AngioDynamics, Inc. a MedTech company focused on restoring healthy blood flow, improving cancer care, and enhancing quality of life, has enrolled the first patient in its AMBITION BTK trial. This randomized, multicenter controlled trial is evaluating the Auryon Atherectomy System used in combination with standard balloon angioplasty versus angioplasty alone for treating infrapopliteal lesions in patients diagnosed with critical limb ischemia (CLI). The study will include up to 224 patients across 30 sites, while a companion registry will track up to 1,500 patients ineligible for the main trial but treated with the Auryon system either above or below the knee.

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Laura Piccinini, Senior Vice President and General Manager of Cardiovascular & International at AngioDynamics, said, “The first patient being enrolled in the AMBITION BTK trial is a key step in our effort to build stronger clinical evidence for treating below-the-knee peripheral artery disease (PAD).” CLI represents a severe condition, with a risk of major limb amputation in 20 to 25 percent of patients within one year if left untreated. Infrapopliteal disease is particularly prevalent, affecting more than 70 percent of CLI cases, especially in individuals with diabetes. The trial’s primary goal is to evaluate outcomes at 12 months, including freedom from major amputation, the need for repeat treatment at the target lesion, and continued vessel patency, assessed in a specific order using a win-ratio approach.

Dr. Ehrin Armstrong, MD, MSc, FACC, FSCAI, FSVM, Co-Principal Investigator of the AMBITION BTK trial and interventional cardiologist at the Advanced Heart and Vein Center, emphasized the significance of the study, stating, “The Auryon laser can help restore normal blood flow and has the potential to greatly improve outcomes for this difficult group of patients.” The laser’s ability to re-establish laminar flow may address limitations seen in current below-the-knee interventions that rely heavily on balloon angioplasty alone.

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The first patient procedure was performed by Dr. Anahita Dua, MD, MS, MBA, FACS, a vascular surgeon at Massachusetts General Hospital and associate professor of surgery at Harvard Medical School. She said, “I am excited to perform the first case in the AMBITION BTK study. People with below-the-knee disease often have few treatment options and poor long-term results. Globally, there has been a big rise in people with below-the-knee disease, which is sadly leading to a growing number of amputations. Having new tools and methods to restore blood flow to the foot, allowing wounds to heal, and helping patients keep their limbs and lives is very important, and this trial focuses on that.” The Auryon Atherectomy System, a solid-state laser platform, is FDA-cleared for use in treating infrainguinal vascular blockages, including in-stent restenosis, and is designed to minimize trauma while effectively clearing vessel obstructions.

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