Pulmonary Heart Articles & Analysis: Older
5 news found
Xeltis currently has three restorative devices in clinical trial phase, including aXess – a restorative access graft for dialysis; XABG – which is a coronary artery bypass graft; and its pulmonary heart valve, which was the first ever synthetic valve to enter a pivotal trial (Xplore2/Pivotal) in July this year. ...
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery ...
” Eliane Schutte, Xeltis CEO, added: “EIB financial support can make the difference in the time our restorative heart valves and blood vessels reach patients that today have limited or no options at all for their conditions. ...
RVOT reconstruction is a procedure needed to correct certain congenital heart defects. Following implantation, Xeltis’ synthetic restorative pulmonary heart valves evolve into fully functioning, natural heart valves through colonization by the patient’s own tissue. ...
Xeltis bio-restorative pulmonary heart valves and their clinical outcomes will feature at the upcoming Pediatric Device Innovators Forum organized by the U.S. ...