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STUDY ASSESSED SAFETY AND EFFECTIVENESS OF THE PHOENIX SYSTEM
MENLO PARK, Calif., Oct. 21, 2013 /PRNewswire/ -- 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.
"The results from the EASE study are very encouraging and are consistent with pivotal trials for other atherectomy devices," says Dr. Williams. "With more than 70% of the patients in the study suffering from blockages at or below the knee, the Phoenix System is likely to be a promising treatment alternative for these challenging procedures."
"I was pleased to see the positive results of the EASE data released at VIVA," said Prof. Thomas Zeller, Head of the Department of Angiology at the Herz-Zentrum in Bad Krozingen, Germany. "These results are in line with my own experience with the Phoenix Catheter, and I look forward to it being made available to my patients in the near future."
"We believe that the combination of the front cutting design and the continuous capture and clear mechanism of action of the Phoenix System makes it the ideal solution for treating below the knee disease," said Mike MacKinnon, President and CEO of AtheroMed. "This EASE data continues to support the use of the Phoenix System as a front-line therapy, and we are excited to bring this treatment option to physicians and their patients."
About the Phoenix Atherectomy System
The Phoenix Atherectomy System is a peripheral atherectomy system that has been specifically designed to enhance 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. 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. It has received CE Mark approval for commercialization outside the US.
AtheroMed, Inc., based in Menlo Park, California, is dedicated to developing innovative 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.
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