Austin, Texas-based TVA Medical received FDA de novo marketing approval for its everlinQ endoAVF System.
Here are five insights:
1. Using magnetic catheters and radiofrequency energy, the everlinQ endoAVF system creates an arteriovenous fistula for hemodialysis access.
2. The system is designed as an alternative to the current standard vascular access approach, which uses open surgery to create an AVF for dialysis.
3. The FDA approved the system for use in the ulnar artery and ulnar vein to create an endoAVF for hemodialysis in properly indicated patients.
4. In four clinical studies, the everlinQ endoAVF System had 97 percent procedural success, 88 percent fistula maturation at three months, and 75 percent successful cannulation at six months with minimal need for re-intervention.
5. Training on the endovascular fistula creation approach will begin immediately at select U.S. vascular surgery centers, and a post-market study is scheduled to begin this year.