US-based medical device manufacturer AngioDynamics has announced the launch of PATHFINDER I: Post-Market Registry, a study to assess performance and clinical outcomes of the Auryon atherectomy system.
The Auryon atherectomy system is intended to treat de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with Peripheral Artery Diseases (PAD).
It is a prospective, non-randomised, single-arm and multicentre observational trial which will assess the performance of the system during procedures and measure clinical outcomes, in intermediate and long-terms.
The Auryon atherectomy system, Eximo B-Laser, is a 355nm wavelength laser-technology platform, which was acquired by the company in October.
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.”
For the study, AngioDynamics will enrol 100 eligible PAD patients treated with the Auryon atherectomy system in a post-market setting. The company will track the condition of the patients for 36 months after the initial procedure.
Based on the results of the pilot registry study, the US-based firm will launch a more extensive study, which will include nearly 1,000 patients.
The commercial launch of the Auryon Atherectomy System is expected to take place in the second half of the company’s current fiscal year.
In October, AngioDynamics acquired medical device firm Eximo Medical and its laser technology for the treatment of peripheral artery disease (PAD).