Xeltis' aXess Receives FDA IDE Approval for US Pivotal Trial in Hemodialysis Vascular Access
Key Insights
Xeltis (search) has received FDA approval for an Investigational Device Exemption (IDE) to initiate a US pivotal trial for its aXess (search) vascular access conduit.
aXess (search) is designed to create a new, living vessel for hemodialysis, combining the benefits of arteriovenous fistulas and grafts, potentially reducing complications.
The US trial follows positive 12-month data from a European first-in-human study and will run parallel to an ongoing EU pivotal trial.
Xeltis (search), a developer of regenerative implants, has received FDA IDE approval to begin a pivotal US trial for aXess (search), its restorative arteriovenous dialysis conduit. This approval allows Xeltis to enroll patients in a study evaluating the device's ability to create a new, permanent, living vessel for hemodialysis vascular access.
aXess: A Restorative Vascular Access Solution
aXess (search) is designed to combine the safety and patency of an arteriovenous fistula (AVF) with the speed to treatment of an arteriovenous graft (AVG). The goal is to provide an improved experience for dialysis patients by reducing the need for frequent reinterventions and minimizing complications such as infections, which are common in patients with renal disease (search).
The device leverages Xeltis (search)' endogenous tissue restoration (ETR) platform, which utilizes a biodegradable polymer implant. Over time, the implant is intended to be gradually replaced by the patient's own healthy tissue, resulting in a new, living, and long-lasting vessel.
Clinical Trial Details and Prior Data
The US-based pivotal trial follows promising 12-month data from a first-in-human trial conducted in Europe. In this earlier study, aXess (search) demonstrated a significant improvement in performance compared to existing hemodialysis vascular access solutions. Xeltis (search) is also currently conducting an EU pivotal trial, which is recruiting up to 110 patients across nine European countries.
According to Xeltis (search), in the first-in-human European trial, all 20 patients enrolled demonstrated 100% secondary patency and 78% primary assisted patency at 12 months. The company defines graft patency as any flow through both the graft and the native vessel.
Leadership Perspective
Eliane Schutte, CEO of Xeltis (search), stated, "We are very proud of the potential for aXess (search) to transform the field of vascular access by stopping the cycle of interventions and infections and bringing our unique restorative solution to hemodialysis patients worldwide."
Paulo Neves, Chief Medical Officer of Xeltis (search), added, "Our focus is on improving the outcomes for patients on dialysis. aXess (search) offers this potential through its avoidance of the reinterventions and complications associated with other vascular access solutions. This pivotal study is important in assessing and demonstrating this and marks a significant milestone in our clinical strategy in the US."
Market Context
Approximately 3.5 million patients with end-stage renal disease (search) undergo long-term dialysis each year. A common method for vascular access involves creating a fistula, but these can be prone to infections from bacteria like Staphylococcus aureus and Staphylococcus epidermidis. Xeltis (search) aims to address these challenges with aXess (search).
GlobalData analysis projects the global vascular access device market for hemodialysis to reach $937 million by 2030, with the vascular access graft segment estimated at $633.6 million.