Peripheral – Exchangeable Professional Indication & Safety Information

INDICATION & IMPORTANT SAFETY INFORMATION

The Diamondback 360® and Stealth 360º Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae.
Important Safety Information: The Systems are contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Warning: Spinning the crown using GlideAssist can be done with the OAD guide wire brake lever in either the locked or unlocked position. If using GlideAssist with the guide wire brake in the unlocked position, the guidewire must be held using either fingers or the guide wire torquer. If using the guide wire torquer, ensure that it is securely fastened to the guide wire before starting to spin using GlideAssist.
Note: If the brake is changed from the locked or unlocked position while spinning in GlideAssist mode, the crown will automatically stop spinning, yet the OAD will remain in GlideAssist mode. GlideAssist may allow the OAD to reach more distal vasculature. Please be mindful of the OAD position relative to the vessel size, lesion location and guide wire spring tip.