ABBOTT PARK, Ill., Feb. 21, 2022
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S.
Food and Drug Administration (FDA) has approved an expanded
indication for the company's CardioMEMS™ HF System to support the
care of more people living with heart failure. With the expanded
indication, an additional 1.2 million U.S. patients1 are
now eligible to benefit from advanced monitoring with the
CardioMEMS sensor, which marks a significant increase over the
current addressable population. The sensor provides an early
warning system enabling doctors to protect against worsening heart
failure.
Experience the interactive Multimedia News Release
here:
https://www.multivu.com/players/English/9015451-abbott-cardiomems-hf-system-fda-approval/
More than 6.2 million Americans have heart failure2,
with diagnoses projected to double3 by 2030. While heart
failure is a chronic disease, medical options like CardioMEMS can
provide patients and their doctors with actionable insights to help
manage heart failure before it progresses to a later stage. The
CardioMEMS sensor is a paperclip-sized device that, once placed in
the pulmonary artery during a minimally invasive procedure,
monitors for pressure changes that indicate worsening heart
failure. The sensor wirelessly transmits daily pressure readings to
a patient's clinical team – allowing physicians to make therapy
changes to combat progression to later-stage heart failure while
empowering the patient to manage their condition from virtually
anywhere.
The CardioMEMS HF System was initially approved in 2014 for use
in New York Heart Association (NYHA) Class III heart failure
patients with a prior heart failure hospitalization within the last
year. The new indication allows the CardioMEMS sensor to be used by
people living with Class II heart failure and for patients who
undergo a blood test showing elevated levels of biomarkers known as
natriuretic peptides, which indicate worsening heart failure.
"Heart failure is a race against time where too often we're
behind because patients are not getting care early enough," said
Philip B. Adamson, M.D., chief
medical officer of Abbott's heart failure business. "This expanded
indication means physicians can treat more people with
earlier-stage heart failure, providing the opportunity to prevent
further suffering and possibly avoid later-stage progression that
can have a profound impact on a person's quality of life."
Clinical Data Reveals Benefits of Remote Monitoring
The CardioMEMS HF System's expanded indication was supported by
clinical data from the GUIDE-HF trial. Based on study data adjusted
for the impact of COVID-19, both Class II heart failure patients
and patients with elevated natriuretic peptides were suggested to
have better outcomes when their therapy was guided by pulmonary
pressure monitoring, with a respective 34% and 25% reduction in
heart failure hospitalizations, emergency visits and death.
Class II heart failure is generally categorized as mild heart
failure where patients have a slight limitation with physical
activity. Patients in Class II heart failure may feel comfortable
at rest but routine physical activity, such as getting the mail,
can cause fatigue or shortness of breath. Since the disease can
advance to Class III and IV heart failure if left untreated, it's
critical for earlier-stage patients to explore the most effective
medical options to manage the disease at its onset.
"As the number one cause for hospitalizations in people age 65
and over, heart failure is its own pandemic in the United States," said J. Thomas Heywood, M.D., director of Advanced Heart
Failure and co-director of the Pulmonary Hypertension Program at
Scripps Clinic in La Jolla, Calif.
"Utilizing the CardioMEMS HF System to monitor for signs of
worsening heart failure has been shown repeatedly to reduce
hospitalizations for patients with later-stage heart disease. The
new data provided by the GUIDE-HF study means we can extend these
benefits to less sick patients. In the
United States alone, this could have a positive impact for
more than a million people suffering from heart failure."
Actionable Insights Lead to an Active Life
Robert (Bob) Birdwell, D.D.S., a
retired dentist, enjoyed an active lifestyle before being diagnosed
with heart failure. He had difficulty controlling his high blood
pressure and felt drained walking to the mailbox. In 2020, Bob
received CardioMEMS as a GUIDE-HF trial participant.
"In dentistry, we live in the preventative world of maintaining
good oral health. The same concept applies to heart disease where
my CardioMEMS is a preventative measure," said Bob. "I have not had
a heart failure-related hospitalization since receiving it. I feel
grateful."
Nearly two years later, Bob and his wife Vinnie are back to
playing golf and exploring their Colorado community. For more on his story,
click here.
About the GUIDE-HF Clinical Trial
The GUIDE-HF study included a randomized arm of 1,000 patients and
a single arm of up to an additional 2,600 patients that is
currently enrolling for a total of 3,600 patients across 118
centers in North America. All patients were implanted with a
CardioMEMS sensor, but therapy for patients in the control arm was
not guided by the device. In an analysis of data adjusted for the
impact of COVID-19 (captured prior to March 13, 2020 –
the date the U.S. national emergency was declared), CardioMEMS
demonstrated a significant 19% reduction in the study's composite
endpoint and a 28% reduction in heart failure hospitalizations. The
results of GUIDE-HF were presented at the ESC Congress 2021
(organized by the European Society of Cardiology) in August 2021 and simultaneously published in
The Lancet.
Indications and Important Safety Information:
For U.S. important safety information for the CardioMEMS HF System,
visit:
https://www.cardiovascular.abbott/us/en/patients/treatments-therapies/pulmonary-artery-pressure-monitoring-for-heart-failure/important-safety-information.html.
About Abbott:
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 113,000 colleagues
serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
1 Abbott Heart Failure Navigant Data 2021
2 Centers for Disease Control and Prevention. Facts
About Heart Failure in the United
States. Heart Failure | cdc.gov. Accessed Dec. 30, 2021.
3 American Heart Association. Heart Failure Projected
to Increase Dramatically, According to New Statistics. Heart
failure projected to increase dramatically, according to new
statistics | American Heart Association. Accessed Dec. 30, 2021.
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SOURCE Abbott