(By Balachander) Medtronic Inc. (NYSE: MDT) said it has received approval from the U.S. health regulators for longer lengths of the company's Resolute Integrity drug-eluting stent with an indication for patients with diabetes.
The new sizes of the Resolute Integrity stent enable the treatment of long coronary lesions, which are generally considered to span more than 27mm, the Minneapolis-based medical technology said.
Medtronic added that 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.
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The U.S. Food and Drug Administration (FDA) has cleared the 34mm and 38mm lengths of the company's Resolute Integrity drug-eluting stent in diameters of 3.0mm, 3.5mm and 4.0mm.
The company said 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.
The FDA approval is based on an analysis that 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 stock, which has been trading in the 52-week range of $35.67 to $47.40, inched up 0.36 percent to trade at $44.88 on Monday.