and fill properly, causing an increase in

pressures in the left heart chambers and the lungs. HFpEF/HFmrEF remains one of

the most significant unmet needs in cardiovascular medicine. While there have

been significant advances in treatment for heart failure with reduced ejection

fraction (HFrEF), there are limited treatment options for HFpEF/HFmrEF.

About the Corvia Atrial Shunt (IASD (R) (TM) )

The Corvia Atrial Shunt is a novel, transcatheter implant for patients

suffering from symptomatic heart failure (HF) and the first therapeutic device

designed to directly address elevated left atrial pressure (LAP), the primary

contributor of HF symptoms. The device (about the size of a dime) is implanted

by an interventional cardiologist or electrophysiologist during a minimally

invasive, outpatient procedure. After a small opening is created in the atrial

septum, the Corvia Atrial Shunt is deployed, forming a passage between the left

and right atria that enables the left atrium to decompress at rest and during

physical activity, with the aim of lowering LAP and pressure in the lungs. By

facilitating continuous and dynamic decompression of the left atrium, the

Corvia Atrial Shunt aims to improve HF symptoms and quality of life, decrease

HF hospitalizations, and reduce the overall cost of managing HF patients. The

Corvia Atrial Shunt is the most clinically studied atrial shunt for the

reduction of LAP in symptomatic HF patients. It was granted Breakthrough Device

designation by the FDA in 2019. The Corvia Atrial Shunt is an investigational

device and is not available for commercial distribution in the United States.

The device is available for sale in the European Union.

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 Medical is dedicated to transforming the standard of

care for heart failure treatment, enabling patients to reclaim their lives.

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

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

strategic investor. For more information, visit https://corviamedical.com/.

MEDIA CONTACT:

Lisa Ensz

+1 978-654-6120

lensz@corviamedical.com

https://corviamedical.com/newsroom/

    1.        REDUCE LAP-HF II 12-Month Primary Endpoint Report Addendum, Baim

        Institute 2022-01-18.

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

        Fail Rev. 2017;3(1):7-11.

    3.        Owan TE, Hodge DO, Herges RM, 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