- Abbott's new investigational drug-eluting Esprit BTK
(below-the-knee) resorbable scaffold is made of naturally
dissolving material that disappears over time after it's opened a
clogged artery
- There is a significant need for more treatments: there are
currently no drug-eluting stents, drug-coated balloons or
bare-metal stents approved for below the knee (BTK) use in the
U.S.
- Abbott's landmark LIFE-BTK randomized clinical trial met its
primary safety and effectiveness endpoints, demonstrating that
Esprit BTK offers significant advancements in opening and keeping
blocked arteries below-the-knee open compared to the standard of
care, balloon angioplasty
SAN
FRANCISCO, Oct. 25, 2023 /PRNewswire/ -- Abbott
(NYSE: ABT) today announced late-breaking data from the LIFE-BTK
clinical trial evaluating the Esprit™ BTK Everolimus Eluting
Resorbable Scaffold System (Esprit BTK) in people with chronic
limb-threatening ischemia (CLTI). CLTI is a severe stage of
peripheral artery disease (PAD) due to advanced arterial blockage
in the lower extremities. The LIFE-BTK trial met both of its
primary safety and effectiveness endpoints, demonstrating that
Esprit BTK reduces disease progression and helps improve medical
outcomes compared to the current standard of care, balloon
angioplasty.
Data from LIFE-BTK was presented 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.
"Millions of people suffer from PAD. Yet, in the United States, there are currently no
approved drug-eluting stents, drug-coated balloons or bare-metal
stents available for use below-the-knee," said Brian DeRubertis, MD, FACS, New York
Presbyterian-Weill Cornell Medical Center, and one of the principal
investigators in the trial. "This underscores a pressing and
substantial need for improved treatment options for people with
CLTI and PAD. Results from the LIFE-BTK trial highlight the
efficacy of Esprit BTK and its potential to deliver significant
benefits in terms of opening blocked arteries below-the-knee and
providing sustained treatment over time."
More than 200 million people worldwide have PAD with nearly 11%
affected by CLTI1,2, a severe form of PAD. In these
people, blocked vessels impair blood flow to the lower extremities,
often leading to severe pain, non-healing wounds, and, in some
cases, the need for limb amputation. Balloon angioplasty, a
procedure in which a small balloon is inserted into the artery to
open the blockage, is currently one of the approved procedures for
people in the U.S. with CLTI. However, in many instances, the
vessels become blocked again over time following balloon
angioplasty, requiring additional treatment.
Abbott's Esprit BTK is a drug-eluting resorbable scaffold
comprised of materials similar to dissolving sutures. Unlike metal
stents, Esprit BTK is not a permanent implant, as blocked vessels
only need support for a few months after the blockage is cleared.
At that point, the vessel can stay open on its own, which is why
Esprit BTK is designed to serve a temporary, yet crucial role.
The LIFE-BTK trial enrolled 261 people worldwide. The study
aimed to investigate whether Esprit BTK could offer greater
benefits than the current option of balloon angioplasty to open
blocked arteries in the leg and to keep the arteries open. The
trial's primary efficacy endpoint evaluated primary patency plus
limb salvage (the ability of the vessel to stay open, and
increasing the time until another intervention is needed). The
trial met the efficacy endpoint and showed that Esprit BTK is
superior to balloon angioplasty in lowering the risk of total
obstruction of the target vessel, narrowing of the target lesion,
major amputation and repeat interventions of the target lesion. The
primary safety endpoint evaluating freedom from above-the-ankle
amputation, major reintervention at six-months and death within
30-days showed that Esprit BTK was non-inferior (similar
performance) to balloon angioplasty.
Results of the one-year LIFE-BTK clinical trial
showed:
- Esprit BTK had a significantly greater freedom from the primary
efficacy clinical events of 74.5 vs 43.7% (balloon angioplasty) for
people with CLTI.
- The trial's powered secondary endpoints revealed that Esprit
BTK was superior to balloon angioplasty at reducing vessel
re-narrowing (25.8% improvement) and sustaining openness of the
vessels (14.2% improvement).
"The LIFE-BTK trial data underscores the profound impact that
Esprit BTK could have for millions with PAD," said Jennifer Jones-McMeans, divisional vice
president of global clinical affairs at Abbott's vascular business.
"With angioplasty, multiple interventions are all too common. The
results from this trial demonstrate a compelling and meaningful
development in clinical outcomes, ultimately helping people have
less adverse events and reinterventions, enhancing their quality of
life."
Based on the strength of the LIFE-BTK trial results, Abbott
intends to submit the Esprit BTK Everolimus Eluting Resorbable
Scaffold System for review by the U.S. Food and Drug Administration
(FDA).
CAUTION: Investigational device. Limited by Federal
(U.S.) law to investigational use only.
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 115,000 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.
1Fowkes, 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.
2Nehler, 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.
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SOURCE Abbott