The FDA issued clearance for the 4 Fr 1.25 Solid Diamondback 360 Peripheral Orbital Atherectomy System to treat patients with peripheral artery disease (PAD).
Cardiovascular Systems’ new percutaneous devices have two crown designs, a 1.25mm Solid Crown and a 1.25mm Micro Crown, and provide a smaller profile and a more flexible shaft, according to the company. Both designs are 4 Fr sheath compatible and will allow physicians to treat PAD patients below the knee through the groin or to treat the upper leg through the foot.
In March of 2014, the St. Paul, Minn.-based company received FDA clearance for 60cm atherectomy system to treat lesions in the lower leg. The agency gave the Diamondback Orbital Atherectomy System 510(k) clearance in 2007.