AtheroMed secured 510(k) clearance from the FDA for its Phoenix device, an atherectomy catheter used for treating peripheral artery disease.
The low-profile catheter aims to minimizes vessel interaction and designed to be easy to set up. The Phoenix system features front-cutting technology that cuts while clearing away clearing debris with an internal Archimedes screw, which runs the length of the catheter. The device is available in a variety of sizes, according to a press release.
“FDA clearance to market the Phoenix Atherectomy System marks a significant milestone for our company and allows us 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,” president and CEO Mike MacKinnon said in prepared remarks.
This clearance marks a major milestone for a company that previously had a 1-page website. AtheroMed raised $4.3 million to support its operations and clearance for the Phoenix.
