Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

You may also be interested in...



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

Related Content

UsernamePublicRestriction

Register

MT025573

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel