Medtronic points at two clinical studies, new results from which suggest that the company’s Endurant AAA stent graft system for endovascular repair of abdominal aortic aneurysms, continues to deliver durable, consistent and proven outcomes.
Medtronic says its Endurant AAA stent graft system has been used to treat more than 165,000 patients worldwide since it was initially introduced in Europe in 2008. This makes it the numerical leader of the pack, being selected for nearly one of every two endovascular procedures to repair abdominal aortic aneurysms around the world.
So to the newly touted data, which reflect mid-term performance from a U.S. IDE study of 150 patients (with strict eligibility criteria) at 26 centers that led to the device’s approval by the U.S. FDA in 2011 and an international study, called the ENGAGE registry, that was initiated after receipt of the CE mark in 2008. This study had fewer exclusion criteria and a greater population (>1200 patients at 79 sites across six continents). This study population consequently had more complex baseline characteristics, including 17.8 percent whose AAA features placed them outside the device’s instructions for use.
Four-year follow-up for all 150 patients enrolled in the U.S. IDE study and for the first 500 patients enrolled in the international ENGAGE registry has been completed. Three-year follow-up for all 1,263 patients in the ENGAGE registry has been completed. Outcomes for these three patient cohorts were presented in November at two different medical meetings — VIVA (in Las Vegas) and VEITH symposium (in New York):
- Four-year results for all 150 patients in the U.S. IDE study include a 99.2 percent rate of freedom from aneurysm-related mortality and a 90.0 percent rate of freedom from secondary intervention. In addition, 98.0 percent of the patients’ aneurysm sacs were stable or had decreased in diameter by more than 5 mm at four years of follow-up. At four years, none of the patients (0 percent) had experienced a type I/III endoleak or a main body migration.
- Four-year results for the first 500 patients in the ENGAGE registry are remarkably consistent with those for all patients in the U.S. IDE study, despite the differences in eligibility criteria and baseline characteristics. They include a 98.4 percent rate of freedom from aneurysm-related mortality, and an 87.3 percent rate of freedom from secondary intervention.
- Three-year results for all 1,263 patients in the ENGAGE registry include a 98.5 percent rate of freedom from aneurysm-related mortality and an 89.5 percent rate of freedom from secondary intervention. In addition, 91.0 percent of the patients’ aneurysm sacs were stable or had decreased in diameter by more than 5 mm at three years of follow-up. At three years, type I/III endoleaks had occurred in 1.5 percent of the patients; and main body migration, in none (0 percent).
“Aneurysm-related mortality, secondary interventions and changes in sac diameter are three critically important measures of stent graft performance,” said Dr. Edward Woo, director of the MedStar Regional Vascular Program, and chairman of vascular surgery and professor of surgery at Georgetown University in Washington, D.C. “Judging from the latest results from two high-quality studies, the impressive performance of the Endurant stent graft system has proven to be remarkably durable and consistent on these and other important measures across a wide range of patients and operators.”
Source: Medtronic, Inc.