Medtronic's Endurant AAA Stent Graft Delivers Durable Outcomes for Abdominal Aortic Aneursym Repair

2012-11-19 19:02:40 -
Two-Year Clinical Data Presented at VEITHsymposium Demonstrate Consistently
Strong Performance Worldwide in Pre- and Post-Market Evaluations of Innovative
Medical Device

MINNEAPOLIS -- Nov. 19, 2012 -- Chosen for nearly one out of every two
endovascular abdominal aortic aneurysm repairs worldwide, the Endurant AAA stent
graft system from Medtronic, Inc. (NYSE: MDT) continues to show robust results
in mid-term follow-up, according to two-year clinical data presented at
VEITHsymposium, which concluded yesterday in New York.

The latest evidence on the market-leading stent graft comes from two clinical
evaluations with two years of patient follow-up -- the U.S. investigational
device exemption (IDE) study and the international ENGAGE registry, the largest
collection of data on any single commercially available stent graft.

The U.S. IDE study of the Endurant system enrolled 150 patients at 26 U.S.
centers and 
  
    
      
        

	    
  
  led to the device's approval by the U.S. Food and Drug
Administration (FDA) in December 2010. The international ENGAGE registry has
enrolled more than 1,200 patients at more than 80 sites across six continents
since the Endurant system received the CE (Conformité Européenne) mark in June
2008.

"It's reaffirming to see that the two-year data from the international ENGAGE
registry and the U.S. IDE study are similar to what we saw at one year, which
indicates that the Endurant AAA stent graft continues to perform well in a
variety of geographic locations and patient anatomies," said ENGAGE investigator
Dittmar Bockler, MD, PhD, of the University Hospital of Heidelberg in Germany,
who shared these results at VEITHsymposium on Saturday. "The Endurant system
sets a new standard in clinical outcomes for aortic stent grafts with
unprecedented breadth, depth, quality and consistency of results."

International ENGAGE Registry
Two-year results on 500 patients from the international ENGAGE registry showed
that more than 98 percent (490 patients) were free from aneurysm-related
mortality through two years of post-procedure follow-up. The Type I/III endoleak
rate was low (1.1 percent) for this real-world patient population, with more
than half (56 percent) of the aneurysm diameters among these 500 patients
showing a reduction in size of 5 mm or more.

U.S. IDE Study
Demonstrating similar safety and efficacy, two-year results on all 150 patients
from the U.S. IDE study showed 100 percent freedom from aneurysm-related
mortality. Additionally, the Type I/III endoleak rate was low (0.8 percent),
with more than three-fifths (62 percent) of the aneurysm diameters decreasing by
at least 5 mm.

                 Two-Year Outomes with Endurant AAA Stent Graft

+-----------------------------+------------------+------------------+
| Notable Clinical Endpoints  | ENGAGE Registry  |  U.S. IDE Study  |
|                             | (N=500 Patients) | (N=150 Patients) |
+-----------------------------+------------------+------------------+
| Freedom from ARM*           |      98.1%       |       100%       |
+-----------------------------+------------------+------------------+
| Type I/III Endoleak         |       1.1%       |       0.8%       |
+-----------------------------+------------------+------------------+
| Aneurysm Diameter Reduction |       56%        |       62%        |
+-----------------------------+------------------+------------------+
* Aneurysm-related mortality (ARM) is defined as death from rupture or from any
procedure intended to treat the aneurysm.

Now in its fourth decade, VEITHsymposium provides vascular surgeons,
interventional radiologists, interventional cardiologists and other vascular
specialists with a unique and exciting format to learn the most current
information about what is new and important in the treatment of vascular
disease.

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. The company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers around the
world.

ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology -- alleviating pain, restoring health and extending
life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
results.

                                    - end -


Contacts:
Joe McGrath
Public Relations
+1-707-591-7367

Jeff Warren
Investor Relations
+1-763-505-2696




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Source: Medtronic, Inc. via Thomson Reuters ONE
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