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Approval for a new indication (elective stenting of de novo and restenotic coronary arteries) and additional stent diameters (4.5 and 5.0 mm) for the bx velocity with hepacoat on stent system. The device, as modified, is now indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (= 30 mm in length in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (= 30 mm in length) with reference diameters in the range of 2.25 mm in 4.00 mm. The 2.25 mm, 2.50 mm, and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.
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