TVA Medical, Inc., today announced promising results from a clinical study evaluating a novel hemodialysis access technique that has the potential to revolutionize vascular access for patients with chronic kidney disease without the use of traditional open surgery.
The clinical results of TVA Medical's everlinQTM System were published online this week in the April 2015 issue of Journal of Vascular and Interventional Radiology.
The FLEX study evaluated the safety and efficacy of TVA Medical's everlinQ System to create an arteriovenous fistula (AVF) in a percutaneous procedure for patients with chronic kidney disease. The everlinQ System has been studied outside the United States and has received CE mark. The product is not currently available in the United States and has not been evaluated by the United States Food and Drug Administration.
Of 33 study patients, technical procedural success was achieved in 97 percent of cases, and 96 percent of study patients had a usable and unobstructed (patent) AVF at six months, with minimal need for additional intervention. The average time to a usable AVF for hemodialysis was 58 days.
"The results demonstrate that the everlinQ System can create AVFs that are usable for dialysis and resist closure," said Dheeraj Rajan, M.D.,an investigator of the FLEX study and Head of Vascular and Interventional Radiology at University of Toronto, Canada. "I am optimistic as we continue to study the impact the product has oninfections, patient discomfort, the need for additional interventions, and healthcare costs."
Worldwide more than 2 million patients with end-stage renal disease receive hemodialysis therapy and require vascular access to connect to a dialysis machine. Surgical AV fistulas are the standard approach to achieve vascular access. AV fistulas have high failure rates, often as high as 60 percent, and require frequent revisions, resulting in increased morbidity and unnecessary costs.
Patients receiving surgical AVFs require an average of two to three additional interventions to achieve and maintain a usable fistula, which can delay availability of the AVF for hemodialysis by five to 12 months. In addition to common surgical AVF complications, the cost to the healthcare system of managing dysfunctional vascular access is high – estimated at approximately $2.9 billion annually in the United States alone. Currently there are no percutaneous AV fistula hemodialysis access methods approved for commercial use by United States Food and Drug Administration.
"Millions of chronic kidney disease patients rely on hemodialysis therapy to stay alive and there is a major unmet need for a simpler and more effective means to provide them with vascular access." said Adam L. Berman, CEO of TVA Medical. "We remain dedicated to building clinical evidence to document the potential benefit of everlinQ for dialysis patients."