Thursday, September 28, 2017
TVA Medical, Inc., a medical device company developing innovative therapies for end-stage renal disease (ESRD), today announced that its everlinQTM 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 rates, and may require frequent revisions, impacting patient quality of life and resulting in unnecessary costs.
"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."
