The US Food and Drug Administration (FDA) has approved Medtronic's Resolute Integrity™ drug-eluting stent (DES), designed for the treatment of coronary artery disease (CAD).
The device's approval follows results from a global series of trials with the Resolute DES, which demonstrated consistently good clinical performance across a broad spectrum of patients, including patients with diabetes.
The global RESOLUTE clinical programme included a large randomised controlled trial and a series of confirmatory single-arm studies involving more than 5,100 patients at nearly 250 sites in 32 countries.
RESOLUTE US enrolled 1,402 patients across 128 US-based clinical trial sites.
At one year of follow-up in RESOLUTE US, the results included low rates of target lesion failure, clinically-driven target lesion revascularisation and definite/probable stent thrombosis.
Sponsored by Medtronic, the RESOLUTE All-Comers study enrolled nearly 2,300 patients at 17 centres, and the one- and two-year results of the study were published in The New England Journal of Medicine and The Lancet, respectively.
One of the principal investigators of the RESOLUTE US clinical study, Martin B. Leon, said, "The Resolute Integrity DES offers several notable benefits, starting with outstanding deliverability, which means it's exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment."
"With the device's compelling combination of deliverability, efficacy and safety, not to mention that it is the first DES approved for patients with diabetes, the Resolute Integrity DES promises to gain rapid acceptance in cath labs nationwide," Leon added.
Medtronic coronary and renal denervation business president Sean Salmon said, "The new Resolute Integrity DES comes to US cath labs with compelling clinical evidence and a highly differentiated stent platform."
"Our next-generation zotarolimus-eluting coronary stent has gained wide global acceptance for its remarkable ability to successfully meet clinical and anatomic challenges that interventional cardiologists confront in their everyday practice," Salmon added.
In two separate large randomised controlled trials, the Resolute DES matched the safety and effectiveness of Abbott Laboratories' Xience V® DES.
Medtronic provides medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.