AngioDynamics Enrolls First Patient in Trial for Treating Critical Limb Ischemia

July 28, 2025 — AngioDynamics, Inc. has announced enrollment of the first patient in the 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).

AMBITION BTK is a prospective, multicenter, randomized controlled trial (RCT) designed to investigate the clinical safety and effectiveness of the Auryon Atherectomy System combined with standard balloon angioplasty, compared to balloon angioplasty alone, in treating infrapopliteal lesions in patients with Critical Limb Ischemia (CLI). The primary endpoint will be evaluated using a win-ratio approach, comparing the two treatment groups based on the following components in a hierarchical manner at 12 months: freedom from major amputation, freedom from clinically driven target lesion revascularization (CD-TLR), and primary patency.

The RCT will include up to 224 patients at up to 30 sites. In parallel, a companion registry will enroll up to 1,500 additional patients who are ineligible for the RCT and are treated with the Auryon System above or below the knee.

“The enrollment of the first patient in the AMBITION BTK trial is a significant milestone in our commitment to advancing clinical evidence for the treatment of below-the-knee peripheral artery disease (PAD),” said Laura Piccinini, Senior Vice President/General Manager, Cardiovascular & International, AngioDynamics. “There is a pressing need for new treatment strategies to help patients suffering from chronic limb ischemia, and we are proud to partner with clinicians to evaluate the Auryon System in this important setting.”

The overall risk of limb loss in CLI is estimated at 20–25% at one year if left untreated, reflecting a large impact on quality of life and healthcare costs.¹ Incidence of infrapopliteal disease in patients with CLI, particularly in the diabetic population, is estimated to be >70%.²

“Treatment options for below-the-knee lesions are still limited and often depend heavily on balloon angioplasty,” said AMBITION BTK Co-Principal Investigator Ehrin Armstrong, FACC, FSCAI, FSVM, MD, MSc, Interventional Cardiologist and Vascular Disease, Director of Clinical Research, Advanced Heart and Vein Center. “The Auryon laser can restore laminar flow and therefore has the potential to improve outcomes in this challenging patient population significantly.”

The first patient in the trial was treated by Anahita Dua, MD, MS, MBA, FACS, a vascular surgeon at Massachusetts General Hospital and associate professor of Surgery at Harvard Medical School, and Co-Principal Investigator of AMBITION BTK.

“I’m excited to perform the first patient case in the AMBITION BTK study. Patients with below-the-knee disease often face limited treatment options and poor long-term outcomes,” said Dr. Dua. “Across the world, there has been a significant increase in patients with below-the-knee (BTK) disease, which is, unfortunately, resulting in an amputation epidemic. Having new tools and techniques to restore blood flow to the foot, allowing wounds to heal, and patients to preserve both their limbs and lives, is critically important and the focus of this trial. This trial will allow us to collect high-quality, real-world data using a robust research design, helping us truly evaluate the impact of laser technology in BTK disease.”

The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), BTK, and In-Stent Restenosis (ISR)^3,4,5,6 and, to date, it has been used to treat more than 100,000 patients in the United States and worldwide.⁷

Visit www.angiodynamics.com/studies/ambition-btk/ and clinicaltrials.gov/study/NCT06777901 for more information.