The US FDA has approved the Investigational Device Exemption (IDE) for Xeltis’ Early Feasibility Study (EFS) to implant its Bioabsorbable Pulmonary Valve in patients. IDE approval allows Xeltis to initiate the Xplore-II clinical trial for its pulmonary valve in the USA.
The Xplore-II study will be conducted in up to five centers in 10 pediatric patients, with William Gaynor, M.D., from the Children’s Hospital of Philadelphia serving as the Principal Investigator. The U.S. trial follows the successful completion of enrollment of 12 patients in the Xplore-I feasibility trial for Xeltis’ pulmonary valve in Europe and Asia in December 2016.
“The Xplore-II trial will provide further understanding of the properties of Xeltis’ pulmonary heart valve in patients,” commented Dr. William Gaynor. “There is a clear need to reduce the risk of complications and of re-interventions in this pediatric population.”
Early feasibility studies allow for early clinical evaluation of devices, to provide proof of performance and initial clinical safety data.
“This is Xeltis’ first step into the USA and a very important one for the company globally”, said Laurent Grandidier, CEO at Xeltis. “Undergoing feasibility trials in the USA, Europe and Asia in parallel demonstrates the pace of our progression to bring our RestoreX technology to market” – he added.