Xeltis Receives FDA Breakthrough Device Designation for aXess Vascular Access Conduit, Begins US Pivotal Trial

November 19, 2024—Xeltis recently announced that the FDA has granted Breakthrough Device designation for the company’s aXess vascular access conduit and that the first patient was enrolled in the aXess staged pivotal trial in the United States.

The aXess device is intended to enable the creation of a new, permanent, living vessel for hemodialysis vascular access, stated the company.

Xeltis, which is based in Eindhoven, the Netherlands, noted that the patient was treated by vascular surgeon Karl Illig, MD, at the Flow Vascular Institute in Houston, Texas.

In June 2024, the company announced that the FDA approved an investigational device exemption (IDE) to begin the pivotal study. The National Principal Investigator for the aXess United States pivotal trial is John Lucas III, MD, with Lucas Surgical Group, PA, in Greenwood, Mississippi.

“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,” commented Dr. Illig in the company’s press release. “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.” Dr. Illig is the Site Principal Investigator for the trial.

Dr. Lucas added, “The United States 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.”

Clinical data for aXess will be presented at the 51st annual VEITHsymposium, held November 19-23, 2024, in New York, New York. On November 23, Dr. Lucas will present an update on the United States IDE pivotal study. On November 21, Professor Frans Moll, MD, will present the full 2-year clinical results for aXess, advised the company.