CardioSource WorldNews Interventions | Page 35

THE SMART SOLUTION
FOR SEVERE CALCIUM

CONQUER THE CALCIUM.

DELIVER THE STENT.

WHEN YOU SEE CALCIUM, THINK DIAMONDBACK.
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-3255.A 0716

See it in action at

WhyOrbital.com