MENLO PARK, CA – October 21, 2013 – AtheroMed, a developer of innovative catheter technologies for treating peripheral artery disease (PAD), announced results from its Endovascular Atherectomy Safety and Effectiveness (EASE) study during a Late Breaking Clinical Trials Session at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas. Stephen Williams, MD, Director of the Vascular Medicine Center at Johns Hopkins University, presented the results of the study, which demonstrate the safety and effectiveness of the Phoenix Atherectomy System in treating PAD.
EASE is a prospective, multi-center, single-arm study of 105 patients (123 lesions) in the United States and Germany that evaluated the Phoenix Atherectomy System in the treatment of lesions in the lower extremity arteries. The Phoenix System is a novel atherectomy device that uses a front-cutting, low profile design to continuously cut, capture, and clear atheroma from the patient without requiring specialized capital equipment. Co-Principal Investigators of the study are Dr. Thomas Davis, St. John Hospital (Detroit, MI), and Dr. James McKinsey, Columbia Presbyterian Hospital (New York, NY).
The results presented by Dr. Williams highlight that the Phoenix System achieved its pre-defined performance goals to demonstrate safety and effectiveness. 95.1% of the lesions treated achieved technical success, and, at 30 days, 94.3% of patients were free from Major Adverse Events. Flow-limiting dissections (Grade C or D) were observed in 1.9% of lesions with bail-out stenting required in 0.95% of lesions. Intervention due to distal embolization was limited to 0.95% of lesions.
Read more: http://www.atheromedinc.com/atheromed-announces-results-of-the-ease-study-evaluating-the-phoenix-atherectomy-system-in-treating-peripheral-artery-disease/
AtheroMed announces results of the EASE study evaluating the Phoenix Atherectomy System in treating peripheral artery disease