The system consists of a catheter with a rotating crown that "sands" down plaque deposits to help restore blood flow in limbs affected by PAD.
"Securing CE Mark for Stealth 360 greatly expands our market opportunity and is an important milestone toward benefiting patients in Europe suffering from PAD – especially those with critical limb ischemia, or CLI, who have been underserved by other treatment options," CEO David Martin said in a statement. "A determining factor for CLI is calcium buildup in leg arteries, particularly small vessels below the knee. Our technology, with its unique mechanism of action, has demonstrated it can safely and effectively treat this complex disease, with lasting results."
The Stealth 360 device 1st won 510(k) clearance from the FDA in 2011.
In August, CSI recalled some of its Diamondback 360 orbital atherectomy devices on the risk that a component could fracture during procedures, possibly causing an embolism.