AngioDynamics (Nasdaq:ANGO) announced today that it enrolled the first patient in a randomized study of its Auryon atherectomy system.
The AMBITION BTK study looks at Auryon in combination with standard balloon angioplasty in treating infrapopliteal lesions in subjects with critical limb ischemia below the knee. It compares this therapy method to standard balloon angioplasty alone.
AMBITION BTK evaluates the clinical safety and effectiveness of Auryon with angioplasty with a primary endpoint evaluated using a win-ratio approach. It compares the two treatment groups based on freedom from major amputation, freedom from clinically driven target lesion revascularization (CD-TLR), and primary patency at 12 months.
AngioDynamics expects the study to include up to 224 patients at up to 30 sites. In parallel, it plans for a companion registry to enroll up to 1,500 additional patients ineligible for the randomized controlled trial.
Dr. Anahita Dua, a vascular surgeon and co-principal investigator, treated the first patient in the trial at Massachusetts General Hospital. Dua says the study allows investigators to collect high-quality, real-world data to evaluate laser technology in BTK disease.
Auryon uses revolutionary solid-state laser technology to treat PAD lesions and occlusions effectively. AngioDynamics describes it as the first laser atherectomy system to efficiently treat lesions of any type, length or location (above and below the knee) with minimal impact on vessel walls.
“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, SVP/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.”
