Diamondback 360® Orbital Atherectomy Device, Solid Crown, 30 µm, with 15 cm Travel Instructions for Use © 2011 Cardiovascular Systems, Inc. 90168-00.
Table of Contents List of Illustrations and Tables 2 Introduction 3 Diamondback 360 Orbital Atherectomy System (OAS) Description 3 Indications For Use 3 Contraindications, Restrictions, Warnings and Precautions 3 Contraindications 3 Restrictions 3 Warnings 3 Precautions 4 Clinical Summary 5 Diamondback 360 Orbital Atherectomy Device (DB 360) 6 Crown Size Selection 7 Diamondback Procedure 8 Background Information 8 Introducer Sheath 8 Guide Wire Placement 8 Equipment Set Up 8
Introduction The following Instructions for Use describe the components and use of the Diamondback 360º Orbital Atherectomy System (OAS). Read these instructions thoroughly before using the OAS or any of its components. Review the contraindications, restrictions, warnings, and precautions carefully. Additional instructions and information may be found in the Orbital Atherectomy Controller Manual.
• • • • • • • • • • • Handle the DB 360 and guide wire carefully. A tight loop, kink, or bend in the guide wire may cause damage and system malfunction during use. Never operate the DB 360 without normal saline solution (saline) infusion. Flowing saline is required for cooling and lubricating of the DB 360 turbine. Operation of the DB 360 without proper saline infusion may result in over heating and permanent damage to the DB 360 and possible patient injury.
Clinical Summary The prospective multi-center Clinical Study of the Orbital Atherectomy System for the Treatment of Peripheral Vascular Stenosis [OASIS] was conducted to evaluate the safety and effectiveness of Orbital Atherectomy in patients with symptomatic PAD. 124 patients from 17 contributing centers were enrolled, and 201 lesions were treated with OA.
Diamondback 360 Orbital Atherectomy Device (DB 360) The DB 360 includes the following subcomponents: • Control Handle – Supports the air turbine. • Triple Cable with Quick Connector – includes: o Optical Tachometer Fiber – Connects to the Controller and provides for measurement of Shaft/Crown rotational speed; o Turbine Gas Intake Hose – Delivers compressed gas from the Controller to the Control Handle; o Saline tubing – Used to deliver saline from the saline bag to the DB 360.
Crown Size Selection Crown Sizes The eccentric diamond-coated Crown is available in diameters as listed in Table 1. Each Crown size has a specific nose length (nose length is the length of the drive shaft from the Crown to the shaft tip). Table 1. Crown Sizes Crown Size Nose Length (mm) 1.50 mm 10 1.75 mm 15 2.00 mm 15 2.
Diamondback 360 Orbital Atherectomy Procedure Background Information The eccentric diamond-coated Crown of the DB 360 is designed to remove a thin layer of the stenotic lesion with each pass through the lesion. It is recommended that debulking be initiated at Low speed. Frequent fluoroscopic visualization allows for controlled removal of the lesion. Increase rotational speed, as required, to increase the orbit diameter. Introducer Sheath An introducer sheath is used to access the target vessel.
Ability to Advance the Crown After setting the correct rotational speed of the Shaft/Crown, practice advancing the Crown while it is rotating. 1. Hold the Sheath a few centimeters from the Crown making sure that the Crown is not in contact with any objects. 2. Depress and release the Foot Pedal. Saline will flow at high pump speed. 3. Within five seconds, depress and hold the Foot Pedal. The Shaft/Crown will rotate. 4.
Rest periods are recommended after 30 to 60 seconds of treatment time with a maximum treatment time of 90 seconds. Do not leave the rotating Crown in one location for more than 2-3 seconds. Use contrast injections through the introducer sheath to evaluate the results angiographically. Stop Crown rotation by releasing the Foot Pedal. To begin Crown rotation again: a. Depress and release the Foot Pedal to start the flow of saline at high pump speed. b.
Troubleshooting Issue The Crown stops rotating during the atherectomy procedure. Blood is observed in the Sheath. Crown/Shaft fractures. The desired rotational speed cannot be reached. Variable or unstable rotational speed is displayed. No Crown activation No saline flow Solution Discontinue treatment immediately. Retract the Crown. Check the Control Handle for proper connection to the Controller. If the connections are correct, use fluoroscopy to analyze the situation. 1. Discontinue treatment. 2.
Appendix A – Platform Graphs 1.50mm 30µm Solid Crown Orbit Results Low (80 krpm) Med (140 krmp) High (200 krpm) 4 Pin Diameter(mm) 3.5 3 Treated Simulated 2.0x Vessel 2.5 2 1.5 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 Number of passes (~1 minute 10 passes) 1.75mm 30µm Solid Crown Orbit Results Low (80 krmp) Med (140 krmp) High (200 krmp) 4.25 Pin Diameter(mm) 3.75 3.25 Treated Simulated 2.0x Vessel 2.75 2.25 1.
2.00mm 30µm Solid Crown Orbit Results Low (80 krpm) Med (120 Krpm) High (160 Krpm) 5.5 5 Pin diameter(mm) 4.5 4 3.5 Treated Simulated 2.0x Vessel 3 2.5 2 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 Number of passes (~1 minute 10 passes) 2.25mm 30µm Solid Crown Orbit Results Low(60 Krpm) Med (90 Krpm) High(120) 4.75 Pin Diameter(mm) 4.25 Treated Simulated 2.0x Vessel 3.75 3.25 2.75 2.
Appendix B - Maximum Orbit/Resulting Lumen Diameter Table 3 shows the maximum orbit/resulting lumen diameter for each DB 360 Crown at incremental rotational speeds for 50 passes (about 5 minutes of treatment time.) To demonstrate that the orbit of the DB 360 has a maximum limit, Table 4 summarizes the results at the maximum sanding time for each DB 360 Crown diameter (maximum rotational speed for 90 passes, about 8 minutes of treatment time).
Appendix C - Recommended Introducer Sheath Sizes Crown Size Diamondback 360 Maximum Outer Diameter Recommended Introducer Sheath Internal Diameter 1.50 mm (0.062 inches) 1.8 mm (0.070 inches) 0.079 inches (6 F) 1.75 mm (0.070 inches) 1.8 mm (0.070 inches) 0.079 inches (6 F) 2.00 mm (0.079 inches) 2.0 mm (0.079 inches) 0.079 inches (6 F) 2.25 mm (0.089 inches) 2.25 mm (0.089 inches) 0.089 inches (7 F) © 2011 Cardiovascular Systems, Inc.
Appendix D: Symbols Model Number Lot Number Use By Date Refer to the Instructions For Use Do not re-use Sterilized with Ethylene Oxide Manufacturer Contains phthalate: bis (2-ethylhexyl) phthalate (DEHP) © 2011 Cardiovascular Systems, Inc. 16 90168-00.
Appendix E - DISCLAIMER OR WARRANTY DISCLAIMER OF WARRANTY Although Cardiovascular Systems, Inc. (CSI) uses reasonable care n the manufacture of its devices, they are used in difficult environment within the human body with many biological differences between individual patients CSI has no control over the conditions under which this device is used, condition of the patient, methods of administration or handling after the device leaves CSI’s possession.
