FDA clearance for Phoenix Atherectomy System

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AtheroMed has announced receiving US FDA approval to market the Phoenix Atherectomy System that allows physicians to continuously remove diseased material as it is debulked from patients with peripheral arterial disease, using a low profile atherectomy catheter.

“Peripheral artery disease, especially lesions located below the knee, can be challenging to treat, even with currently available technologies,” said Thomas Davis, director of the Cardiac Catheterization Lab and director of Peripheral Interventions and Disease at St John Hospital and Medical Center in Detroit, USA. “My experience with the Phoenix device during the Endovascular Atherectomy Safety and Effectiveness (EASE) 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 System is an 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 1.8mm in diameter with a 5F profile.