Specifications

© 2011 Cardiovascular Systems, Inc. 3 90168-00.K
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. Read all manuals and instructions completely before using the
OAS or any components or performing any atherectomy procedure.
Diamondback 360◦ Orbital Atherectomy System (OAS) Description
The OAS is a percutaneous orbital atherectomy system designed to remove or reduce occlusive material and restore
luminal patency by using a rotating, eccentric diamond-coated Crown. The system is available in an 0.014 inch
platform for use with a 0.014 inch guide wire.
The 0.014 OAS consists of the following CSI supplied components:
• Diamondback 360 0.014 inch Orbital Atherectomy Device (DB 360).
• Orbital Atherectomy Controller (Controller) – See Controller Manual.
• 0.014 inch (0.3556mm) x 335 cm ViperWire™ Firm Guide Wire. (See guide wire Instructions For Use)
Additional components, which are independently obtained, are listed below. Follow the original manufacturer’s
instructions for each independently sourced component.
• ViperSlide™ Lubricant (Rotaglide™ system lubricant also compatible – refer to IFU)
• Introducer sheath (Note: See Appendix C for recommended sizes)
• Standard compressed gas (medical air or nitrogen only) cylinder and compatible regulator or appropriate
hospital compressed gas system. See the Controller Manual for more information about running the DB 360
from low pressure, house lines.
• Normal saline for infusion.
•
Indications for Use
The Diamondback 360° Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use
as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates
for percutaneous transluminal atherectomy.
The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt).
Contraindications, Restrictions, Warnings and Precautions
Contraindications
Use of the OAS is contraindicated in the following situations:
• Guide wire cannot be passed across the peripheral lesion.
• Use in coronary arteries.
• Target lesion is within a bypass graft or stent.
• Patient has angiographic evidence of thrombus; thrombolytic therapy must be instituted prior to atherectomy.
• Patient has angiographic evidence of significant dissection at the treatment site. The patient may be treated
conservatively to permit the dissection to heal before treating the lesion with the OAS.
Restrictions
• The OAS should only be used by physicians who are experienced in peripheral angioplasty at his or her
institution and trained on the use of the OAS.
• Caution: Federal Law (United States) restricts this device to sale by or on the order of a physician.
Warnings
• Reference vessel diameter at treatment area must be at least 1.5 mm in diameter.
• If mechanical failure of the OAS occurs before or during the atherectomy procedure, discontinue use immediately
and return the product to Cardiovascular Systems, Inc. Do not attempt to use a damaged DB 360, or other
system component. Use of damaged components may result in system malfunction or patient injury.
• The DB 360 should be used only with the CSI 0.014 inch (0.3556mm) x 335 cm Firm ViperWire guide wire.
Follow CSI’s instructions related to guide wire use.
• Always use fluoroscopic surveillance when advancing the guide wire to avoid misplacement, dissection, or
perforation. The guide wire functions as the monorail over which the DB 360 tracks, it is imperative that the guide
wire be initially placed through the stenotic lumen and not in a false channel.