A Houston-based company has enrolled the initial subjects in a first-of-its-kind trial.

VenoStent was created to improve vascular surgery outcomes for patients undergoing arteriovenous fistula (AVF) creation surgery.

“When a vein is connected to an artery, as in AVF creation, the vein experiences a 10x increase in pressure and flow that is traumatizing to veins. Many fail to become usable for dialysis,” Geoffrey Lucks, VenoStent COO and co-founder, says in a news release.

Enter VenoStent’s SelfWrap Bioabsorbable Perivascular Wrap, better known as simply SelfWrap. In May 2023, SelfWrap gained FDA approval to begin its US IDE Study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistula Study.

Roughly half a million Americans need hemodialysis just to survive another day. Nearly all of those patients require a vascular access creation surgery, but the procedure has a 50-percent failure rate in its first year. VenoStent and SelfWrap are aimed at improving those odds. It works by using the body’s own healing mechanism.

SelfWrap is a flexible, bioabsorbable vascular wrap that helps to recreate the arterial environment in veins. Over time, the body replaces the SelfWrap with venous tissue.

The company has begun to enroll patients for what will eventually be a 200-subject study. Some of those people have radiocephalic fistulas, others have brachiocephalic ones. This is important, because it will likely prove that the technology works for most types of AVFs. The sites for this clinical trial are at the Surgical Specialists of Charlotte, P.A. in Charlotte, NC, and the Cardiothoracic and Vascular Surgeons in Austin.

“While it’s ambitious and sets a high bar for FDA Approval, we owe it to the chronic kidney disease (CKD) patient community to provide the highest level of clinical evidence,” Timothy Boire, CEO and cofounder, says in the release. “We’re confident based on years of preclinical and clinical data that we’ll demonstrate superiority to standard of care with this breakthrough technology.”

VenoStent recently completed a $16 million Series A, financed by Good Growth Capital and IAG Capital. This is the first-ever randomized controlled trial of a medical device designed to improve outcomes from arteriovenous fistula (AVF) creation surgery in the United States.