AngioDynamics Auryon system to be studied in BTK arteries
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 Sep. 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.” VTN