August 17, 2020
Postmarket PATHFINDER I Registry Commences for AngioDynamics’ Auryon Atherectomy System
August 17, 2020—AngioDynamics, Inc. announced the enrollment of the first patient in the postmarket PATHFINDER I registry, which is a pilot study designed to evaluate the safety and efficacy of the company’s Auryon atherectomy system in the real-world treatment of de novo, restenotic, and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD).
According to AngioDynamics, the registry is structured as a prospective, nonrandomized, single-arm, multicenter observational study that will evaluate the performance of the Auryon system during procedures and measure intermediate and long-term clinical outcomes.
Ten centers in Texas, Iowa, Arizona, New Jersey, and Florida are expected to participate in the PATHFINDER I registry, enrolling 100 eligible patients with PAD and tracking outcomes for 24 months after treatment with the Auryon system. The company first announced the plans for the PATHFINDER I registry in January 2020.
Initial findings from this pilot registry study will inform and help shape a subsequent larger registry that is expected to include approximately 1,000 patients, advised the company.
Jason Yoho, MD, of the Heart and Vascular Institute of Texas, which is based in San Antonio, Texas, enrolled the first patient in the PATHFINDER I registry. The patient is a 61-year old woman with a medical history of atrial fibrillation, hypertension, hyperlipidemia, and previous myocardial infarction. She was initially evaluated for severe claudication at rest and was classified as Rutherford 5. A diagnostic angiography of her right leg revealed severely calcified and diseased anterior and posterior tibial arteries.
“Thanks to the successful Auryon laser atherectomy procedure, which was performed in conjunction with balloon angioplasty, there is now excellent rapid flow restored into the pedal arch,” commented Dr. Yoho in the company's announcement. “In this case of severely calcified and tortuous anatomy, other devices likely would not have been as successful.
“Having a passion for critical limb ischemia and limb salvage, my staff and I are eager to advance the body of knowledge around the Auryon atherectomy system through the PATHFINDER I registry. I am excited that AngioDynamics is dedicated to improving upon existing atherectomy technology and increasing the quality of care in the peripheral space. It is critical that we aggressively seek out and support promising new technologies, such as the Auryon system, so that we can provide patients with the best outcomes possible.”
AngioDynamics stated that the Auryon system is a laser technology platform that is FDA-indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including ISR. The Auryon system uses a 355-nm wavelength laser platform that enables the use of longer wavelengths and shorter pulses to produce delivery of short ultraviolet laser pulses.
In October 2019, AngioDynamics acquired Eximo Medical, Ltd., the early commercial-stage medical device company that developed the Auryon system, previously known as the Eximo B-Laser.