Available in 34mm, 38mm lengths and 3.0mm, 3.5mm and 4.0mm diameters sizes, the stent enables physicians to treat long coronary lesions, in patients with diabetes, which are considered to span more than 27mm.

In addition, the new sizes of stent reduce procedure time and cost for clinicians and hospitals, as well as vessel trauma and contrast exposure for patients.

The approval was based on the positive results from the company’s global Resolute clinical program including a pre-specified analysis of one-year outcomes in long coronary lesions patients, who participated in the Resolute US and Resolute Asia studies.

The study included data on 222 patients who received a 38mm Resolute stent for the treatment of coronary lesions of no greater than 35mm in length.

The primary endpoint for the trial includes Target lesion failure (TLF) including a composite of cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR) at one year of follow-up.

The study met its primary endpoint with a one-year TLF rate of 4.5% as well as one-year TLF rate was similarly low at 6.0% among 38% of patients with diabetes, claims the company.

In addition, the one-year rates of clinically driven TLR for all patients and the subset of diabetes patients were 1.4% and 2.4% respectively.