AngioDynamics Auryon Atherectomy System to Be Studied in BTK Arteries

April 14, 2022—AngioDynamics, Inc. announced the launch of a new clinical study assessing the use of the company’s Auryon atherectomy system in the treatment of calcified lesions in below-the-knee (BTK) arteries. The company announced the commercial launch of the Auryon system in September 2020.

The investigator-initiated Auryon BTK study will be conducted by the Midwest Cardiovascular Research Foundation in Davenport, Iowa, under the guidance of Principal Investigator Nicolas Shammas, MD. Dr. Shammas is Founder and Research Director of the Midwest Cardiovascular Research Foundation.

According to the company, the prospective, multicenter, single-arm study will evaluate the safety and procedural effectiveness of the Auryon system in treating infrapopliteal disease in patients with critical limb ischemia (CLI; Rutherford 4 and 5). The study will enroll 60 patients and be conducted at up to four sites in the United States. Patients will be assessed at 30 days and 3, 6, and 12 months posttreatment.

The primary safety endpoint is defined as a composite of major adverse limb events and postoperative death at 30 days.

The primary performance endpoint is procedural success, defined as ≤ 30% residual stenosis for the treated vessel segment without serious angiographic complications after final treatment. This will be adjudicated via angiographic core lab. Secondary endpoints include primary patency at 6 and 12 months and clinically driven target lesion revascularization at 30 days and 3, 6, and 12 months.

“The Auryon laser is uniquely suited to treat tibial vessels in limb ischemia patients all the way into the pedals,” commented Dr. Shammas in AngioDynamics’ press release. “It has been shown to treat all types of plaque morphology, including severe calcium, and demonstrated excellent luminal area gain following adjunctive balloon angioplasty, with a low incidence of flow-limiting dissections and need for bailout stenting.”

Dr. Shammas continued, “The multicenter prospective Auryon system BTK study will evaluate procedural and technical success and the need for bailout stenting posttreatment in the tibial vessels and determine the presence and depth of dissections using intravascular ultrasound. Sparing the deeper layers of the vessel wall while obtaining optimal luminal gain may yield good patency and freedom from target lesion revascularization at 1-year follow-up.”

Study investigator Warren Swee, MD, Chief Medical Officer of Palm Vascular Centers in Hollywood, Florida, added, “We are very excited to start enrolling in the Auryon system BTK study. This study will further investigate the role of laser atherectomy using a 355-nm wavelength short-pulse laser in the tibial arteries of CLI patients. The small size of these vessels with long-segment and heavily calcified disease has been a challenge to treat with other atherectomy devices. We are interested to see if the Auryon laser will fare better given its low profile and early data suggesting the ability to effectively treat a variety of plaque types.”