Boston Scientific

FDA approval of firm's NIRoyal coronary stent mounted on a Monorail delivery system via premarket approval application supplement allows for release of first gold-coated stent in the U.S., the company reports May 25. Available in lengths 9, 12, 15, 18, 25 and 31 mm and diameters of 2.0-4.0 mm in 0.5 mm increments, the device provides enhanced visibility over currently available stents, the firm claims. The product, which is said to have been delayed in gaining final agency go-ahead, is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete (de novo) lesions in native coronary arteries (length equal to or less than 25mm) with a reference vessel diameter of 3.0 - 4.0 mm; treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2.5-4.0 mm; and patients with symptomatic heart disease due to lesions in saphenous vein bypass grafts with lesion length equal to or less than 30 mm and reference diameter in the range of 3.0-4.0 mm. The firm's gold-coated NIRoyal Elite stent, which includes the SOX securement system, is pending FDA approval