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Product approval

EU approval for TVA Medical’s EverlinQ 4 EndoAVF System

The device is now available in Europe and is being evaluated in the everlinQ endoAVF EU study

TVA Medical has announced that its everlinQ 4 endovascular arteriovenous fistula (endoAVF) system has received CE Mark approval in the European Union. The technology uses a 4F catheter system with visual indicators to create hemodialysis access using an endovascular technique without open surgery in the treatment of patients with end-stage renal disease.

According to the company, a prospective, single arm, single-centre study evaluating the everlinQ 4 endoAVF system demonstrated that 97% of endoAVF procedures were successful, and fistula maturation was achieved in 83% of patients.

“The new system with smaller-profile catheters and radiopaque visual indicators was extremely easy to use. This new approach streamlines the procedure for providing patients a functional AV fistula without open surgery,” said Dr Tobias Steinke, Chief of Vascular and Endovascular Surgery at Schön Klinik in Düsseldorf, Germany, who performed the first case in Europe using the everlinQ 4 system.

The device is now available in Europe and is being evaluated 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.

The procedure uses two thin, flexible magnetic catheters that 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.

TVA Medical noted that the 6F everlinQ endoAVF system previously received CE Mark approval for end-stage renal disease patients who need hemodialysis. The 6F system also has a Health Canada Medical Device License. It is not currently available for use in the US, where the company is pursuing DRA clearance for the technology.