FDA Clears AtheroMed’s Phoenix Atherectomy System For Peripheral Artery Disease


January 28, 2014
AtheroMed Phoenix Atherectomy System Device Peripheral Artery Disease PAD
January 28, 2014 — AtheroMed, a developer of catheter technologies for treating peripheral artery disease (PAD), received clearance from the U.S. Food and Drug Administration (FDA) to market the Phoenix Atherectomy System. This system allows physicians to treat PAD with a low profile atherectomy catheter that continuously removes diseased material as it is debulked and does not require specialized capital equipment.
"Peripheral artery disease, especially lesions located below the knee, can be challenging to treat, even with currently available technologies," said Thomas Davis, M.D., director of the cardiac catheterization lab and director of peripheral interventions and disease, St. John Hospital and Medical Center, Detroit, Mich. "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."
The Phoenix Atherectomy System is a peripheral atherectomy over-the wire system that 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 continuously captured 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 down to 1.8 mm in diameter with a 5-French profile.
For more information: www.atheromedinc.com