Coronary Patient Indication & Safety Information

INDICATIONS & IMPORTANT SAFETY INFORMATION

The Diamondback 360® Coronary Orbital Atherectomy Systems (OAS) are percutaneous orbital atherectomy systems 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.
Important Safety Information: OAS is not indicated in cases where the plaque cannot be crossed; in previously placed stents/grafts; or in patients with evidence of thrombus or plaque fractures, women who are pregnant, children, and unsuitable candidates for blood vessel interventions and coronary bypass surgery. Treatment may damage forked or excessively curved blood vessels. For additional information about risks associated with this procedure please talk to your doctor. The detailed OAS Instructions for Use including warnings and precautions is available at www.csi360.com or by calling CSI at 1-877-274-0901.
Caution: USA Federal law restricts this device to sale by or on the order of a physician.