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A couple weeks ago TVA Medical, Inc.'s everlinQ System won the 2014 Best Start-Up Innovation Award from Innovations in Cardiovascular Interventions. It received the top international honor and was chosen from over 80 international companies.
DOTmed News, had the opportunity to speak with Dr. William E. Cohn, co-founder of TVA Medical, professor of surgery at Baylor College of
Medicine, cardiac surgeon and director of the Center for Technology and
Innovation at Texas Heart Institute, about this new minimally-invasive therapy for renal disease.
DOTmed News: Can you discuss how the everlinQ System works and what benefits it can bring to chronic kidney disease patients?
William E. Cohn: The everlinQTM system from TVA Medical is an investigational medical technology that is designed to create an arteriovenous fistula (AVF) without the need for open surgery. An AVF provides a means by which a patient with renal failure can be connected tothe hemodialysis machine.
In the everlinQ procedure, two thin, flexible magnetic catheters are inserted into an artery and vein in the arm. A small burst of radiofrequency energy is used to create a connection between the artery and vein to create the fistula after which the catheters are removed. The AVF results in dilation of arm veins providing reproducible vascular access in the dialysis clinic.
Creating an AVF percutaneously using the everlinQ system has the potential to be less invasive than traditional AVF surgery, reduce infection risk, reduce patient discomfort, reduce recovery times, and most importantly, improve fistula quality and durability.
DOTmed News: Does the system also have the potential to bring cost savings to hospitals? If so, can you give us some idea of the percentages or amounts of savings possible?
WEC: The everlinQ system absolutely has the potential to reduce health care costs. To constitute a meaningful advance in the current environment, new medical technology must improve patient outcome as well as decrease resource utilization. We think this technology will do both.
We know that surgical AVFs have high failure rates, leading to patient complications and need for repeat procedures to maintain function. On average, patients receiving surgical AFVs require two to three additional procedures to maintain vascular access.
The annual cost to the U.S. health care system of managing dysfunctional vascular access exceeds $3 billion annually. These additional procedures result in delays of five to 12 months during which hemodialysis must be delivered through transcutaneous catheters, which are associated with high risk of serious infection and death, and higher resource utilization