Five months after initiation, Xeltis has successfully completed enrollment for the Xplore-I clinical trial. Twelve patients, aged 2-12 years old, have been implanted with the world’s first bioabsorbable pulmonary heart valve. Surgeries have taken place at three sites across Europe and Asia: Gottsegen György Hungarian Institute of Cardiology’s Pediatric Cardiac Centre in Budapest, University Children’s Hospital in Krakow, and the Institut Jantung Negara in Kuala Lumpur.
“We are monitoring all patients very closely and early next year we will be able to give detailed information on the first of the 6-month follow-up checks,” said Xplore-I leading investigator Prof. Thierry Carrel, Head of the Department of Cardiovascular Surgery at University Hospital Bern. “What we have observed confirms our confidence in the potential of ETR as a new, alternative therapeutic approach in heart valve replacement,” he added.
The primary objective of Xplore-I is to assess the survival rate of patients undergoing Right Ventricular Outflow Tract (RVOT) reconstruction six months after surgery. RVOT reconstruction is an open-heart surgical procedure generally involving the replacement of the pulmonary heart valve.
“The Xplore-I trial is the first ever clinical use of a bioabsorbable heart valve. Its results could impact the standard of care for patients requiring a replacement of pulmonary valve. However, what is truly exciting is the potential to impact the future approach to cardiovascular treatment in the broadest sense as we expand our technology platform in several other meaningful applications,” commented Xeltis CEO, Laurent Grandidier. “This is a remarkable close to an outstanding year.”