CVRx announces availability of additional data supporting long-term benefits of Barostim
2024年4月15日 - 8:30PM
CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical
device company, announced today the availability of additional
data, including the publication of results of the post-market phase
of the BeAT-HF trial in the European Journal of Heart Failure.
These data highlight long-term sustained benefits of Barostim in
heart failure patients with reduced ejection fraction.
“Publication of these data from the post-market phase of BeAT-HF
in this prestigious peer-reviewed journal allows for more effective
dissemination of the long-term results of this important trial and
the positive symptomatic impact of Barostim on patients with heart
failure,” said Kevin Hykes, President and CEO of CVRx.
“Additionally, we are pleased at the favorable physician response
to new abstracts released at THT in Boston on March 5, 2024, that
show a reduction in additional heart failure interventions in
patients with Barostim, as well as specific patient-centered
benefits at long-term follow-up.”
The manuscript is available online at the European Journal of
Heart Failure website. CVRx previously announced some of these data
as part of expanded labeling granted by FDA on December 23, 2023.
The key benefits of Barostim contained in the manuscript include
the following:
- There was not a statistically significant difference in the
primary endpoint of CV death and HF hospitalization, demonstrating
that the benefits of the therapy do not increase the long-term risk
of harm to patients
- Patients receiving Barostim + guideline-directed medical
therapy (GDMT) had sustained and significant symptomatic
improvements (6 minute hall walk, quality of life and NYHA class)
at up to 2 years versus those patients receiving GDMT alone
- Patients receiving Barostim + GDMT had a 34% reduced likelihood
of all-cause death or the need for left ventricular assist device
(LVAD) implantation or heart transplant, suggesting a favorable
effect of Barostim therapy
Additionally, two new post-hoc analyses of the BeAT-HF trial
data, presented on March 5, 2024 at Technology in Heart Failure
Therapeutics (THT) 2024 in Boston, suggest additional important
benefits of Barostim.
- Dr. William Abraham of the Ohio State Wexner College of
Medicine presented analysis showing that patients in the trial with
Barostim + GDMT had a 74% reduced risk of receiving advanced heart
failure interventions (transplant, LVAD, CCM, CRT or CardioMEMS) at
long-term follow-up versus patients on GDMT alone. See more details
at TCTMD.
- Dr. JoAnn Lindenfeld of Vanderbilt University presented
analysis showing that patients with Barostim + GDMT had sustained
and significant improvements in quality-of-life scores (MLWHF and
EQ-5D) and many subdomains of these scores (e.g., reductions in
shortness of breath, fatigue, depression and improvements in
self-care, mobility and pain, etc.) versus patients on GDMT alone.
See more details at TCTMD.
“We are grateful to the BeAT-HF executive steering committee and
the many investigators involved in the trial for their dedication
to advancing the science supporting this therapy. We look forward
to the generation of additional evidence about Barostim from the
BeAT-HF trial, as well as from real-world experience through our
REBALANCE post-market registry and investigator-initiated
research,” said Hykes.
About CVRx, Inc.CVRx is focused on the
development and commercialization of the Barostim™ System, the
first medical technology approved by FDA that uses neuromodulation
to improve the symptoms of heart failure. Barostim is an
implantable device that delivers electrical pulses to baroreceptors
located in the wall of the carotid artery. Baroreceptors activate
the body’s baroreflex, which in turn triggers an autonomic response
to the heart. The therapy is designed to restore balance to the
autonomic nervous system and thereby reduce the symptoms of heart
failure. Barostim received the FDA Breakthrough Device designation
and is FDA-approved for use in heart failure patients in the U.S.
It has also received the CE Mark for heart failure and resistant
hypertension in the European Economic Area. To learn more about
Barostim, visit www.cvrx.com.
Media Contact:Laura O’NeillFinn
Partners917.497.2867 laura.oneill@finnpartners.com
Investor Contact:Mark Klausner or Mike
VallieICR Westwicke443.213.0501ir@cvrx.com
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