CR Bard, a developer, manufacturer and marketer of life-enhancing medical technologies, has reported the publication of trial results by The New England Journal of Medicine (NEJM) which demonstrated that the Bard Flair Endovascular Stent Graft maintains the patency of dialysis access grafts effectively than balloon angioplasty alone.
The Flair Endovascular Stent Graft is the interventional implant technology approved by the FDA for use in the treatment of stenoses at the venous anastomosis of ePTFE or other synthetic Prosthetic arteriovenous (AV) grafts.
In the prospective, randomized, controlled, multi-center trial, 190 patients who required treatment for failing AV grafts received either balloon angioplasty alone or balloon angioplasty and a Flair Endovascular Stent Graft.
In the trial, at six months, the treatment area of patients that received a Flair Endovascular Stent Graft was more than twice as likely to be functioning when compared to patients who received balloon angioplasty alone and at 210 days, the treatment area was far less likely to require additional interventions. Adverse events, patient demographics and clinical variables were statistically equivalent between both groups during the trial.
Ziv Haskal, chief of the vascular and interventional radiology division at the University of Maryland Medical Center in Baltimore and principal investigator, said: “This is a game-changing study. For the first time, clinicians have compelling evidence that we can 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 Ring, chairman and chief executive officer, said: “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 implications for the healthcare system as our aging population intersects with increasing pressure to control costs and the desire for better evidence-based medicine.”