Trial Shows Stent Graft’s Superiority to Balloon Angioplasty for Failing Dialysis Grafts
February 11, 2010 — The New England Journal of Medicine (NEJM) published results showing the Bard FLAIR Endovascular Stent Graft maintains the patency of dialysis access grafts more effectively than balloon angioplasty alone. The FLAIR Endovascular Stent Graft is the only implant approved by the FDA for use in the treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous access grafts.
The 190 patient randomized trial was the first to demonstrate the superiority of a new therapy over balloon angioplasty. At six months, the treatment area of patients who received a FLAIR stent graft was more than twice as likely to be functioning when compared to patients who received balloon angioplasty alone. Adverse events, patient demographics and clinical variables were statistically equivalent between both groups during the trial.
“This is a game-changing trial,” said Ziv Haskal M.D., chief of the vascular and interventional radiology division at the University of Maryland Medical Center in Baltimore and principal investigator. “For the first time, clinicians have compelling evidence that we can significantly improve outcomes over balloon angioplasty in this underserved and difficult-to-treat patient population. The durable benefit we observed in the trial, as demonstrated by superior patency and freedom from repeat interventions, strongly supports a fundamental change in how we care for hemodialysis patients.”
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