The US Food and Drug Administration (FDA) has approved Medtronic's new sizes of its Resolute Integrity drug-eluting stent for the treatment of coronary artery disease in patients with diabetes.
The new 34mm, 38mm lengths and 3.0mm, 3.5mm and 4.0mm diameters of the stent enable physicians to treat long coronary lesions, which are considered to span more than 27mm.
St Joseph's Hospital cardiac services and cardiology research director Dr Ronald Caputo said long coronary lesions and diabetes represent two distinct but often interrelated clinical challenges.
"The new sizes of the Resolute Integrity drug-eluting stent address both challenges in a single device," Caputo said.
The new sizes of stent also 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 programme, 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.
Target lesion failure (TLF) including a composite of cardiac death, target vessel myocardial infarction and clinically-driven target lesion revascularisation (TLR) at one year of follow-up is the primary endpoint for the trial.
The study met its primary endpoint with a one-year TLF rate of 4.5%, which rose to 6.0% among patients with diabetes.
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, according to the company.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha'Eri.