OASIS: a prospective, multi-center, IDE clinical study, was conducted to evaluate the efficacy and safety
of the Diamondback 360° System. In 124 patients with 201 lesions, results met or exceeded FDA Objective
Performance Criteria (OPC) targets.*
Primary safety endpoint Cumulative number of patients with
serious adverse events through 30 days
16% SAE’s
8% SAE’s
4% Device Related
p<0.05
Secondary efficacy/safety endpoint TLR rate through 6 months
20%TLR
0.9%TLR
p<0.00001, power = 0.99
119 out of 124 patients treated at 30 day endpoint had no device related SAE’s
2 minor perforations (1 distal to treated area following angioplasty)
1 distal embolization
* OASIS Clinical Study – CSI 2006 (Orbital
Atherectomy System for the Treatment of Peripheral Vascular Stenosis)
For more information about the new Diamondback 360°™ Orbital Atherectomy System from CSI, please contact your local CSI representative or call customer service at 877.CSI.0360
