Findings From Meta-Analysis Presented for TVA Medical's everlinQ endoAVF System
February 7, 2018—TVA Medical, Inc. announced the presentation of an international meta-analysis of clinical experience in patients who received the company's everlinQ endovascular arteriovenous fistula (endoAVF) for hemodialysis access. The study analyzed data from 236 patients with end-stage renal disease (ESRD) at 28 centers in seven countries. The findings were presented by Tobias Steinke, MD, at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany.
The company stated that the everlinQ endoAVF system is designed to create an arteriovenous fistula for hemodialysis access using an endovascular approach. In the procedure, two thin, flexible magnetic catheters 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.
Dr. Steinke commented in the company's announcement, "Our meta-analysis from four clinical studies and real-world experience across three continents supports the use of the everlinQ endoAVF system as a valuable hemodialysis access option without open surgery." Dr. Steinke is Chief of Vascular and Endovascular Surgery at Schoen Hospital in Düsseldorf, Germany.
According to TVA Medical, the meta-analysis included four clinical studies with pooled efficacy and safety data from 157 and 125 patients, respectively, using the 4- or 6-F versions of the everlinQ catheter system. The data also included 79 commercial uses of the 6-F catheter system.
The investigators reported the following results:
- 96.8% and 97.8% procedural success rate in the clinical study population and real-world cases, respectively, with an acceptable safety profile
- 88% fistula maturation at 3 months among evaluable patients from the clinical studies
- 74.8% of patients from the study population and 90% of patients in the real-world cases were successfully cannulated by 6 months
- 74.8% primary patency, 79% secondary patency, and 98.2% functional patency by Kaplan-Meier estimates in the clinical study patients at 12 months
Also at LINC 2018, Robert Jones, MD, consultant interventional radiologist at Queen Elizabeth Hospital in Birmingham, England, presented a patient case he performed using the everlinQ 4 endoAVF system, which received European CE Mark approval in 2017. The device uses a 4-F catheter system to create an endovascular fistula. Dr. Jones commented, "I am very pleased with the utility and patient outcomes I've experienced to date with the new 4-F everlinQ endoAVF system. I am excited to have an endovascular option to offer patients."
The everlinQ endoAVF system with 4- and 6-F catheter systems received European CE Mark approval and Health Canada Medical Device License for ESRD patients. It is not available for sale in the United States and is currently under review by the US Food and Drug Administration, advised TVA Medical.