October 22, 2013 — AtheroMed, a developer of 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, M.D., director of the Vascular Medicine Center, 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, multicenter, 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 an 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 Thomas Davis, St. John Hospital, and James McKinsey, Columbia Presbyterian Hospital.
The results presented by Williams highlight that the Phoenix system achieved its pre-defined performance goals to demonstrate safety and effectiveness: 95.1 percent of the lesions treated achieved technical success, and, at 30 days, 94.3 percent of patients were free from major adverse events. Flow-limiting dissections (Grade C or D) were observed in 1.9 percent of lesions with bail-out stenting required in 0.95 percent of lesions. Intervention due to distal embolization was limited to 0.95 percent of lesions.
"The results from the EASE study are very encouraging and are consistent with pivotal trials for other atherectomy devices," said Williams. "With more than 70 percent 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 Thomas Zeller, head of the department of angiology, Herzzentrum University 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."
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