*Final residual stenosis <50% without stent placement or <30% residual stenosis with stent placement and without significant angiographic complications.
**Successful completion of OA treatment of target lesion via transradial access without serious transradial access related events.
1. Lodha A. REACH PVI Clinical Study Results Presentation. NCVH 2020.
The Diamondback 360® and Stealth 360® 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.