Technology | April 03, 2019

Resolute Integrity Now Indicated for CTOs

Medtronic's Resolute Integrity Zotarolimus-eluting Coronary Stent System received an additional U.S. Food and Drug Administration (FDA) indication for treatment of de novo chronic total occlusion (CTO) lesions.

April 3, 2019 — Medtronic's Resolute Integrity Zotarolimus-eluting Coronary Stent System received an additional U.S. Food and Drug Administration (FDA) indication for treatment of de novo chronic total occlusion (CTO) lesions. The stent is also indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with reference vessel diameters of 2.25 - 4.2 mm. 

The FDA said in a clinical study, 183 patients were treated with the Resolute Integrity stent measured outcomes through 12 months after the procedure and demonstrated that the rate of major adverse cardiovascular events (defined as death, myocardial infarction, and need for a repeat procedure at the site of the originally placed stent) was lower than the rate that was observed for other stents used to treat chronic total occlusions.

For more information: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm629911.htm?utm_campaign=2019-03-25%20Recently%20Approved%20Devices&utm_medium=email&utm_source=Eloqua

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