Evaluation of the Diamondback 360 Coronary Orbital Atherectomy System for treating de novo, severely calcified lesions.

Coronary lesions with severe (or heavy) calcification are classified as complex lesions and are known to carry lower success rates and higher complication rates following percutaneous coronary intervention. The Diamondback 360(®) Coronary Orbital Atherectomy System is the first and only device approved for use in the USA as a treatment for severely calcified coronary lesions to facilitate stent delivery and optimal deployment. Availability of this device provides a safe and effective option for physicians to improve treatment outcomes in this patient population with severely calcified coronary lesions.