Clinical data on Xeltis’ RestoreX technology have been published in The Journal of Thoracic and Cardiovascular Surgery, a leading peer-reviewed journal. The published data showed positive functionality in patients two years after implanting a Xeltis bioabsorbable vascular graft.
The feasibility study assessed initial safety and clinical performance of Xeltis’ novel bioabsorbable vascular graft in five pediatric patients. The successful first clinical experience with a cardiovascular device based on RestoreX technology was a clear proof-of-concept for the potential of the technology to improve cardiovascular procedures. Results from this study supported the initiation of the Xplore-I feasibility trial for Xeltis pulmonary valve in EU and Asia and the soon to launch feasibility trial Xplore-II in the USA.
“The data demonstrate exciting clinical potential with bioabsorbable technology in cardiovascular surgery,” stated Professor Thierry Carrel, Head of the Department of Cardiovascular Surgery at University Hospital Bern and one of the authors of the paper. “The excellent biocompatibility could provide clinical benefits, such as improved performance and reduced long-term complications associated with mechanical or current biological devices,” he added.
The two-year clinical data were first presented at the 30th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting in 2016. View the full press release here.