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FDA approves new sizes of Resolute Integrity stent
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Medtronic has announced FDA approval of the 34 mm and 38 mm lengths of its Resolute Integrity drug-eluting stent in diameters of 3 mm, 3.5 mm and 4 mm, which include an indication for patients with diabetes.
According to a press release, the stents are available to cardiac catheterization laboratories nationwide and allow for the treatment of long coronary lesions, which tend to extend more than 27 mm.
Similar to the core sizes approved in February 2012, the 34-mm and 38-mm lengths of the Resolute Integrity stent are indicated for the treatment of coronary artery disease among patients with diabetes.
“Long coronary lesions and diabetes represent two distinct but often interrelated clinical challenges,” director of cardiac services and cardiology research at St. Joseph’s Hospital in Syracuse, N.Y., Ronald Caputo, MD, said in a press release. “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.”
The approval is based on data from the global RESOLUTE clinical program. According to the release, the long-lesion analysis met its primary endpoint, with a 1-year target lesion failure (TLF) rate of 4.5%. Similarly, the 1-year TLF rate was low (6%) among the 38% of patients with diabetes. Furthermore, the 1-year rates of clinically driven target lesion revascularization were 1.4% for all patients and 2.4% the subset of diabetes.
According to the release, these new lengths have the potential to cut procedure time and cost for clinicians and hospitals, and decrease vessel trauma and contrast exposure for patients.