FDA permits Xeltis to begin trials in the USA

Xeltis has been granted permission by the US Food and Drug Association to begin its Xplore-II clinical trial for its pulmonary valve in the United States. The startup aims to reduce the risk of complications and of re-interventions in this pediatric population.

Xeltis developed the world’s first bioabsorbable pulmonary heart valve which allows for cardiovascular restoration among pediatric patients. Yesterday, the startup announced that the United States Food and Drug Association (FDA) approved the Investigational Device Exemption (IDE) for its Early Feasibility Study (EFS) to implant the Bioabsorbable Pulmonary Valve in patients. Early feasibility studies allow for early clinical evaluation of devices, to provide proof of performance and initial clinical safety data. Thanks to the IDE approval, Xeltis can now initiate its Xplore-II clinical in the USA.

The Xplore-II study will be conducted in up to five centers in 10 pediatric patients, with William Gaynor, Managing Director from the Children’s Hospital of Philadelphia serving as the Principal Investigator. The U.S. trial follows the successful completion of enrolment 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 William Gaynor. “There is a clear need to reduce the risk of complications and of re-interventions in this pediatric population.”

 “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.