Xeltis Initiates Pivotal Trial for aXess Graft in Hemodialysis Patients
核心洞察
Xeltis (搜索) has commenced a pivotal European clinical trial to assess the safety and efficacy of its aXess (搜索) graft in patients with end-stage renal disease (搜索) requiring hemodialysis (搜索).
The prospective, single-arm study aims to enroll 110 patients across up to 25 European centers, monitoring them over five years post-implantation.
aXess (搜索), designed for immediate use and to transform into a living blood vessel, has shown promising preliminary results in a first-in-human trial.
Xeltis (搜索) has announced the start of its AXESS (搜索) European pivotal trial, a significant step towards providing a novel vascular access solution for patients with end-stage renal disease (搜索) (ESRD) undergoing hemodialysis (搜索). The first two patients have been successfully implanted with the aXess graft at AZ Sint-Jan Brugge-Oostende AV in Bruges, Belgium, by vascular surgeon Dr. Jan De Letter, and subsequently discharged.
AXESS Pivotal Trial Details
The AXESS (搜索) trial is a prospective, single-arm study designed to evaluate the safety and performance of the aXess graft in ESRD patients needing hemodialysis (搜索). The trial plans to enroll 110 patients across up to 25 centers in Europe, with a follow-up period of five years. This pivotal trial builds upon the foundation laid by the AXESS first-in-human (FIH) trial, which completed enrollment in September 2022 with 20 patients. Full cohort data from the FIH trial are expected in 2023.
aXess Graft: A Novel Approach
The aXess (搜索) graft is designed to function immediately, similar to existing synthetic ePTFE grafts, while also promoting the formation of a living blood vessel. This transformation aims to facilitate prompt recovery after each dialysis session, potentially offering a safer and more durable vascular access option. According to Dr. De Letter, a device with these characteristics could significantly improve the quality of life for hemodialysis (搜索) patients.
Addressing Unmet Needs in Hemodialysis
Dr. An De Vriese, Head of Nephrology and Infectious Diseases at AZ Sint-Jan Brugge-Oostende AV, and one of the Coordinating Investigators of the AXESS (搜索) EU pivotal trial, highlighted the challenges faced by hemodialysis (搜索) patients. These include frequent hospital visits, repeated punctures, bleeding, extended waiting times, healing complications, and the risk of infections, all compounded by impaired renal function. The aXess trial aims to address these unmet needs by providing a vascular access solution that reduces these complications and improves patient outcomes.