Xeltis’ polymers have shown superior pro-healing response and no calcification compared to conventional biological heart valve devices in preclinical trial results just published in the Journal of Biomedical Materials Research – Part A. The study compared the tissue response of a biologic scaffold composed of bovine pericardium, the standard of care for heart valve replacement, with that of a Xeltis electrospun supramolecular polymer scaffold and other biological and synthetic devices.
The trial results showed that more pro-healing macrophages (M2) and fewer pro-inflammatory (M1) macrophages formed with the Xeltis device compared to conventional biological devices. The balance of macrophage types is regarded as an important determinant of biocompatibility and remodeling outcomes. In addition, the Xeltis implant was markedly less susceptible to calcification compared to biological implants for the 180-day duration of the study.
“The current results further substantiate the use of supramolecular polymers in heart valve and other cardiovascular implants for their biocompatibility and potentially reduced inflammatory response,” stated Professor Stephen F. Badylak, Department of Bioengineering, University of Pittsburgh (PA, USA), senior author of the JBMR-A paper.
“The success or failure of a biomaterial in the clinical setting is ultimately dependent upon its biocompatibility. The study results provide optimism that the properties demonstrated by the Xeltis implants in this preclinical study predict favorable clinical outcomes,” concluded Professor Frederick J Schoen, Department of Pathology, Brigham and Women’s Hospital and Harvard Medical School, Boston (MA, USA), a global authority in biomaterials, who also co-authored the study.