Xeltis, a developer of transformative implants, announced that the FDA has granted Breakthrough Device Designation to its aXess vascular access conduit. Simultaneously, the first patient has been enrolled and treated in the US pivotal trial of aXess at the Flow Vascular Institute in Houston, Texas.
The Breakthrough Device Designation acknowledges aXess' potential to provide a more effective treatment option for patients needing hemodialysis vascular access, addressing the limitations of current therapies. The device aims to create a new, permanent, living vessel for hemodialysis, potentially reducing frequent reinterventions and complications such as infections.
Eliane Schutte, CEO of Xeltis, stated, "We are in a transformative period for Xeltis, and 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."
Dr. Karl Illig, Vascular Surgeon and site Principal Investigator for the aXess US pivotal trial, added, "aXess has the potential to be a truly groundbreaking advance in the vascular access field, as it enables the creation of a new, permanent, living vessel. We hope that its ability to avoid the frequent reinterventions and infections associated with current treatment options will make a major difference to patients and their care."
The Breakthrough Device Designation grants Xeltis accelerated interactions with FDA review teams, prioritized review, and special reimbursement consideration, facilitating enhanced market access and expediting commercialization. This designation underscores the urgent need for innovative solutions in hemodialysis vascular access, where current treatments often lead to complications and repeated interventions.
Dr. John Lucas III, Surgeon at Lucas Surgical Group, P.A. and national Principal Investigator for aXess US pivotal trial, noted, "The US trial for aXess is an important step in assessing and validating the ability of this unique conduit to transform the field of vascular access. The 12-month data from the first-in-human study in Europe is extremely promising and I look forward to working on this next clinical stage in Xeltis' journey."
Further clinical data on aXess will be presented at the VEITH Symposium, with Dr. Lucas providing an update on the US IDE Pivotal Study and Prof. Frans Moll presenting the full 2-year clinical results. These presentations will offer a deeper insight into the device's performance and its potential to improve outcomes for hemodialysis patients.
