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NEW EVIDENCE from a real-world study by Dr. Nirat Beohar and colleagues demonstrated the orbital atherectomy system to be safe and effective with excellent procedural results when treating real-world patients with severely calcified lesions. The retrospective, single-arm study entitled “Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesion: A Tertiary Center Experience” included 519 patients. Despite treating complex lesions, Dr. Beohar and team were able to cross 100% of the lesions with successful stent deployment and extremely low rates of component angiographic complication rates of <1%.

COMPONENT ANGIOGRAPHIC

COMPLICATION RATES BELOW 1%

  • 519 patients with heavily stenosed, calcified lesions

  • Patients treated with OAS at a single center

  • In-hospital outcomes

  • Observational study

PROCEDURAL OUTCOMES

Successful treatment of these heavily stenosed lesions was possible because of the dual-action technology of the Diamondback 360® Coronary Orbital Atherectomy System, which sands intimal calcium and fractures medial calcium, allowing physicians to treat severely calcified lesions with a single device.

CSI now has 11 studies that include real-world data from more than 2,200 patients with complex, severely calcified lesions who have been safely and successfully treated using the Diamondback 360® Orbital Atherectomy System (OAS).


Watch Dr. Beohar's Data Presentation
1. Vinardell, TCT2020, No. 165



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 Advance® Coronary 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.



This study was supported by a research grant from Cardiovascular Systems, Inc.

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