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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