AngioDynamics Launches Atherectomy System Pilot Study

AngioDynamics Inc., a provider of minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, has announced the launch of the PATHFINDER I: Post-Market Registry (PATHFINDER I-Registry, EX-PAD-05), a pilot study to evaluate the safety and efficacy of the company’s AURYON Atherectomy System in the treatment of de novo, re-stenotic, and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with Peripheral Artery Diseases (PAD).
 
The AURYON Atherectomy System, previously known as the Eximo B-Laser, is a proprietary 355nm wavelength laser-technology platform that was acquired by AngioDynamics in October 2019.
 
“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,” said Juan Carlos Serna, AngioDynamics vice president for Clinical Affairs & Healthcare Economics.
 
AngioDynamics’ PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study that will evaluate the performance of the AURYON Atherectomy System during procedures and measure clinical outcomes, both intermediate and long-term. A total of 100 eligible PAD patients treated with the AURYON Atherectomy System in a post-market setting will be enrolled and tracked for a 36-month period after the initial procedure.
 
Initial findings from the pilot registry study will contribute to a subsequent large pivotal phase registry that is expected to include approximately 1,000 patients. 
 
As previously communicated, the commercial release of the AURYON Atherectomy System in the United States will occur in the second half of AngioDynamics’ current fiscal year. 
 
Net sales for the second quarter of fiscal 2020, which now include the fiscal year 2019 acquisitions of BioSentry and RadiaDyne as organic revenue, were $70 million, flat compared to the prior-year quarter. Excluding the impact of Asclera sales, which were discontinued during fiscal year 2019, net sales grew 2.5 percent year over year. Foreign currency translation did not have a significant impact on the company’s sales in the quarter.
 
Oncology net sales were $16.1 million, an increase of 5.1 percent from $15.3 million a year ago, led by higher sales of NanoKnife and the Alatus and IsoLoc balloon products.
 
Vascular Interventions and Therapies (VIT) net sales were $31.2 million, an increase of 0.6 percent, compared to $31 million a year ago. Excluding last year’s Asclera sales of $1.7 million in the second quarter, VIT grew 6.5 percent, driven by growth in sales of the company’s AngioVac and core VIT products.
 
Vascular Access net sales were $22.8 million, a decrease of 4 percent from $23.7 million a year ago, due primarily to lower sales of Ports and PICCs.