TVA Medical Receives CE Mark For Next-Generation everlinQ™ 4 endoAVF System
4 French catheter system creates an endovascular hemodialysis access with a streamlined procedure
AUSTIN, Texas, Sept. 27, 2017 /PRNewswire/ -- TVA Medical, Inc., a medical device company developing innovative therapies for end-stage renal disease (ESRD), today announced that its everlinQ™ 4 endoAVF System has received CE Mark in the European Union. The technology uses a 4 French catheter system with enhanced visual indicators to create hemodialysis access using an endovascular technique without open surgery.
In a prospective, single arm, single-center study evaluating the everlinQ™ 4 endoAVF System, 97 percent of endovascular AVF (endoAVF) procedures were successful, and fistula maturation was achieved in 83 percent of patients.
Dr. Tobias Steinke, Chief of Vascular and Endovascular Surgery, Schön Klinik, Düsseldorf, Germany, performed the first case in Europe using the everlinQ 4 System. "The new system with smaller profile catheters and radiopaque visual indicators was extremely easy to use," he said. "This new approach streamlines the procedure for providing patients a functional AV fistula without open surgery."
Each year approximately 3 million people worldwide with ESRD are treated with hemodialysis.1 However, the first step, creating a viable access in the arm, is often a significant clinical challenge. The current standard approach, surgical arteriovenous fistulas (AVFs), are associated with high failure rates2, and may require frequent revisions, impacting patient quality of life and resulting in unnecessary costs.3
"We are pleased to achieve this next regulatory milestone that broadens availability of the everlinQ endoAVF System for patients," said Adam L. Berman, president and CEO of TVA Medical. "We are now offering the 4 French catheter system in Europe, as well as in the everlinQ endoAVF EU Study, which is gathering additional clinical data to support future clinician education, patient access, and reimbursement of the everlinQ endoAVF System."
About the everlinQ endoAVF System
The everlinQ endoAVF System, using the 4 Fr or 6 Fr catheter system, is designed to create an AVF for hemodialysis access using an endovascular approach. In the procedure, two thin, flexible magnetic catheters are inserted into an artery and vein in the arm. A small amount of radiofrequency energy is used to connect the artery and vein to create the fistula. The catheters are then removed and a brachial vein is coil-embolized, enabling future dialysis.
The 6 French everlinQ endoAVF System previously received CE marking for ESRD patients who need hemodialysis. The 6 French system also has Health Canada Medical Device License. TVA Medical is pursuing US FDA clearance of the everlinQ endoAVF System and the technology is not currently available for use in the United States.
About TVA Medical
TVA Medical, Inc., headquartered in Austin, Texas, is developing minimally invasive therapies for end-stage renal disease and other potential applications, such as peripheral vascular disease. More information is available at www.TVAMedical.com
1 Liyanage, et al. Lancet, 2015. 10.1016/S0140-6736
2 Al-jaishi, et al. Am J Kidney Dis 2014;63:464-78.
3 Lok. Clin J Am Soc Nephrol 2: 1043-1053, 2007.
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