Business
AngioDynamics Initiates AMBITION BTK RCT and Registry to Advance Treatment for Critical Limb Ischemia
Trial Evaluates Effectiveness of Innovative Auryon Atherectomy System in Complex Below-the-Knee Cases LATHAM, N.Y.--(BUSINESS WIRE)-- AngioDynamics, Inc.
About this update from Angiodynamics, Inc.
[{"type":"text","content":"\nTrial Evaluates Effectiveness of Innovative Auryon Atherectomy System in Complex Below-the-Knee Cases\n\n\n LATHAM, N.Y.--(BUSINESS WIRE)--\nAngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving patient quality of life, today announced the start of a Randomized Study of the Auryon Atherectomy System Used in Combination with Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone Treating Infrapopliteal Lesions in Subjects with Critical Limb Ischemia Below-the-Knee (AMBITION BTK).\n\n\nAMBITION BTK is a multicenter, randomized controlled trial (RCT) designed to evaluate the clinical outcomes of the Auryon Atherectomy System in combination with standard balloon angioplasty compared to standard balloon angioplasty alone for the treatment of infrapopliteal lesions in patients with critical limb ischemia. The trial will enroll up to 200 subjects across up to 30 hospital-based sites. Additionally, up to 1,500 subjects treated with the Auryon Atherectomy System at the same sites who do not meet the eligibility criteria of the RCT will be enrolled in a companion Registry.\n\n\nLower extremity peripheral artery disease (PAD) affects more than 230 million adults worldwide and is associated with an increased risk of various adverse clinical outcomes.1 In its most severe form, critical limb ischemia patients are often treated with lower extremity amputation (LEA).2\n\n\n“We are dedicated to expanding innovative treatment options for peripheral artery disease, particularly in challenging cases like below-the-knee lesions,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. “The AMBITION BTK RCT and Registry represents an important advancement in evaluating the clinical benefits of the Auryon Atherectomy System. Physicians have expressed strong interest in the platform's unique capabilities, and we are eager to demonstrate further its potential to improve outcomes for patients with critical limb ischemia.”\n\n\nThe Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK) and In-Stent Restenosis (ISR)3,4,5,6 and to date, it has been used to treat more than 100,000 pa...