FDA Approves Longer Lengths of Medtronic’s Resolute Integrity Stent

Medtronic, Inc.  announces Monday that the U.S. Food and Drug Administration (FDA) has approved the 34mm and 38mm lengths of the Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm for patients with diabetes suffering from coronary heart disease.

Like the core sizes approved by the FDA in February 2012, the 34mm and 38mm lengths of the Resolute Integrity stent are uniquely indicated for treating the coronary artery disease of patients with diabetes, who commonly present with long lesions generally spanning more than 27mm.

“Long coronary lesions and diabetes represent two distinct but often interrelated clinical challenges,” said Ronald Caputo, M.D., director of cardiac services and cardiology research at St. Joseph’s Hospital in Syracuse, N.Y. “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 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 long-lesion analysis met its primary endpoint, with a one-year target lesion failure (TLF) –– a composite of cardiac death, rate of 4.5 per cent. Among the 38 per cent of patients with diabetes, the one-year TLF rate was similarly low at 6.0 per cent.