Medtronic Files PMA For Talent Abdominal Stent Graft System
This article was originally published in The Gray Sheet
Executive Summary
A modular PMA for Medtronic's Talent stent graft for minimally invasive treatment of abdominal aortic aneurysms is now complete and has been deemed "fileable" by FDA, according to the company
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Medtronic’s Talent approved for AAA
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)
Medtronic’s Talent approved for AAA
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)
New Products In Brief
New AneuRx delivery system: Medtronic launches Jan. 10 its AneurX AAAdvantage endovascular stent graft on a new delivery system called Xcelerant Hydro. Compared with the previous Xcelerant system with which AneuRx AAAdvantage launched in the U.S. in March 2006, Xcelerant Hydro has a hydrophilic coating to reduce friction and facilitate navigation of small and tortuous arteries. Medtronic completed a PMA submission for another abdominal aortic aneurysm stent graft, Talent Abdominal, in November (1"The Gray Sheet" Dec. 10, 2007, p. 6). That device's delivery system is called CoilTrac