Peripheral Artery Disease (PAD) device specialist AtheroMed, Inc., has released a press release in which it tells us about its Endovascular Atherectomy Safety and Effectiveness (EASE) study. Presented at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas, the results demonstrate the safety and effectiveness of the Phoenix Atherectomy System in treating PAD.
Background
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. The system has been specifically designed to enhance the treatment of PAD located below the knee. The blade design of the rotating front-cutting element shaves material directly into the catheter where the material is captured and continuously removed.
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 results were presented by Dr. Stephen Williams, MD, Director of the Vascular Medicine Center at Johns Hopkins University. According to the AtheroMed release they indicate 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 Phoenix System was also featured in the October edition of Vascular Disease Management (vol 10, issue 10). Find that piece here.
Investigator comments
“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.”
Physician comments
“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.”
Company comments
“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.”
Regulatory status
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.
Source: AtheroMed, Inc., PR Newswire, Vascular Disease Management