Xeltis can now commence the clinical study of bioabsorbable heart valve

One-year follow-up results from a pediatric feasibility study of Xeltis bioabsorbable cardiovascular pulmonary graft was presented as late-breaker at the 96th American Association for Thoracic Surgery annual meeting. All five children, aged 4 to 12 years at study enrollment, had only one functioning heart ventricle as a result of congenital heart defects and showed significant improvement in their general conditions one year after surgery. The 12-month data also showed anatomical and functional stability of the graft and no device-related adverse events.

“All patients enrolled are approaching their two-year follow-up, and the results to date are remarkable,” said leading investigator and world-renowned cardiac surgeon, Professor Leo Bockeria, who performed all five cases at the Bakoulev Centers for Cardiovascular Surgery in Moscow. “If further proven,” he added, “this new technology may open up a new therapeutic approach in cardiovascular treatment.”

The success of this feasibility trial has paved the way for Xeltis to develop a bioabsorbable pulmonary heart valve, which will enter clinical trials in Europe this year. Xeltis is developing the first-ever bioabsorbable cardiovascular valves and vessels designed to harness the body’s innate healing process and enable Endogenous Tissue Restoration (ETR), the natural restoration of complex anatomical parts within the body. The U.S. FDA has recently granted “Humanitarian Use Device” (HUD) designation for the Xeltis bioabsorbable pulmonary heart valve for the correction or reconstruction of right ventricular outflow tract (RVOT).

“Our technology is designed to enable regenerative medicine via a medical device,” stated Laurent Grandidier, Xeltis CEO. “This is potentially a revolutionary approach in cardiovascular treatment and for the future of medicine.”

Endogenous Tissue Restoration
The feasibility trial was encouraged by excellent results from in-vivo studies showing ongoing replacement of the bioabsorbable graft by new, well-vascularized and functioning tissue, as a result of ETR one year after surgery.

ETR is enabled by the unique porous structure of Xeltis bioabsorbable implants, which is based on Nobel Prize-awarded science. The implants are designed to harness the body’s natural healing process, to pervade them with new healthy tissue, and form complex body parts before the implants get absorbed.

Xeltis bioabsorbable technology has potential to reduce the risk of complications and of repeated interventions associated with currently available non-bioabsorbable synthetic or animal-derived heart valves. The technology may therefore help reduce the disease burden for patients and the overall costs for healthcare systems.

About Xeltis
Xeltis is a European-based medical device company spearheading a revolutionary approach in cardiovascular and regenerative medicine called Endogenous Tissue Restoration (ETR). Xeltis is developing the first-ever bioabsorbable cardiovascular valves and vessels designed to harness the body’s innate healing process and enable natural restoration of complex anatomical parts within the body.

Xeltis’ technology has potential for broad application across a number of cardiovascular conditions and patient populations, serving as a platform to address hundreds of thousands of patients that require cardiac valve replacements and vascular interventions every year.

(Press release)