Xeltis, a Dutch company, has achieved two significant milestones for its aXess vascular access conduit: FDA Breakthrough Device designation and the enrollment of the first patient in its pivotal trial.
FDA Breakthrough Device Designation
The FDA has granted Breakthrough Device designation to aXess, Xeltis' lead product. This designation is designed to accelerate the development, assessment, and review of medical devices that offer a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. With this designation, Xeltis will benefit from enhanced interaction with FDA experts and prioritized review of its regulatory submissions.
First Patient Enrolled in Pivotal Trial
Simultaneous with the FDA announcement, Xeltis revealed the enrollment and treatment of the first patient in its pivotal trial of aXess. The trial is a prospective, single-arm, multi-center study designed to evaluate the safety and performance of aXess in adult patients with end-stage renal disease (ESRD) who require dialysis. The study is being conducted under an investigational device exemption (IDE) granted in June.
Addressing the Need for Improved Vascular Access
Patients with ESRD undergoing regular dialysis require a reliable vascular access point. Arteriovenous fistulas (AVF) are typically the preferred choice, but grafts or catheters may be necessary depending on individual patient factors. Approximately 3.5 million patients worldwide are on long-term dialysis each year. While AVFs are generally reliable, they are susceptible to infections from bacteria such as Staphylococcus aureus and Staphylococcus epidermidis.
How aXess Works
aXess is a synthetic vascular access device engineered to transform into a living blood vessel over time. The device consists of a 6mm inner diameter tube made of a polymer matrix that facilitates colonization by the patient's own tissue cells. Xeltis aims to reduce infection and reintervention rates compared to traditional arteriovenous grafts, offering an improved vascular access option for patients unsuitable for fistulas.
Clinical Data
Xeltis has previously reported positive 12-month data from a first-in-human European trial (NCT04898153). The trial enrolled 20 patients and demonstrated 100% secondary patency and 78% primary assisted patency at 12 months. Graft patency was defined as flow through both the graft and the native vessel.
Executive Commentary
Xeltis’ CEO Eliane Schutte stated, “This designation from the FDA is great recognition of the potential importance of our highly novel technology. We are also extremely proud that the first patient in our US pivotal trial has now been treated, and this clinical achievement provides us with significant momentum as we advance towards commercialization.”
Competition in the Vascular Access Space
Other companies are also developing innovative solutions for vascular access. Concept Medical received an IDE for its MagicTouch AVF device, a sirolimus-coated balloon designed to treat stenotic lesions in hemodialysis patients. Merit Medical reported positive six-month data from a trial of its WRAPSODY endoprosthesis, a cell-impermeable stent graft intended to extend long-term vessel patency in dialysis patients requiring an AVF.
