Bard FLAIR Endovascular Stent Graft more effective than balloon angioplasty for failing dialysis grafts

Feb 11 2010

C. R. Bard, Inc. (NYSE: BCR) today announced the publication of trial results by The New England Journal of Medicine (NEJM) 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 U.S. Food and Drug Administration 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.”

Timothy M. Ring, chairman and chief executive officer, commented, “The publication of the FLAIR® trial in The New England Journal of Medicine speaks to the rigor of the trial, the relevance of the resultant data and the impact this technology could have on the care of hemodialysis patients. It also has important implications for the healthcare system as our aging population intersects with increasing pressure to control costs and the desire for better evidence-based medicine.”