Xeltis Announces First Commercial Implant of aXess™ Vascular Access Device in Europe, Marking Global Launch

Recently, medical device innovation company Xeltis officially announced that its novel vascular access deviceaXessThe commercialization process has officially commenced in Europe. It is reported that Professor Dominik Liebetrau from the Department of Vascular Surgery at Artemed Klinikum Munich South in Germany led his team to successfully complete the first commercial patient implantation of this device worldwide.

Innovative “Living” Vascular Access Concept

aXess is a restorative vascular access graft specifically designed for hemodialysis treatment. Unlike traditional synthetic grafts, this device requires only a single surgical procedure for implantation. In the initial post-implantation phase, it serves as a robust “scaffold” that meets clinical cannulation needs; subsequently, the device gradually remodels into the patient’s own living blood vessel, thereby providing long-term, reliable vascular access.

Compelling 12-Month Clinical Data Support

This commercial launch is built upon the positive 12-month follow-up data from the pivotal European clinical trial of aXess. The data show:

• Excellent Patency Rate: Its secondary patency rate is comparable to that of mature autogenous arteriovenous fistulas.
• Low incidence of complications: Compared with historical baseline data for synthetic arteriovenous grafts, aXess demonstrates a significantly lower reintervention rate and exhibits exceptional resistance to infection.

Xeltis stated that this initial implantation marks the beginning of the comprehensive rollout of aXess in Europe, offering differentiated vascular access solutions to more physicians and patients, with the potential to reshape the current landscape of hemodialysis treatment.

Perspectives from Key Experts and Executives

• Professor Dominik Liebetrau (Department of Vascular Surgery, Artemed Hospital South Munich):

“aXess integrates seamlessly into our existing surgical workflows, allowing for smooth adoption by the team. It introduces a disruptive new concept in vascular access—implants designed to ultimately transform into the patient’s own living blood vessels. This provides a highly valuable clinical option for patients requiring long-term hemodialysis, with the potential to significantly improve treatment outcomes and quality of life.”

• Eliane Schutte (CEO of Xeltis):

“The first commercial implantation of aXess marks the official transition of this technology from the clinical development phase to routine clinical practice. This is a significant milestone for Xeltis and the starting point of our commercialization efforts in Europe. Building on this foundation, we will establish the groundwork for broader adoption across Europe and, eventually, in the U.S. market.”

• Elmar Horn (Vice President of Business, Xeltis):

“The first commercial implantation underscores the joint efforts of our team and collaborating physicians. Our next focus is to fully support the participating centers in implementing the clinical application of aXess, delivering a high-quality experience for both patients and healthcare providers, and steadily expanding patient benefits across Germany and throughout Europe.”

• Dr. Peter A. Schneider (Member of the Xeltis Medical Advisory Board):

“This marks the first time we have obtained a ‘non-autologous’ graft that, over time, can ultimately transform into the patient’s own blood vessels and function similarly to autologous vessels through vascular cell ingrowth and tissue regeneration. This innovative approach perfectly combines ‘early cannulability’ with the ‘long-term benefits of living vessels,’ holding promise for addressing the significant unmet need that has long persisted in the field of vascular access.”

Steady Progress in the Global Strategic Layout

As commercialization launches in Europe, Xeltis is simultaneously advancing the pivotal clinical trial of aXess in the U.S. market, with patient enrollment currently exceeding 50%. Building on the positive clinical data from Europe, this U.S. study will further support the company’s global commercial strategy.