- More than 20 million people in the U.S. are living with
peripheral artery disease (PAD) yet there have been limited
treatment options
- The first-of-its-kind Esprit™ BTK Everolimus Eluting Resorbable
Scaffold dissolves over time after it has opened blocked arteries
below the knee (BTK)
- The Esprit BTK System is a dissolving stent that offers the
possibility of better outcomes for people with the most severe form
of PAD
ABBOTT
PARK, Ill., April 29,
2024 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced that the U.S. Food and Drug Administration (FDA) has
approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold
System (Esprit BTK System), a breakthrough innovation for people
with chronic limb-threatening ischemia (CLTI) below-the-knee (BTK).
The Esprit BTK System is designed to keep arteries open and deliver
a drug (Everolimus) to support vessel healing prior to completely
dissolving.
Until today, there were no stents or drug-coated balloons
approved for use below the knee in the U.S. The standard of care
has been balloon angioplasty, which relies on a small balloon
delivered via a catheter to the blockage to compress it against the
arterial wall, opening the vessel and restoring blood flow.
However, blockages treated only with balloon angioplasty have poor
short- and long-term results, and in many instances the vessels
become blocked again, requiring additional treatment.
The Esprit BTK System is a first-of-its-kind dissolvable stent
and is comprised of material similar to dissolving sutures. The
device is implanted during a catheter-based minimally invasive
procedure via a small incision in the leg. Once the blockage is
open, the Esprit BTK scaffold helps heal the vessel and provides
support for approximately three years until the vessel is strong
enough to remain open on its own.
"The FDA approval of Abbott's Esprit BTK System marks a
significant milestone in our fight against peripheral artery
disease below the knee and should usher in a new era of
improved outcomes for people worldwide," said Sahil
A. Parikh, M.D., Columbia University Irving Medical
Center, and one of the principal investigators of the LIFE-BTK
trial. "By introducing a treatment option that is superior to
balloon angioplasty, Abbott is changing the landscape
of CLTI therapy."
The LIFE-BTK trial, which evaluated Abbott's Esprit BTK
System, was presented in October
2023 as a late-breaking clinical trial at the 35th
Transcatheter Cardiovascular Therapeutics (TCT) Conference in
San Francisco and simultaneously
published in the New England Journal of Medicine. The
results of the trial demonstrated that the Esprit BTK System
reduces disease progression and helps improve medical outcomes
compared to balloon angioplasty, the current standard of care.
PAD is highly prevalent, yet many people have never heard
of the condition. More than 20 million people in the U.S. are
living with this painful disease and only 10% of those people have
been diagnosed.1,2 CLTI is a serious form of PAD
that occurs when arteries become clogged with plaque, preventing
blood flow and oxygen from reaching the lower leg and foot. People
living with CLTI often experience extreme pain, open wounds that
don't heal and, in some cases, may have to resort to amputation.
Over a five-year period, CLTI has a lower survival rate than
breast, colorectal and prostate cancer combined.3
"At Abbott, we've recognized the significant burden of disease
and limited treatment options available for people living with the
most severe form of PAD. That's why we're revolutionizing
treatments with resorbable scaffold technology below the knee,"
said Julie Tyler, senior vice
president of Abbott's vascular business. "Our resorbable program is
focused on meeting unmet needs in the peripheral anatomy to help
people live better and fuller lives."
As part of Abbott's continued commitment to helping all people
live healthier lives, PAD and CLTI education information can
be found at www.PAD-info.com. Physicians can find more information
at www.CLEAR.abbott.
For U.S. important safety information on Esprit BTK System,
visit:
https://www.cardiovascular.abbott/us/en/hcp/products/peripheral-intervention/esprit-btk-resorbable-scaffold-system/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 114,000 colleagues serve people in more than 160
countries.
Connect with us at www.abbott.com and
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1 Fowkes, F.G., et al., Comparison of global
estimates of prevalence and risk factors for peripheral artery
disease in 2000 and 2010: a systematic review and analysis. Lancet,
2013. 382(9901): p. 1329-40–––.
2 Nehler, M.R., et al., Epidemiology of peripheral
arterial disease and critical limb ischemia in an insured national
population. J Vasc Surg, 2014. 60(3): p. 686-95 e2.
3 Li J, Varcoe R, Manzi M, Kum S, Iida O, Schmidt A,
Shishehbor MH. Below-the-Knee Endovascular Revascularization: A
Position Statement. JACC: Cardiovascular Interventions.
2024; ISSN 1936-8798
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SOURCE Abbott