Transformative Vascular Implants Are Starting to Look Less Like Permanent Plumbing and More Like Guided Healing.

Vascular implants live in a harsh world. Blood wants to clot, bacteria wish to surface, and the body never entirely forgets what is “not self.” That shows up as infections, narrowing, thrombosis, and repeat interventions, especially in high-stress settings like dialysis access.

Xeltis, a Netherlands-based medtech, is pursuing a different design goal: a temporary implant that becomes living tissue. The company refers to its approach as Endogenous Tissue Restoration, utilizing an electrospun polymer scaffold designed to support early function. At the same time, the body gradually replaces it with its own tissue over time.

The most concrete proof point so far is the use of hemodialysis access. In September 2025, Xeltis reported positive results from its aXess EU pivotal multicenter trial (120 patients across 18 EU sites), highlighting strong patency and low complications. The company also cited only one infection-related partial explant due to cannulation across the full study population and a bleeding complication rate of less than 0.02 percent across more than 15,000 dialysis sessions.

Regulatory momentum matters here. Xeltis has announced FDA Breakthrough Device Designation for aXess and enrollment of the first patient in its US pivotal trial following IDE approval.

Zooming out, this falls within a broader trend: “biorestorative” implants that aim to reduce the long tail of reinterventions by allowing biology to complete the job. Xeltis is also advancing a coronary bypass conduit program, which includes public updates highlighting patency at 24 months in a prior case and early clinical feasibility reports.

Two open questions feel decisive for the whole category.

First, does tissue restoration stay consistent across patient biology, surgical technique, and real-world sites?

Second, what are the long-term failure modes once the scaffold is gone and only remodeled tissue remains?