CardioSource WorldNews July 2015 | Page 15

COMPLEX PCI?

YOU’RE PREPARED.
Diamondback 360® Coronary Orbital Atherectomy System for severely calcified lesions:
• Offers quick and easy set-up time of <2 min
• Continuous flow during orbit minimizes the risk of thermal injury
• Enables successful stent deployment

3.4%
TLR in DES

The only device indicated for
de novo severe coronary calcium.

*ORBIT II 1-year data. DES-only subset of subjects.
Overall 1-year MACE rate of 16.4%.
Indication: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who
are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. Contraindications: The OAS is contraindicated when the ViperWire® guide wire cannot pass across the coronary
lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic
evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children. Warnings/Precautions: Performing
treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in
the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. See the
instructions for use before performing Diamondback 360 coronary orbital atherectomy procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential
adverse events. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
CSI and Diamondback 360 are registered trademarks of Cardiovascular Systems, Inc. ©2015 Cardiovascular Systems, Inc. EN-1534.A 0715

1 Généreux P, Lee AC, Kim CY, et al. Orbital Atherectomy for Treating
De Novo Severely Calcified Coronary Narrowing (1-Year Results from the Pivotal ORBIT II Trial). Am
J Cardiol. 2015;115(12):1685-90.

WWW.CONQUERCALCIUM.COM
877-CSI-0360