The FDA has granted 510(k) clearance to AtheroMed’s 5F, 6F and 7F front-line Phoenix Atherectomy System for use in clearing debris from lower leg vessels in patients with peripheral artery disease, the devicemaker said Monday.
The Phoenix system — which comes in sizes down to 1.8 mm in diameter with a 5F profile — includes a low-profile atherectomy catheter that can continuously remove diseased material without requiring specialized capital equipment, according to the Menlo Park, Calif., company. The over-the-wire system uses a rotating, front-cutting element at the catheter’s distal tip to collect material directly into the catheter. An Archimedes screw then removes that material from the catheter.
These features are ideal for below-the-knee lesions, as they provide physicians with greater access to that area while reducing procedure time and minimizing potential complications, such as distal embolization, the company told Device Daily Bulletin.
AtheroMed plans to launch the Phoenix system, its flagship product, in the U.S. in the second or third quarter of this year. The system already has CE mark approval, said spokesman Paul Escueero. — Lena Freund
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