TVA Medical said today it won CE Mark approval in the European Union for its EverlinQ 4 endoAVF system designed for creating hemodialysis access using an endovascular approach.
The Austin, Texas-based company said the system consists of 2 magnetic catheters which are inserted into an artery and vein in the arm and use a small amount of radiofrequency energy to connect both to create a fistula. The catheters are then removed and the brachial vain is coil-embolized for future dialysis.
“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,” Dr. Tobias Steinke of Düsseldorf, Germany’s Schön Klinik, who performed the 1st case in Europe using the system said.
A prospective, single-arm study of the device reported that 97% of endovascular AVF procedures were sucessful with fistula maturation in 83% of patients.
“We are pleased to achieve this next regulatory milestone that broadens availability of the EverlinQ endoAVF system for patients. 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,” prez & CEO Adam Berman said in a press release.
In October 2015, TVA Medical said it raised $15 million in a Series C financing round to support its everlinQ endoAVF system with strategic investments coming from major players Baxter (NYSE:BAX) and Boston Scientific (NYSE:BSX).