US-based AtheroMed has announced results from its ‘Endovascular Atherectomy Safety and Effectiveness’ (EASE) study, designed to evaluate the safety and effectiveness of the Phoenix Atherectomy catheter in treating lesions in the lower extremity arteries.
The EASE study is a prospective, multi-centre, single-arm study and has enrolled 105 patients (123 lesions) in the US and Germany.
It was conducted under an investigational device exemption to support the US Food and Drug Administration clearance (FDA) of the Phoenix Atherectomy System for the treatment of de-novo and restenotic lesions of lower extremity arteries.
The Phoenix is a peripheral atherectomy catheter system, designed to cut, capture and clear atheroma from the patient without requiring specialised capital equipment.
It provides physicians with a safe, versatile, easy to use front-line therapy that can potentially make atherectomy available to more tough-to-treat patients with clinically challenging lesions.
Johns Hopkins University’s Vascular Medicine Center director Dr Stephen Williams presented the study’s results at the Vascular Interventional Advances (VIVA) 2013 conference in Las Vegas.
Dr Williams said the results from the EASE study were encouraging and consistent with pivotal trials for other atherectomy devices.
“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,” Dr Williams said.
Dr Williams highlighted that the Phoenix system has met its pre-defined performance goals to demonstrate safety and effectiveness. He also reported that the 30-day freedom from Major Adverse Events rate was 94.3%, and technical success was achieved in 95.1% of the lesions treated.
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 embolisation was limited to 0.95% of lesions.
AtheroMed president and CEO Mike MacKinnon said the company believes 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.
“This EASE data continues to support the use of the Phoenix System as a frontline therapy, and we are excited to bring this treatment option to physicians and their patients,” MacKinnon said.
The Phoenix system has received CE Mark approval but is investigational and not yet available for sale in the US.
According to GlobalData estimates, the peripheral vascular devices market was valued at $2.26bn in 2012 and is expected to grow at a CAGR of 3.2% to reach $2.82bn by 2019.