The pilot study will assess the performance of the Auryon atherectomy system in both intermediate and long-term
The pilot study will assess performance and clinical outcomes of the Auryon atherectomy system (Credit: Pixabay/Gerd Altmann)
AngioDynamics has commenced a pilot study to assess performance and clinical outcomes of the Auryon atherectomy system.
The PATHFINDER I: Post-Market Registry has been launched for the assessment of the safety and efficacy of Auryon atherectomy system to treat de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery diseases (PAD).
The Auryon atherectomy system is a 355nm wavelength laser-technology platform
Earlier known as the Eximo B-Laser, the Auryon atherectomy system is a 355nm wavelength laser-technology platform, which was purchased by the company in October last year.
PATHFINDER I Registry is a prospective, non-randomised, single-arm and multicentre observational trial designed to assess the performance of the Auryon system during procedures and measure clinical outcomes in both intermediate and long-term.
The company will recruit 100 eligible PAD patients to treat with the Auryon atherectomy system in a post-market setting in the study.
AngioDynamics will track the patients for a 36-month period after the initial procedure.
Based on the results of the pilot registry study, the company will launch a large pivotal phase registry, which is expected to recruit around 1,000 patients.
AngioDynamics is also planning to commercially launch the Auryon atherectomy system in the US in the second half of its current fiscal year.
AngioDynamics clinical affairs and healthcare economics vice president Juan Carlos Serna said: “The PATHFINDER I study will provide valuable, scientifically backed data to further differentiate the AURYON system from competitive products in this space and build upon the excellent long-term results that patients experienced during the IDE.”
AngioDynamics provides minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology.
The company’s product portfolio is comprised of ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products.
In October 2019, AngioDynamics acquired Israel-based early commercial-stage medical device company Eximo Medical for $46m up-front consideration.