Groundbreaking Implants Create Living Vessels and Valves Made of Patients’ Own, New Healthy Tissue

There is a pressing clinical need in the field of hemodialysis with the number of patients suffering from end-stage kidney disease (ESKD) and requiring hemodialysis rising globally. Current vascular access solutions are fraught with high complication rates. Arteriovenous fistulas (AVFs), though preferred, require a lengthy average maturation time (3.5 months) and demonstrate a low success rate (26% at six months). Arteriovenous grafts (AVGs), often the secondary choice, suffer from lower primary and secondary patency rates and a greater frequency of interventions and complications. Given the shortcomings of existing options, the demand for novel alternatives is evident. Now, an innovative restorative conduit enables the creation of a new, long-term living vessel for hemodialysis vascular access, combining the safety and patency of a fistula with the speed to treatment of an AV graft.

Xeltis (Eindhoven, The Netherlands) is creating transformative implants that enable the natural formation of durable living vessels and valves. The company's endogenous tissue restoration (ETR) platform utilizes a sophisticated polymer implant that encourages the regeneration of the patient’s tissue within and around it, subsequently being absorbed to leave behind new, viable, and lasting vessels and valves. Currently in clinical development by Xeltis is aXessTM, an implantable blood vessel designed for hemodialysis vascular access aiming to overcome the challenges associated with the present options for millions of individuals needing hemodialysis access grafts annually.

The aXess hemodialysis vascular access conduit is an innovative, restorative, bioresorbable implant composed of electrospun supramolecular polymers. Its design and chemical properties facilitate self-healing in the body. Unlike other synthetic materials which may induce a pro-inflammatory response, Xeltis’ biomaterial prompts a pro-healing neo-tissue remodeling response. As this neo-tissue matures, it assumes the functionality of the implant, which gradually absorbs, thus reducing the foreign body reaction typical with non-degradable devices. Over time, the aXess conduit acts as a mechanical and structural scaffold, encouraging tissue cell growth through the body's innate healing mechanisms, ultimately transforming into a living vessel.

Xeltis has announced impressive 12-month outcomes from its initial human (FIH) aXess vascular conduit trial, a single-arm feasibility study in Europe assessing the preliminary safety and effectiveness of the aXess graft in individuals over 18 years with end-stage renal disease who are unsuitable for fistula creation. Regular follow-up visits were scheduled post-procedure, with a five-year follow-up period planned. At the 12-month mark, data from 20 patients implanted with the aXess conduit showed 100% secondary patency, 78% primary assisted patency, and 0% infections, marking a notable enhancement over the current standard of care.

“The outstanding 12-month data from our FIH study highlights aXess’ potential to transform the field of vascular access as a whole by stopping the cycle of interventions and infections,” said Eliane Schutte, CEO of Xeltis. “These latest results, alongside the excellent progress in enrollment for our pivotal trial, brings us closer to bringing our breakthrough solution to hemodialysis patients worldwide.”

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