Abbott's Breakthrough Dissolving Stent Receives FDA Approval for Arteries Below the Knee

Rhea-AI Summary

Abbott has received FDA approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System, a dissolving stent for arteries below the knee. This breakthrough technology provides a new treatment option for people with chronic limb-threatening ischemia (CLTI) and peripheral artery disease (PAD). The system offers better outcomes compared to balloon angioplasty, which was the previous standard of care. The LIFE-BTK trial demonstrated that the Esprit BTK System reduces disease progression and improves medical outcomes. This innovation addresses the significant burden of disease and treatment options for patients with severe PAD.

Positive

• The Esprit BTK System provides a new treatment option for chronic limb-threatening ischemia (CLTI) and peripheral artery disease (PAD.

• The system offers better outcomes compared to traditional balloon angioplasty.

• The LIFE-BTK trial showed that the Esprit BTK System reduces disease progression and improves medical outcomes.

Negative

• Many people in the U.S. are living with peripheral artery disease (PAD) yet only 10% have been diagnosed.

• CLTI has a lower survival rate over a five-year period compared to breast, colorectal, and prostate cancer combined.

• Blockages treated only with balloon angioplasty have poor short- and long-term results.

Medical Device Analyst

Abbott's FDA approval for the Esprit BTK System represents a significant advancement in the treatment of peripheral artery disease (PAD), specifically chronic limb-threatening ischemia (CLTI), which affects a substantial patient population. From a medical device perspective, the introduction of a resorbable scaffold system is a paradigm shift from traditional treatments like balloon angioplasty. The device's ability to both temporarily support the artery and deliver therapeutic agents directly to the vessel wall could set a new standard in CLTI intervention, potentially improving patient outcomes and reducing the need for repeat procedures. This might lead to an increase in demand for Abbott's product, influencing the company’s revenue and market share in the vascular intervention space. Additionally, the successful trial results published in a reputable medical journal add credibility and could catalyze wider adoption among clinicians. Investors should monitor adoption rates post-approval, reimbursement policies and competitive responses to gauge the long-term financial impact.

Healthcare Market Analyst

Abbott's breakthrough in PAD treatment with the Esprit BTK System aligns with a growing demand for advanced vascular therapies. The FDA approval addresses a significant unmet medical need, which could translate into a sizable market opportunity for Abbott. Beyond the clear patient benefit, investors should consider the potential economic implications, such as healthcare cost savings through reduced complications and hospital readmissions. The fact that PAD is underdiagnosed and has a prevalence rate comparable to major cancers indicates a vast market potential as awareness and screening improve. From a strategic standpoint, Abbott’s first-mover advantage in the BTK space could solidify its competitive positioning and potentially act as a springboard for future innovations in the sector. Investors should evaluate the company's capacity to scale production and distribution in line with potential market growth.

Financial Analyst

The FDA approval for Abbott's Esprit BTK System could have a notable financial impact on the company's performance, particularly within its vascular device segment. The approval opens up a new revenue stream that did not previously exist, given the lack of approved stents for BTK interventions. The PAD patient population size and the positive trial outcomes suggest a significant addressable market. However, investors must consider the costs associated with marketing, sales and potentially post-market surveillance studies that may be required. It is also important to analyze how the market reacts to the device in terms of actual utilization versus anticipated adoption, which can affect revenue projections. The long-term profitability will depend on factors such as production scalability, reimbursement rates and competition from other emerging treatments. Tracking quarterly earnings, sales data and management comments in the periods following the launch would provide insights into the financial trajectory related to the Esprit BTK System.

• 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 on LinkedIn, Facebook, Instagram, X and YouTube.

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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

FAQ

What is the Esprit BTK Everolimus Eluting Resorbable Scaffold System?

The Esprit BTK System is a dissolving stent designed to keep arteries open and deliver a drug (Everolimus) below the knee in people with chronic limb-threatening ischemia (CLTI).

What is the standard of care for treating arteries below the knee?

Until the approval of the Esprit BTK System, balloon angioplasty was the standard of care for opening blocked arteries below the knee.

What did the LIFE-BTK trial demonstrate about the Esprit BTK System?

The LIFE-BTK trial showed that the Esprit BTK System reduces disease progression and improves medical outcomes compared to balloon angioplasty.