Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Analysis, Inspection and Laboratory
LeftNav
Assisted/Independent Living
LeftNav
Clinical and Nursing Equipment
LeftNav
Design and Manufacture of Medical Equipment
LeftNav
Diagnostics Equipment, Monitoring and Test
LeftNav
Education, Training and Professional Services
LeftNav
Health Education and Patient Management
LeftNav
Health Estates Management
LeftNav
Healthcare Support and Information Services
LeftNav
Hygiene and Infection Control
LeftNav
IT and Communications in Healthcare
LeftNav
Materials
LeftNav
Medical Device Technology
LeftNav
Research and Development
LeftNav
Safety and Security
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone
 
 
News

Medtronic's Endurant II AAA stent graft system receives CE Mark

Medtronic : 18 January, 2012  (New Product)
Medtronic receives the CE mark for the Endurant II AAA Stent Graft System and is making the international launch of the system which meaningfully expands the options physicians outside the USA have to treat patients with abdominal aortic aneurysms through a minimally invasive technique called endovascular aortic repair (EVAR).
An abdominal aortic aneurysm (AAA) is a weakening or bulge in the segment of the aorta, the body's main artery, that crosses through the abdomen. AAA is often called a 'silent killer' because it rarely causes apparent symptoms until rupturing, which usually results in the patient's death.



Developed in collaboration with more than 250 physicians from around the world, the new system encompasses the proven clinical performance of the market-leading Endurant stent graft platform, while adding advanced design features that enhance the device’s ease of use.



Now available in most European counties, the Endurant II AAA Stent Graft System carries forward the proven performance of its predecessor, while adding three distinct enhancements to enable both the most straightforward and challenging cases:



Beginning at the point of access, the new lower-profile delivery system - with 35 percent extended hydrophilic coating for enhanced access to challenging anatomies - allows the 28mm-diameter bifurcated segment (the most commonly used size) to fit inside an 18 French OD (outer diameter) catheter (down from 20 French with the original device).



Second, the addition of two new contralateral limb lengths (156mm and 199mm) enables more configuration options requiring fewer total pieces.



Finally, the radiopacity of the distal end of the bifurcated segmen's contralateral gate has been improved to enhance visibility and aid with limb insertion, placement and deployment.



"The Endurant II AAA
Stent Graft System will confer considerable confidence to vascular surgeons who use EVAR to treat even the most complex AAAs," said Prof Hence Verhagen, Chief of Vascular Surgery at the Erasmus Medical Center in Rotterdam, the Netherlands. "Building on the exceptional clinical outcomes of the original system, which has significantly increased the applicability of EVAR, Endurant II offers an even better user experience which will benefit even more patients whose AAAs are detected before rupturing."



Prof Verhagen, who led the European clinical trial of the original Endurant
Stent Graft that contributed to that device's approval, was the first physician to successfully use the new system since it received the CE mark.



In countries where the Endurant II
Stent Graft is approved with the CE mark, the device is indicated for the endovascular treatment of abdominal aortic aneurysms in patients with a proximal neck ≥ 10 mm in length with ≤ 60 degrees infrarenal and ≤ 45 degrees suprarenal angulation and in patients with a proximal aortic neck ≥ 15 mm in length with ≤ 75 degrees infrarenal and ≤ 60 degrees suprarenal angulation.



In the United States, the Endurant II AAA
Stent Graft System is expected to receive approval from the US Food and Drug Administration (FDA) during 2012. The original Endurant AAA Stent Graft System received FDA approval in December 2010 and quickly became the US market leader.



In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProHealthServiceZone.com
Netgains Logo