AtheroMed has obtained marketing approval from the US Food and Drug Administration (FDA) for its Phoenix atherectomy system for treating peripheral artery disease (PAD).
Phoenix atherectomy system is a peripheral atherectomy catheter system that has been specifically designed to enhance the treatment of PAD.
It provides physicians with a safe, versatile, easy to use front-line therapy that can potentially make atherectomy available to a broader range of patients.
Using a rotating, front-cutting element located at the distal tip of the catheter, the over-the wire system shaves material directly into the catheter. An internal Archimedes Screw, running the length of the catheter, then continuously captures and removes the debulked material.
The device is available in various sizes to treat diseased vessels from the thigh to the foot with catheter sizes down to 1.8mm in diameter with a 5F profile.
AtheroMed president and CEO Mike MacKinnon noted the FDA clearance to market the Phoenix atherectomy system marks a significant milestone for the company and allows it to begin improving the lives of patients suffering from PAD.
"The Phoenix Atherectomy System combines a low profile, flexible catheter shaft design with a mechanism of action that continuously clears debris from the body, so physicians can now safely perform atherectomy in vessels that previously may have been out of their reach. We are excited to now bring this treatment option to physicians and their patients," MacKinnon added.