Medtronic has announced that the FDA has approved two new lengths—34mm and 38mm—of its Resolute Integrity drug-eluting stent in the diameters of diameters of 3mm, 3.5mm and 4mm with an indication for patients with diabetes.
Now available to cardiac catheterisation laboratories in the USA, these new sizes of the Resolute Integrity stent enable the treatment of long coronary lesions, which are generally considered to span more than 27mm.
A Medtronic press release reported that the 34mm and 38mm lengths, like the core sizes of the stent, of the Resolute Integrity stent are uniquely indicated for treating the coronary artery disease of patients with diabetes, who commonly present with long lesions.
“Long coronary lesions and diabetes represent two distinct but often inter-related clinical challenges,” said Ronald Caputo, director of cardiac services and cardiology research at St. Joseph’s Hospital in Syracuse, USA. “The new sizes of the Resolute Integrity drug-eluting stent address both challenges in a single device. They have the potential to reduce procedure time and cost for clinicians and hospitals, as well as vessel trauma and contrast exposure for patients.”
FDA approval of the 34mm and 38mm lengths of the Resolute Integrity stent is based on data from the global RESOLUTE clinical programme, which was a pre-specified analysis of one-year outcomes in patients with long coronary lesions who participated in the RESOLUTE US and RESOLUTE Asia studies.
The analysis 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 analysis was target lesion failure (TLF) at one year of follow-up.
The long-lesion analysis met its primary endpoint, with a one-year TLF rate of 4.5%. Among the 38% of patients with diabetes, the one-year TLF rate was similarly low at 6%. The one-year rates of clinically driven TLR for all patients and the subset of diabetes patients were 1.4% and 2.4%, respectively.