Via AtheroMed:
MENLO PARK, CA – October 2, 2013 – AtheroMed, a developer of innovative technologies for treating peripheral artery disease (PAD), announced that it has completed patient enrollment in the EASE clinical study. The EASE study results will be presented by Dr. Stephen Williams, Director, Vascular Medicine Center at Johns Hopkins University, during a Late Breaking Clinical Trials Session on Wednesday, October 9th, at the Vascular Interventional Advances (VIVA) conference in Las Vegas.
The EASE study was a prospective, multi-center, 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 IDE to support US FDA clearance and enrolled 105 patients at 16 sites in the US and Germany. Outcome assessments were made after the baseline procedure and at 30-day and 6-month follow-up visits. Co-Principal Investigators of the study were Dr. Thomas Davis, St. John Hospital (Detroit, MI), and Dr. James McKinsey, Columbia Presbyterian Hospital (New York, NY).
“Peripheral arterial disease, especially blockages located below the knee, continues to present challenges, even with currently available technologies,” said Dr. Davis. “Based on my case results in the EASE study, the Phoenix Atherectomy System appears promising as a front-line therapy for treating PAD.”
Read more: http://www.atheromedinc.com/atheromed-announces-completion-of-patient-enrollment-in-the-ease-study-evaluating-the-phoenix-atherectomy-system-in-treating-pad/
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