FDA gives nod to Medtronics Resolute stent
Physicians will have another option when it comes to treating patients with coronary artery disease—Medtronic’s Resolute Integrity Drug-Eluting Stent (DES). FDA approved the device Feb. 20.
The agency’s decision was based on results of the RESOLUTE clinical program, in which 5,100 patients received the Resolute DES stent. RESOLUTE US, for example, showed that patients treated with the Resolute stent saw low rates of target lesion failure, target lesion revascularization and stent thrombosis. These results were achieved despite the fact that 34 percent of patients had diabetes.
While not part of the FDA dataset, results of the TWENTE trial, presented at TCT.11, showed that Medtronic's Resolute stent performed similarly to Abbott's Xience V everolimus-eluting stent in terms of safety and efficacy. Within the study, 22 percent of patinets were diabetic and 50 percent had acute coronary syndrome.
The Resolute DES is indicated to treat both patients with CAD and diabetes.
The agency’s decision was based on results of the RESOLUTE clinical program, in which 5,100 patients received the Resolute DES stent. RESOLUTE US, for example, showed that patients treated with the Resolute stent saw low rates of target lesion failure, target lesion revascularization and stent thrombosis. These results were achieved despite the fact that 34 percent of patients had diabetes.
While not part of the FDA dataset, results of the TWENTE trial, presented at TCT.11, showed that Medtronic's Resolute stent performed similarly to Abbott's Xience V everolimus-eluting stent in terms of safety and efficacy. Within the study, 22 percent of patinets were diabetic and 50 percent had acute coronary syndrome.
The Resolute DES is indicated to treat both patients with CAD and diabetes.