AngioDynamics Enrolls 1st Patient in Auryon Atherectomy System Study

AngioDynamics has enrolled the first patient in its study of 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).

The Auryon laser is used to treat all infrainguinal lesion types, including above-the-knee (ATK), BTK, and In-Stent Restenosis (ISR). TO date, it’s been used to treat over 100,000 patients in the U.S. and worldwide, the company said.

The prospective, multicenter, randomized controlled trial (RCT) will investigate the safety and effectiveness of the Auryon atherectomy system with standard balloon angioplasty, compared to balloon angioplasty alone, to treat infrapopliteal lesions in patients with critical limb ischemia (CLI). The primary endpoint will be assessed using a win-ratio approach, comparing the two treatment groups at 12 months on freedom from major amputation, freedom from clinically driven target lesion revascularization (CD-TLR), and primary patency.

The trial will enroll 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 Auryon above or below the knee.

“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 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),” added Laura Piccinini, Senior VP/GM, 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.”

Earlier this month, the company enrolled the first patient in a prospective, multi-center study evaluating the efficacy of its AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System in treating acute, intermediate-risk pulmonary embolism (PE).