Tuesday, April 30, 2024
Abbott has just announced that the U.S. Food and Drug Administration (FDA) has given the green light to the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (Esprit BTK System), a groundbreaking solution for individuals dealing with chronic limb-threatening ischemia (CLTI) below the knee (BTK). This approval marks a significant advancement in addressing the challenges faced by patients with this condition.
Before today, there were no stents or drug-coated balloons sanctioned for use below the knee in the U.S. The standard treatment has been balloon angioplasty, a procedure where a small balloon is inserted through a catheter to the blockage, compressing it against the arterial wall to restore blood flow. However, outcomes with this method have often been suboptimal, with blockages recurring frequently, necessitating further intervention.
The Esprit BTK System represents a pioneering approach as the first dissolvable stent of its kind, made from materials akin to dissolving sutures. Implanted during a minimally invasive catheter-based procedure via a small leg incision, the device aids in healing the vessel and provides structural support for approximately three years until the vessel strengthens sufficiently to maintain patency independently.
"The FDA's approval of Abbott's Esprit BTK System signifies a significant leap forward in our battle against peripheral artery disease below the knee and promises improved outcomes for individuals globally”. By introducing a treatment option superior to balloon angioplasty, Abbott is reshaping the landscape of CLTI therapy."
The LIFE-BTK trial, which investigated Abbott's Esprit BTK System, showcased promising results, demonstrating a reduction in disease progression and enhanced medical outcomes compared to standard balloon angioplasty.
Peripheral artery disease (PAD) is a prevalent yet often overlooked condition, affecting over 20 million individuals in the U.S., with CLTI representing its severe manifestation.
Despite its severity, CLTI remains underdiagnosed, leading to profound consequences such as excruciating pain, non-healing wounds, and potential limb amputation. Over five years, CLTI has a lower survival rate than breast, colorectal, and prostate cancer combined, emphasizing the urgent need for effective interventions.
Emphasized the company's commitment to addressing the significant disease burden and unmet needs in PAD treatment.
Revolutionizing treatments with resorbable scaffold technology below the knee, aiming to enhance the quality of life for individuals living with this debilitating condition.
Source: prnewswire.com
