News | February 11, 2010

Trial Shows Stent Graft’s Superiority to Balloon Angioplasty for Failing Dialysis Grafts

FLAIR endovascular stent graft

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.”

For more information: www.crbard.com

Related Content

Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Scientists Show How Cells React to Injury From Open-Heart Surgery
News | Cardiovascular Surgery | May 04, 2017
Cedars-Sinai Heart Institute investigators have learned how cardiac muscle cells react to a certain type of injury that...
ERACS Session Highlights Need for Standardized Best Practices in Cardiac Surgery
News | Cardiovascular Surgery | May 02, 2017
The recently formed group Enhanced Recovery After Cardiac Surgery (ERACS) hosted an organizing session in Boston on...
ClearFlow Receives Frost & Sullivan New Product Innovation Award for PleuraFlow Technology
News | Cardiovascular Surgery | May 01, 2017
ClearFlow Inc. has received the prestigious 2017 Global Frost & Sullivan Award for New Product Innovation. The...
Overlay Init