FDA approves Limflow System in patients with chronic limb - threating ischemia
LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced that the FDA has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation
The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is designed to reestablish blood flow in deep veins for “no-option” CLTI patients. The therapy is designed to save patients’ legs from major amputation, as limb loss is associated with significant complications, mortality, and deterioration of quality of life. CLTI affects up to four million Americans and disproportionately impacts minority and underserved patients, resulting in more than 150,000 major amputations per year in the U.S. FDA approval of the LimFlow System will enable these patients to have access to a minimally invasive treatment giving them a chance to save their limbs and improve their quality of life.