DevicePMAs@therightstef:P970035_S000 JSONTXT 11 Projects

Approval for the AVE Micro Stent(TM) II Over-the-Wire Coronary Stent System and the AVE GFX(TM) Over-the-Wire Coronary Stent System. The devices are indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length < 30 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm. Stenting is intended to improve coronary luminal diameter (see Individualization of Treatment). Long term outcome (beyond 6 months) for this permanent implant is unknown at present.