Clinical-stage medical device firm Xeltis has commenced the pivotal trial of its synthetic restorative pulmonary heart valve.
To date, the company has completed the right ventricular outflow tract (RVOT) reconstruction in paediatric patients, as part of the global Xplore2/Pivotal study.
RVOT reconstruction is a procedure that is required to correct certain congenital heart defects.
After implantation, Xeltis’ synthetic restorative pulmonary heart valves will be transformed into fully functioning and natural heart valves via colonisation by the patient’s own tissue.
The porous micro-structure of the implant allows the patient’s own tissue to populate it and naturally create a new heart valve that will become functional over time.
The Xplore2/Pivotal is a prospective, non-randomised and open label clinical study designed to evaluate the safety and efficacy of the restorative pulmonary heart valve in patients requiring RVOT reconstsruction.
Xeltis will enroll up to 50 patients aged 2-22 years in the FDA-approved investigational device exemption trial at up to 15 centres in the US, Europe and Asia.
The company will follow the implanted patients for five years.
Xeltis CEO Eliane Schutte said: “The Xeltis pulmonary heart valve is the most advanced heart valve with regenerative properties based only on a biocompatible synthetic structure and the first ever synthetic restorative valve to enter a pivotal trial.
“We are extremely proud of our clinical program progression, which also includes two small diameter blood vessel applications. All our regenerative devices promise to offer solutions that overcome the limitations of existing technologies – or the complete lack of them.”
The two-year results from the Xplore-1 trial carried out in 12 patients in Europe and Asia, as well as one-year data from the FDA approved early feasibility study (EFS) Xplore-2 in six patients have been revealed by the company.
According to the company, further outcomes from patients up to four years post-surgery confirm consistently low repeat re-intervention rates.
Apart from restorative pulmonary valve, Xeltis has also developed the restorative synthetic coronary artery bypass graft (CABG).
The company formed through the merger of two Dutch/Swiss university spin-offs. Currently, it has operations in the Netherlands and in the US.
