Xeltis' aXess Receives FDA Breakthrough Device Designation and Enrolls First Patient in Pivotal Trial
核心洞察
Xeltis (搜索)' aXess (搜索), a synthetic vascular access device, has been granted Breakthrough Device designation by the FDA, expediting its path to market.
The pivotal trial, a prospective, single-arm, multi-center study, is evaluating the safety and performance of aXess (搜索) in adults with end-stage renal disease needing dialysis.
aXess (搜索) is designed to transform into a living blood vessel, potentially reducing infection and reintervention rates compared to existing arteriovenous grafts.
Xeltis (搜索) has achieved two significant milestones for its aXess (搜索) vascular access conduit: FDA Breakthrough Device designation and enrollment of the first patient in its pivotal trial. The FDA's decision is expected to accelerate the device's regulatory review process, while the trial aims to confirm the device's safety and efficacy in patients with end-stage renal disease requiring dialysis.
The aXess (搜索) device is a synthetic vascular access conduit engineered to transform into a living blood vessel over time. Constructed from a polymer matrix, the 6mm inner diameter tube is designed to be gradually colonized by the patient's own tissue cells. Xeltis (搜索) aims to address the challenges of infection and reintervention rates associated with current arteriovenous grafts, while also providing a viable vascular access option for patients unsuitable for fistulas.
The pivotal trial is a prospective, single-arm, multi-center study assessing the safety and performance of aXess (搜索) in adult patients with end-stage renal disease who require hemodialysis. This study is being conducted under an investigational device exemption (IDE) granted in June. Arteriovenous fistulas (AVF) are typically the preferred vascular access method for these patients; however, grafts or catheters are sometimes necessary. Approximately 3.5 million patients with end-stage renal disease undergo long-term dialysis annually. While AVFs are reliable, they are susceptible to infections from bacteria such as Staphylococcus aureus and Staphylococcus epidermidis.
Prior Clinical Data
Xeltis (搜索) previously reported positive 12-month data from a first-in-human European trial (NCT04898153) involving 20 patients. The results demonstrated 100% secondary patency and 78% primary assisted patency at 12 months. Graft patency was defined as blood flow through both the graft and the native vessel. These initial findings suggest aXess (搜索) has the potential to improve outcomes for dialysis patients.
Executive Perspective
Eliane Schutte, CEO of Xeltis (搜索), 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 Vascular Access
Other companies are also developing innovative solutions for vascular access. Concept Medical (搜索) received an IDE for its MagicTouch AVF (搜索) device, a sirolimus-coated balloon designed to treat stenotic lesions (搜索) in hemodialysis patients. Merit Medical (搜索) reported positive six-month data from its WRAPSODY trial, which is evaluating a cell-impermeable stent graft intended to extend long-term vessel patency in dialysis patients requiring an AVF.