Clinical Trials Summary; Equipment, Setup, And Test - Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual

• Bleeding complications which may require transfusion
• Cerebrovascular accident (CVA)
• Death
• Distal embolization
• Entry site complications
• Hemolysis
• Hypotension/hypertension
• Infection
• Myocardial infarction
• Pain
• Pseudoaneurysm
• Restenosis of treated segment that may require revascularization
• Renal insufficiency/failure
• Slow flow or no reflow phenomenon
• Thrombus
• Vessel closure, abrupt
• Vessel injury, including dissection and perforation that may require surgical repair
• Vessel spasm
• Vessel occlusion

10. Clinical Trials Summary

See www.CSI360.com

11. Equipment, Setup, and Test

11.1. Equipment
In addition to the OAS components, equip the operating room with the following:
• Introducer, guide sheath, or guide catheter - see Appendix B for sizing
recommendations
• Standard IV pole with five wheels and a 20 inch diameter base
• 1000 mL bag of normal saline
• Fluoroscopic imaging equipment
• Standard hospital grade, electrical wall outlet
• Other equipment, as needed, for interventional procedures
11.2. OAS Pump Set Up
1. Use the IV pole screw clamp to attach the OAS pump to a standard IV pole making
sure to attach the OAS pump to the IV pole at a distance not greater than 60 in (153
cm) from the floor to the top edge of the OAS pump.
for clinical trial information
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