DevicePMAs@therightstef:P070027_S011 JSONTXT 11 Projects

Approval for adding the talent converter stent graft and talent occluder asline extensions to the already existing talent abdominal product family. the device, as modified, will be marketed under the trade name talent converter stent graft system withxcelerant hydro delivery system & talent occluder with occluder delivery system. the talent converter is indicated for secondary endovascular intervention in patients having received prior endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms using the talentor aneurx bifurcated stent grafts in which there is inadequate proximal fixation, seal, overlapping of modular components or unattainable contralateral limb cannulation. the talent occluder is indicated for endoluminal occlusion of the common iliac artery in order to preventretrograde blood into the aneurysm sac when used in conjunction to a fem-fem bypass.