Expert Rev Med Devices
September 2014
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.
View Article and Find Full Text PDFIntroduction: As cost considerations become increasingly critical when selecting optimal endovascular treatment strategies, a cost-benefit analysis was conducted comparing the Diamondback 360°® Orbital Atherectomy System (OAS) (Cardiovascular Systems, Inc., St Paul, MN, USA) and balloon angioplasty (BA) vs BA alone for treatment of calcified femoropopliteal lesions.
Patients And Methods: The clinical outcomes from COMPLIANCE 360°, a prospective, multicenter, randomized study comparing OAS+BA vs BA alone for treatment of calcified femoropopliteal lesions, were correlated with cost data and previously published quality of life data.
Background: Peripheral artery disease affects 8-18 million people in the United States. Patients with peripheral artery disease are known to have increased morbidity and mortality. Medical guidelines recognize ankle-brachial index testing as an effective screening tool that allows for early detection of this disease in primary care settings.
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