, /PRNewswire/ -- Abbott (NYSE: ) today announced that the U.S. Food and Drug Administration (FDA) has approved the EspritTM 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 kn.
