Medtronic’s Talent approved for AAA
This article was originally published in The Gray Sheet
Executive Summary
Medtronic gains PMA approval April 15 for its Talent endovascular stent graft with CoilTrac delivery system for the minimally invasive treatment of abdominal aortic aneurysms. The device is indicated for aneurysms with aortic neck diameters of up to 32 mm and proximal aortic neck lengths as small as 10 mm. Medtronic believes that the device will expand by about 20% the AAA population treatable via an endovascular approach, since currently available systems are indicated for smaller aortic neck diameters and longer aortic neck lengths. Talent will complement Medtronic's AneuRx AAAdvantage abdominal stent graft, which is for diameters of up to 26 mm and lengths of 15 mm or more. Medtronic submitted the Talent PMA last November (1"The Gray Sheet" Dec. 10, 2007, p. 6)