EASE Study Data Presented on AtheroMed's Phoenix Atherectomy System

October 10, 2013—The EASE study data were presented by Steve Williams, MD, at a late-breaking trial session during the VIVA 2013: Vascular Interventional Advances conference, being held October 8–11 in Las Vegas, Nevada.

Dr. Williams noted that AtheroMed, Inc. (Menlo Park, CA) recently completed the EASE (Endovascular Atherectomy Safety and Effectiveness) study, which is a prospective, multicenter, single-arm evaluation in the United States and Germany. The EASE study was designed to evaluate the safety and effectiveness of the company's Phoenix atherectomy system in the treatment of de novo and restenotic lesions of lower extremity arteries. The study was conducted under an investigational device exemption to support US Food and Drug Administration clearance. The AtheroMed Phoenix atherectomy system is a novel device that uses a front-cutting, low-profile design to continuously cut, capture, and clear atheroma from the patient without requiring specialized capital equipment.

According to Dr. Williams, the study enrolled 105 patients across 16 sites from August 10, 2010, through April 2, 2013. Outcome assessments were made after the baseline procedure and at 30-day and 6-month follow-up visits. National Co-Principal Investigators were Thomas Davis, MD, of St. John Hospital in Detroit, Michigan and James McKinsey, MD, of Columbia Presbyterian Hospital in New York, New York.

The primary endpoints were based on prospective target performance goals (TPG). The primary safety endpoint was freedom from major adverse events (MAE) at 30 days, as assessed by independent physician adjudication. This endpoint was met if the lower limit of the one-sided 95% confidence interval was found to be above 80%. The primary efficacy endpoint was technical success, defined as acute debulking with residual stenosis of ≤ 50% with the Phoenix atherectomy system before adjunctive treatment. This endpoint was successfully met if the lower limit of the one-sided 95% confidence interval was above 86%.

Dr. Williams reported that the 30-day freedom from MAE rate was 94.3% (99/105), and technical success was achieved in 95.1% (117/123) of the lesions treated. Therefore, both the primary safety and efficacy endpoints met the prospective TPGs. The Phoenix atherectomy system, as demonstrated in the EASE study, appears to be safe and effective for the debulking of atherosclerotic lesions in infrainguinal arteries.