INDICATION & IMPORTANT SAFETY INFORMATION
The Diamondback 360® and Stealth 360° Peripheral Orbital Atherectomy Systems are used to restore blood flow in the arms, legs, hands, and feet in patients with blocked blood vessels from arterial disease or dialysis treatment.
Important Safety Information: The Diamondback 360® Peripheral OAS treatment is not indicated for use in the heart, in bypass grafts, within stents, or in blood vessels with dissections or clots. Although the incidence of adverse events is rare, the Diamondback 360® Peripheral OAS treatment may result in pain; low blood pressure; death; stroke; transient ischemic attack (TIA); or angiographic complications such as perforation, distal embolization, formation of blood clots, blood in the urine, abrupt or acute vessel closure, or arterial spasm.
Caution: USA Federal law restricts this device to sale by or on the order of a physician.