Medtronic (NYSE:MDT) said data from a pair of clinical trials evaluating its Endurant stent graft for abdominal aortic aneurysms "affirm the Endurant stent graft’s durable, consistent and proven outcomes."
The data, from the independent Pandora study and the Medtronic-sponsored Engage trial, showed low rates of "aneurysm-related" mortality, reintervention, stent graft migration and conversion to open surgery, according to a press release.
The 273-patient Pandora trial, an "all-comers" study, met its primary endpoint of reintervention in 9.5% of cases over a median period of more than 3½ years, according to the release. Secondary endpoints for proximal migration (0%), Type I/III endoleaks (2%) and AAA-related death (0.3%) were also met, Medtronic said.
"The findings of this independently executed study are consistent with those published from Engage, the largest contemporary postmarket study on a single stent graft," Dr. Giovanni Torsello, who presented the data at the 2014 Charing Cross international symposium in London, said in prepared remarks. "The long-term data reinforce the clinical leadership of the Endurant stent graft in an all-comer patient population."
The Engage data, presented at Charing Cross by Dr. Hence Verhagen, concerned a sub-set of patients with aneurysms of a certain "neck length" – or the span of healthy aortic tissue between the aneurysm and the lowest renal artery, according to the release.
Patients with neck lengths of 10mm to 15mm and 15mm or greater showed " similarly strong outcomes," Medtronic said. Analysis of 48 patients with shorter neck lengths, 79 with medium neck length and 364 patients with long neck lengths showed "no statistically significant differences" across the 3 groups, the company said. That included rates of aneurysm rupture, conversion to open surgery, secondary endovascular procedures and stent graft migration, Fridley, Minn.-based Medtronic said.
"The Endurant stent graft has opened up standard [endovascular aortic repair] to patients who were previously considered ineligible, and the Engage results support the usage of this device in patients with short necks (10mm and up)," Verhagen said in a statement. "The data also show that the Endurant stent graft successfully broadens patient eligibility for standard EVAR."
