AtheroMed Announces Completion of Patient Enrollment in the EASE Study Evaluating the Phoenix Atherectomy System in Treating PAD
RESULTS TO BE PRESENTED DURING LATE-BREAKING CLINICAL TRIALS SESSION AT VIVA 2013
MENLO PARK, Calif., Oct. 2, 2013 /PRNewswire/ — 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 9(th), 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.”
“We believe that the Phoenix Atherectomy System provides a significant advancement to aid physicians in treating some of the most challenging PAD cases,” said Michael MacKinnon, President and CEO of AtheroMed. “We look forward to sharing the results of the EASE study at VIVA later this month. I congratulate the entire AtheroMed team and the EASE Investigators on a significant milestone achievement.”
Learn more about the Phoenix Atherectomy System by visiting booth #108 at the VIVA conference, October 8-11 in Las Vegas.
About the Phoenix Atherectomy System
The Phoenix Atherectomy System is a peripheral atherectomy system that has been specifically designed to revolutionize the treatment of PAD located below the knee. The Phoenix System is an over-the-wire device with a front-cutting element at the distal tip of the catheter. The blade design of the rotating cutting element shaves material directly into the catheter where the material is captured and continuously removed by an internal Archimedes Screw that runs the length of the Phoenix catheter. The Phoenix System has been designed in multiple sizes and is intended to provide physicians with a safe, versatile, easy to use front-line therapy. The Phoenix System is investigational and not yet available for sale in the US but has received CE Mark approval for commercialization outside the US.
AtheroMed, Inc., based in Menlo Park, California, is dedicated to developing revolutionary technology for treating disease located below the knee to quickly, safely, and effectively restore blood flow and improve the lives of the 18 million Americans suffering with PAD and save the limbs of the 3.5 million Americans with Critical Limb Ischemia (CLI), the most severe form of PAD.
For more information please visit www.atheromedinc.com.