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Medtronic Releases Five-Year Clinical Data for AneuRx(R) Stent Graft System

Posted on: Tuesday, 2 October 2007, 09:01 CDT

Medtronic, Inc. (NYSE:MDT), today announced the release of its fourth edition of the AneuRx® Clinical Update, representing the largest collection of clinical data available for any commercially approved endograft, including more than 1,000 patients in its clinical trial and 70,000 implants since 1996. The Clinical Update is being distributed to more than 18,000 physicians worldwide as an insert in the September 2007 issue of Endovascular Today magazine and is also online at www.medtronic.com/physician/AneuRx.

"This report provides vascular surgeons with an in-depth analysis of the long-term safety and efficacy data on the AneuRx Stent Graft," said Dr. Rodney White, Vascular Surgery Division chief, Harbor-UCLA Medical Center. Dr. White's clinical experience with the device includes more than 10 years of patient follow-up. "Medtronic should be commended for its ongoing commitment to tracking patient outcomes and device performance."

A principal component of the Clinical Update is newly released long-term data from the AneuRx IDE Clinical Trial, a study which included 1,193 patients treated with an early generation of the AneuRx device. Of the more than 600 patients in the trial at five years of follow-up, 96.0 percent were free from an aneurysm-related death at five years. In collaboration with FDA, Medtronic also analyzed aneurysm-related death using a broader FDA definition, and the analysis showed a freedom from aneurysm-related death at five years of 94.6 percent. Between four and five years of follow-up, there was an observed increase in aneurysm-related death. Factors that were associated with late aneurysm-related death include, but are not limited to, poor follow-up, patients refusing treatment, and an elderly patient population. These data show the continued safety and efficacy of this device, taking into consideration early generation endograft designs, the physician learning curve for implantation technique, and liberal patient selection criteria.

In addition to the updated IDE clinical trial results, Medtronic also reports on the AneuRx Post-Market Surveillance Registry and the Lifeline Registry of Endovascular Aneurysm Repair, both of which provide contemporary, real-world usage data on the AneuRx Stent Graft. In the Post-Market Surveillance Registry, patients experienced freedom from aneurysm rupture of 99.0 percent at three years and freedom from surgical conversion of 96.0 percent at three years. The incidence of migration in both registries consisted of a single report of migration out of a patient cohort of 334, representing a migration rate of 0.3 percent at three years.

Several other key areas highlighted in the Clinical Update include information on endoleaks, migration, and the related importance of appropriate patient follow up. As with all devices used in endovascular aneurysm repair, patient follow-up compliance is critical for successful long-term outcomes.

Medtronic has continued its leadership in the field of endovascular AAA therapy with its newest innovation, the AneuRx AAAdvantage Stent Graft system. Building on the solid foundation of the AneuRx Stent Graft, this next generation technology features enhancements for ease of use, patient applicability, and accuracy of stent graft delivery.

"Medtronic appreciates the partnership that it has had during the last 11 years with clinical investigators and physician implanters, who have contributed to improvements in implantation techniques and proper patient selection, as well as enhancements in the technology in order to advance AAA EVAR therapies and optimize patient outcomes," said Katie Szyman, vice president and general manager of the Endovascular Innovations business at Medtronic. "We are committed to tracking the performance of our endografts and to providing physicians with the latest clinical data and information to optimize care of their patients."

Endografts are stent-like devices used to treat Abdominal Aortic Aneurysms (AAAs), a ballooning of the aorta which can be fatal if untreated. The alternative to endografts is open surgical repair, which carries a mortality rate of 3 to 5 percent at 30 days post-procedure.

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 Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.

Source: Business Wire

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