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Home > Press Center > Press Releases from 2005 Annual Meeting > Vascular stent graft system passes safety and efficacy trial

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Jill Goodwin
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Highly favorable preliminary outcomes using the Medtronics Talent ™ Thoracic Stent Graft System in a high-risk/non-surgical population of patients historically managed with “watchful waiting,” were presented in Chicago at the annual meeting of the Society for Vascular Surgery by Ronald M. Fairman, MD, Chief of the Division of Vascular Surgery at the University of Pennsylvania Medical Center, Philadelphia.

According to Fairman, this vascular stent graft system extends the range of treatment options for patients who face life-threatening conditions of the thoracic aorta (the body’s largest artery) such as aneurysms, dissections and trauma. The stent graft is introduced through a small opening in the femoral artery of the leg and is advanced under fluoroscopic guidance to the site of the thoracic aortic aneurysm or dissection, where it is then deployed. Once positioned, the stent expands to the diameter of the aorta, thereby creating a new inner lining for the artery and excluding blood flow from the diseased segment.

The purpose of the prospective, non-randomized, multi-center observational study was to determine the stent graft system’s safety endpoint, as measured by all-cause mortality, and efficacy endpoint, defined as the proportion of patients with successful aneurysm treatment. Secondary 30-day endpoints evaluated the percentage of patients who experienced successful deployment and delivery of the stent graft, death, paraplegia (paralysis of the lower body), secondary procedures required to control stent graft leakage, and any major adverse clinical events (MACE).

Of the 137 patients treated, 59 percent of the patients were male, and the median age was 75 years. A variety of thoracic aortic pathologies were corrected. The mean maximum aneurysm diameter at treatment was 64 mm. and the mean aneurysm length was 108 mm. Procedural success was 98 percent. The 30-day all cause mortality was 7.3 percent (10 patients), and at a median follow-up of 8 months, mortality was 25 percent (35 patients). The paraplegia rate was less than one percent at one month. Fourteen percent of the procedures required a conduit for access. The one-month endoleak rate was 9 percent, and the 8-month rate was 6 percent. The 30-day stroke incidence was 7.3 percent (10 patients). After 8 months, there were no ruptures, late conversions to open surgery, device migration or loss of graft patency. The secondary procedure rate at eight months was 7 percent (9/127). Hospital length of stay averaged nine days.

Fairman said he was pleased with high procedural success and the low rates of operative mortality, stroke incidence and paraplegia in a population of patients who by definition would be considered inoperable. He cautioned, however, that long-term follow up will be required to demonstrate the stent system’s durability and prevention of aneurysm-related mortality.