More than 5 years after Medtronic‘s (NYSE:MDT) Endurant Stent Graft System 1st gained FDA approval, the medical device giant has released data pointing to long-term durability of the treatment for abdominal aortic aneurisms.
Healio reported that Endurant showed durability and safety in patients 5 years after treatment, according to details published in the Journal of Vascular Surgery.
What they found: mortality rates were about 17.7%, and the rates of non-aneurysm-related mortality surpassed 99 percent, Healio noted. Only 1 patient in the assessment suffered from an aneurysm- death after declining treatment for an endoleak and then dying 4 years after the abdominal aortic aneurysm ruptured.
Follow-up addressed patients who took part in Medtronic’s Endurant U.S. investigational device exemption pivotal trial, whose results showed the device was safe and effective.
When it was conducted between June 2008 and April 2009, 150 patients with abdominal aortic aneurysms (AAA) were treated with Endurant at 26 U.S. sites. For the 5-year assessment, researchers obtained clinical follow-up on 94 percent of 101 eligible patients. They also relied on imaging follow-up for 87 percent of patients who participated.
As Healio reported, imaging from those patients was reviewed at 1,6,12,24 and 60 months, and researchers, for regulatory reasons, compared those outcomes with patients from the Medtronic Talent eLPS study.
Beyond the low rate of mortality after 5 years, they determined that 7 of 83 patients had endoleaks at that point (one was of unknown origin). This was based on an evaluation of 83 of 101 patients. Of the total number of patients they looked at, 53 had the maximum diameter of their abdominal aortic aneurysm reduced by more than 5 mm at 5 years. That measure remained stable in 25 patients, but the blockage grew larger by more than 5 mm in 5 patients.
Overall, they found survival rates were better than those produced by the Talent eLPS study.
In April, Minnesota-based Medtronic released data from yet another Endurant study. The Engage global registry study of Endurant touted lowered mortality and rupture rates compared to the earlier Evar 1 trial. Researchers presented data at the 2016 Charing Cross Symposium in London, UK.
