AtheroMed announced that it has completed patient enrolment in the EASE clinical study. The EASE study results were presented by Stephen Williams, director, Vascular Medicine Center at Johns Hopkins University, Baltimore, USA, during a Late Breaking Clinical Trials Session 9 October, at the Vascular Interventional Advances (VIVA) conference in Las Vegas, USA.
The EASE study was a prospective, multicentre, single-arm study to evaluate the safety and effectiveness of the Phoenix Atherectomy System for the treatment of de novo and restenotic lesions of lower extremity arteries. The study was conducted under an investigational device exemption (IDE) to support US Food and Drug Administration (FDA) clearance and enrolled 105 patients at 16 sites in the USA and Germany.
Outcome assessments were made after the baseline procedure and at 30-day and six-month follow-up visits. Co-principal investigators of the study were Thomas Davis, St John Hospital (Detroit, USA), and James McKinsey, Columbia Presbyterian Hospital (New York, USA).
“Peripheral arterial disease, especially blockages located below the knee, continues to present challenges, even with currently available technologies,” said Davis. “Based on my case results in the EASE study, the Phoenix Atherectomy System appears promising as a front-line therapy for treating peripheral arterial disease.”