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news.New England Research Institutes has announced that its statistical analysis of data in the Lifeline Registry of Endovascular Aneurysm Repair contributed to the recent FDA approval of Medtronic's Talent abdominal stent graft.
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New England Research Institutes (NERI) said that its assessment of the outcomes in the treatment of abdominal aortic aneurysms demonstrated that the Talent abdominal stent graft’s primary safety endpoints were statistically superior compared to open surgery.
Medtronic’s Talent abdominal stent graft is designed to treat bulges in the aorta which can result in a deadly rupture if left untreated.
Simona Zannetti, senior director of clinical research at Medtronic endovascular innovation business, said: “Strategically, NERI played a significant role in helping us achieve FDA approval and expanding our aortic stent graft product line. NERI’s contribution to the statistical analysis plan and clinical study report were key in characterizing safety of the Talent abdominal stent graft.”