FDA Clears AtheroMed's Phoenix Atherectomy System to Treat Peripheral Artery Disease

January 27, 2014—AtheroMed, Inc. (Menlo Park, CA) announced that it has received US Food and Drug Administration (FDA) clearance to market the Phoenix atherectomy system for the treatment of peripheral artery disease. The Phoenix device is a low-profile atherectomy catheter that continuously removes diseased material as it is debulked. It does not require specialized capital equipment.

According to the company, the Phoenix peripheral atherectomy system is designed to provide physicians with a safe, versatile, easy-to-use primary therapy for treating PAD to restore blood flow to the ankle and foot. The over-the-wire system uses a rotating, front-cutting element located at the distal tip of the catheter to shave material directly into the catheter. The debulked material is then captured continuously and removed by an internal Archimedes screw running the length of the catheter. The Phoenix atherectomy system is available in multiple sizes to treat diseased vessels from the thigh to the foot, with catheter sizes as small as 1.8 mm in diameter and 5 F in profile.

In AtheroMed’s release, Thomas Davis, MD, commented, “Peripheral artery disease, especially lesions located below the knee, can be challenging to treat, even with currently available technologies. My experience with the Phoenix device during the EASE clinical study was extremely positive, and I am excited that the device is now available, as it will allow me to debulk small vessels that I may not have been able to treat in the past.” Dr. Davis is Director of the Cardiac Catheterization Lab and Director of Peripheral Interventions and Disease at St. John Hospital and Medical Center in Detroit, Michigan.

Dr. Davis and James McKinsey, MD, are the principal investigators of the EASE trial, which supported FDA clearance. In October 2013, Steve Williams, MD, presented the EASE study data at the VIVA 2013: Vascular Interventional Advances conference in Las Vegas, Nevada.