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RADIAL PCI?

YOU’RE
PREPARED.
Diamondback 360® Coronary Orbital Atherectomy
System is the only atherectomy device to:
• Enable treatment of 2– 4 mm vessels
with a single crown through a 6 Fr sheath
• Offer quick and easy set-up in less
than 2 minutes
• Optimize stent deployment 1
When you choose Radial PCI for patients with
severe calcium, think Diamondback.

Procedures using a radial approach, compared
to femoral approach have fewer access site
complications,2 shorter time to ambulate,
and generally reduced costs.3

1. Chambers JW, Feldman RL, Himmelstein SI, et al. Pivotal trial to evaluate the safety and efficacy of the orbital atherectomy system in treating de novo, severely calcified coronary lesions (ORBIT II). JACC
Cardiovasc Interv. 2014;7:510-8.
2. Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.
Lancet.2011;377:1409-20.
3. Ruisi M, Zachariah J, Ratcliffe J, et al. Safety and Feasibility of the Coronary Orbital Atherectomy System via the Transradial Approach. J Invasive Cardiol.2015;27(11):E252-E255.
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. ©2016 Cardiovascular Systems, Inc. EN-2885.A 0116

WWW.WHYORBITAL.COM

877-CSI-0360