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February 9, 2016
TVA Medical's everlinQ endoAVF System Receives Additional Reimbursement in Germany
February 10, 2016—TVA Medical, Inc. announced that its everlinQ endoAVF system, which is designed to create an arteriovenous fistula for hemodialysis using an endovascular approach via catheter-delivered radiofrequency energy, has received NUB (German Neue Untersuchungs und Behandlungsmethoden) status 1 approval. The designation entitles more than 80 of German’s leading hospitals with NUB approval to negotiate with insurance companies for additional funding to cover the cost of the everlinQ device.
The company noted that the approval was granted under the German Institute for the Hospital Remuneration System NUB program for facilitating the introduction of new and innovative medical technologies.
The everlinQ endoAVF received CE Mark approval in 2014. At LINC 2016, the Leipzig Interventional Course, the company announced positive primary endpoint data from a prospective, multicenter clinical study evaluating the everlinQ endoAVF system. TVA Medical will begin controlled commercialization efforts and a postmarket study in Europe this year. The everlinQ endoAVF system is not currently available in the United States and has not been evaluated by the US Food and Drug Administration, advised the company.
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