Specifications

Diamondback360®CoronaryOrbitalAtherectomySystem
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1. System description
The Cardiovascular Systems, Inc. (CSI) DIAMONDBACK 360 Coronary Orbital
Atherectomy System (OAS) is a catheter-based system designed for facilitating stent
delivery in patients with coronary artery lesions. The OAS consists of the hand-held CSI
DIAMONDBACK 360
Coronary Orbital Atherectomy Device (OAD), the CSI Saline
Infusion Pump (OAS pump), the CSI VIPERWIRE Advance Coronary Guide Wire
(VIPERWIRE guide wire), and the CSI VIPERSLIDE Lubricant. The OAS reduces
coronary plaque on the vessel wall by using a rotating, diamond-coated crown, within
coronary arteries, in order to facilitate stent delivery.
The OAS consists of the following:
 DIAMONDBACK 360 Coronary Orbital Atherectomy Device Model DBEC-125 or
DBEC-150
 Orbital Atherectomy System Pump Model SIP-3000
 VIPERWIRE Advance Coronary Guide Wire Model GWC-12325LG-FLP
 VIPERSLIDE Lubricant Model VPR-SLD2
Caution: The OAD and VIPERWIRE Guide Wire are for use with DIAMONDBACK 360
coronary OAS components only.
1.1 Orbital Atherectomy Device (OAD)
The orbital atherectomy device (OAD) is a hand-held, over-the-wire device that
includes a sheath-covered drive shaft and a diamond-coated crown (Figure 1).
The diamond coating on the crown provides an abrasive surface with which to
reduce coronary plaque within coronary arteries. The OAD is designed to track
and rotate only over the CSI VIPERWIRE Advance Coronary Guide Wire. Do not
use any other guide wire with the OAD. Select a crown size according to the
crown’s ability to cross the coronary artery lesion and based upon the maximum
lumen potential of the crown. See Table 1 for available crown sizes. See
Appendices B and C for orbit performance.