TVA Medical today released data from a meta-analysis study of its everlinQ endovascular arteriovenous fistula system designed for hemodialysis access, touting a high procedure success rate and a high rate of fistula maturation.
Results from the 236-patient trial were presented at the Leipzig Interventional Course 2018, the Austin, Texas-based company said.
Data in the meta-analysis came from four clinical studies and 79 commercial cases, and indicated a 96.8% and 97.8% procedure success rate in clinical studies and real-world cases, respectively, as well as an acceptable safety profile.
The results also indicated 88% fistula maturation at three months among subjects from clinical studies and that 74.8% of the patients from the study population and 90% of patients in real-world cases were successfully cannulated by six months.
Kaplan-Meier estimates from the meta-analysis indicated a 74.8% primary patency rate at 12 months in clinical study patients, a 79% secondary patency rate at 12 months in clinical study patients and a 98.2% functional patency at 12 months in clinical study patients.a.
“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. Tobias Steinke of Düsseldorf, Germany’s Schoen Hospital said in prepared remarks.
“I am very pleased with the utility and patient outcomes I’ve experienced to date with the new 4 Fr everlinQ endoAVF System,” said Dr. Jones. “I am excited to have an endovascular option to offer patients,” Dr. Robert Jones of Birmingham, England’s Queen Elizabeth Hospital said in a press release.
Last September, TVA Medical said it won CE Mark approval in the European Union for its EverlinQ 4 endoAVF system designed for creating hemodialysis access using an endovascular approach.