A second feasibility trial for Xeltis’ bioabsorbable cardiovascular device technology has shown positive results in patients a year after surgery. According to a press release, Xeltis is the first medical device company to develop bioabsorbable cardiac valves and vessels designed to allow Endogenous Tissue Restoration (ETR).
The Xeltis products are made of bioabsorbable polymers structured as a porous matrix that is designed to work as valve or other cardiovascular component once implanted and to allow ETR, as the body’s natural healing process pervades it with new functioning tissue. As the natural cardiovascular part forms, the matrix is structured to be absorbed and to leave the patient with its own healthy tissue.
Laurent Grandidier, CEO at Xeltis, says, “We are confident that bioabsorbable cardiovascular devices will be able to replace most commonly used implantable devices, and that ETR will improve patient outcomes while reducing the economic burden for healthcare systems.“
In this study, young children born with only one functioning heart ventricle and requiring a Glenn procedure have been implanted a Xeltis cardiovascular patch as part of their operation. Results showed that all patients presented no patch-related post-operative complications and no functional impairment requiring intervention a year after surgery. The study was led by Leo Bockeria, Bakoulev Center for Cardiovascular Surgery, Moscow, Russia.
“A year after surgery, all clinical parameters are positive and provide hope that ETR may offer a more definitive solution to a number of cardiac conditions” Bockeria adds.