Two years of echocardiographic data affirm
positive effects of atrial shunt therapy on heart structure and
function
TEWKSBURY, Mass., May 7, 2024
/PRNewswire/ -- Corvia Medical, Inc, a company dedicated to
transforming the treatment of heart failure, today announced the
publication in JAMA Cardiology of two-year echocardiographic data
from its REDUCE LAP-HF II randomized clinical trial of the
Corvia® Atrial Shunt, offering groundbreaking
insight into the impact of a shunt on the heart.
The study demonstrated favorable long-term effects of atrial
shunting on heart structure and function in patients with heart
failure with preserved or mildly reduced ejection fraction
(HFpEF/HFmrEF). Analysis showed that atrial shunting led to
favorable cardiac remodeling, restoration of the heart's normal
function, with resulting improvements in clinical outcome and
prognosis.
The analysis also demonstrated more favorable remodeling in
previously defined responders compared to non-responders,
confirming that patients with no latent pulmonary vascular disease
and no cardiac pacemaker are most likely to benefit from atrial
shunt therapy.
"We now have two-year evidence of reverse remodeling in patients
with an atrial shunt, with more pronounced improvements in cardiac
structure and function — and associated clinical benefit — in
previously defined responders versus non-responders," said
Sanjiv Shah, MD, Director of the
HFpEF Program at Northwestern University
School of Medicine and lead investigator for the
study. "This data not only offers insight into the long-term
effects of atrial shunting but also represents the largest and most
comprehensive echocardiographic follow-up study of any device or
pharmacological trial in HFpEF and HFmrEF to date.
"The findings of our study support the referral of suitable
patients to RESPONDER-HF, a randomized, sham-controlled trial now
underway in the US, Europe and
Australia in pursuit of the
evidence required to achieve FDA approval of the Corvia Atrial
Shunt for millions of heart failure patients."
About heart failure (HF) and the Corvia Atrial Shunt
More than 26 million people worldwide have HF, and the majority
have HFpEF, making it the largest unmet clinical need in
cardiovascular medicine. The Corvia Atrial Shunt is designed to
reduce elevated left atrial pressure (LAP), the primary contributor
to HF symptoms in HFpEF patients, by creating a passage between the
left and right atria, reducing HF events and improving quality of
life. The Corvia Atrial Shunt was granted Breakthrough Device
designation by the FDA in 2019. For information regarding
RESPONDER-HF study eligibility, please visit
https://treatmyheartfailure.com.
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, privately-held Corvia is dedicated to transforming the
standard of care for heart failure treatment, enabling patients to
reclaim their lives. Visit https://corviamedical.com.
MEDIA CONTACT:
Lisa Ensz
+1 978-654-6120
lensz@corviamedical.com
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content:https://www.prnewswire.com/news-releases/newly-published-data-in-jama-cardiology-demonstrates-favorable-long-term-effects-of-the-corvia-atrial-shunt-in-heart-failure-patients-302138893.html
SOURCE Corvia Medical, Inc.