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Four Year Data for Medtronic's Endurant AAA Stent Graft Shows Durable, Consistent Outcomes in Real-World Setting
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Medtronic's Endurant AAA Stent Graft
Medtronic's Endurant AAA Stent Graft
November 30, 2015 -- Long-term data of Medtronic's Endurant AAA stent graft system in a real-world population, including patients with challenging AAA neck anatomies, historically associated with higher rates of adverse events, reinforce earlier outcomes and demonstrate lasting and consistent results for the endovascular repair of abdominal aortic aneurysms (EVAR).

This new data from the global ENGAGE registry were presented by Dr. J.M. Verhagen of Erasmus University Medical Center in Rotterdam at this year's VEITH Symposium in New York, the premier annual conference in the field of vascular surgery.

These data demonstrated:

  • No significant differences between short and standard neck cohorts in type 1a endoleak rate and AAA diameter increase;
  • Low rates of aneurysm rupture and conversion to open surgery;
  • No significant difference between cohorts for secondary endovascular procedures;
  • 99.2% freedom from aneurysm-related mortality for the short neck cohort vs. 98.3% for standard length necks

The ENGAGE registry, which plans to follow-up all patients for ten years, represents the most robust post-market registry ever initiated, including more than 1,200 patients at 79 sites across six continents.

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The 1st AAA Endovascular Repair (EVAR)

First performed in 1990, endovascular repair of abdominal aortic aneurysms, a less invasive method for repairing the major blood vessel in the body, has advanced significantly as a treatment for this dangerous condition.

With advances in device design and procedural improvements, usage among vascular surgeons has increased to the point that it is competitive and even preferred over the previous standard of open surgical repair. This is regularly a matter of debate at the annual VEITH symposium and 2015 was no exception. (Read Caitlin Cox's report on TCTMD for details of this year's discussions.)

Yet it is important to remember that the initial reaction to the EVAR procedue was that it was "crazy" and even dangerous.

To appreciate how much this field of vascular surgery has changed, and the barriers that physicians have had to overcome, watch the above video, which relates the story of the first endovascular AAA repairs, told by the surgeons who did them: Drs. Juan Parodi, Frank Veith and Michael Marin.

A press release from Medtronic, Inc. follows:

Medtronic's Endurant AAA Stent Graft Delivers Durable, Consistent and Proven Outcomes at Four Years in Real-World Setting
Four-Year Subset Analysis from Global ENGAGE Registry Demonstrates Positive Outcomes in Challenging Anatomies

November 17, 2015 -- Dublin and New York City -- Selected for nearly one of every two endovascular abdominal aortic aneurysm (AAA) repairs globally, the Endurant® AAA stent graft system from Medtronic plc (NYSE: MDT) continues to maintain durable and consistent outcomes at four years in real world settings, including challenging anatomies. Hence J.M. Verhagen, M.D., Ph.D., Professor and Chief of Vascular Surgery, Erasmus University Medical Center in Rotterdam, the Netherlands, presented on the market - leading stent graft on the opening day of the VEITHsymposium in New York City.

Patients with challenging anatomy have historically been associated with limited eligibility for endovascular repair and higher rates of adverse events. Dr. Verhagen's presentation focused on results across a range of patient anatomies.

"Analysis of the patient cohort from the four-year global ENGAGE registry included several anatomically challenging sub-groups: short, highly angulated, and calcium/thrombus burdened AAA necks. These mid-term outcomes offer clinical insight into the treatment of AAA neck anatomies relevant and applicable to current clinical practice and real world settings," said Prof. Verhagen.

At four-years, no significant differences were found between the short neck (>=10-<15mm) and standard neck (>=15mm) cohorts in terms of type Ia endoleak rate and AAA diameter increase. Low rates of aneurysm rupture and conversion to open surgery were demonstrated through four-year follow-up, and there was no significant difference between the cohorts in terms of secondary endovascular procedures. Freedom from aneurysm-related mortality (ARM) at four-years was 99.2 percent for the short neck cohort and 98.3 percent for the standard length necks.

The Endurant stent graft system is approved outside of the U.S. for use in patients with AAA neck lengths >=10 mm and <=60° infra-renal angulation and >=15mm with <=75° infra-renal angulation. In the U.S., the Endurant stent graft system is indicated for necks >=10 mm and <=60° infra-renal angulation.

The Endurant system received the CE (Conformité Européenne) mark in June 2008, and since that time the global ENGAGE registry has enrolled more than 1,200 patients at 79 sites across six continents. U.S. Food and Drug Administration (FDA) approval was received in December 2010. With ten-year follow-up planned for all patients, the ENGAGE registry represents the most robust post-market registry ever initiated.

Marc R.H.M. van Sambeek, M.D., Ph.D., Department of Vascular Surgery, Catharina Hospital, Eindhoven, the Netherlands, will report on the four-year full cohort analysis from the global ENGAGE registry on Saturday, November 21.

"The global ENGAGE registry demonstrates Medtronic's unmatched commitment to clinical research on endovascular aneurysm repair (EVAR)," said Daveen Chopra, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "Through dedication to clinical data and innovation in technology, we hope to expand EVAR treatments to previously untreatable patient populations."

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 VEITHsymposium
Now in its 42nd year, 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. The five day event features rapid-fire presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. For more information, please visit or contact Pauline T. Mayer at 631.979.3780.

About Medtronic
Medtronic plc (, headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 85,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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.

Reported by Burt Cohen, November 30, 2015