Summary
Xeltis announced CE marking for aXess on April 21, 2026 and the first commercial implantation in Germany on July 7, 2026. This supports an early European rollout, not universal availability. The reviewed SSCP is manufacturer documentation, not an independently verified CE certificate. [21][19][18]
In the United States, aXess remains investigational. Its pivotal study, NCT06494631, lists enrolling by invitation in the latest July 2026 registry update. Xeltis reports FDA Breakthrough Device Designation; that designation and clinical-study permissions are not FDA marketing approval. [11][3]
Xabg and Xpad remain in clinical evaluation. The pulmonary-valve study NCT03022708 is active, not recruiting, with results posted in August 2026. Current registry status is used instead of older enrollment language on the study website. Planned completion dates and enrollment targets are not completed milestones. [2][4][5][1]
The aXess SSCP identifies a Class III EU device with bioresorbable polymer layers and a nitinol support structure. Tissue restoration is the intended mechanism, not proof of superior lifetime outcomes. Clinical comparisons with historical benchmarks are not randomized head-to-head evidence; the IFU and SSCP retain device risks, including thrombosis, stenosis and infection. [18][16]
Selected exact-name FDA 510(k), PMA and recall searches did not establish matching records. These searches are incomplete, and De Novo was not checked. [6]
