Medtronic ($MDT) just released new long-term clinical data from two larger-scale postmarketing studies for its Endurant stent graft system, which is designed to treat abdominal aortic aneurysms. The news is good, and the positive postmarketing trial results are a crucial win for the company in its bid to maintain momentum for the product's sales and reputation.
The U.S. IDE study showed that all 150 patients involved in the trial had no aneurysm-related deaths after two years. Patients also had an extremely low rate of stent graft leakage, and a majority of patients (62%) saw their aneurysms decline at least 5 mm in size.
Similarly, 98% of the 500 patients who took part in the international ENGAGE registry experienced no aneurysm-related deaths two years after the procedure. For this group, stent graft leakage was also quite low.
Endurant AAA gained FDA approval in late 2010. The next-generation version, the Endurant II, gained a CE mark in December 2011 and rolled out in the U.S. over the summer, following the FDA's nod earlier this year.
The new Endurant AAA data, presented at VEITHsymposium in New York, is good news for Medtronic after a mixed fiscal 2013 second quarter in which charges, litigation costs and expenses smacked net profit.
- read the release