Following implantation, Xeltis’ synthetic restorative pulmonary heart valves evolve into fully functioning, natural heart valves through colonization by the patient’s own tissue. The implants’ porous micro-structure enables the patient’s own tissue to populate it and naturally form a new heart valve that takes over functionality over time. Meanwhile, the original synthetic structure, made from electrospun polymers, resorbs into the body.
This week, pediatric patients requiring right ventricular outflow tract (RVOT) reconstruction have been successfully implanted as part of the global, FDA-approved Xplore2/Pivotal study. RVOT reconstruction is a procedure needed to correct certain congenital heart defects. The goal of a Pivotal study is to collect definitive evidence of the safety and effectiveness of a device before applying for market approval.
Xplore2/Pivotal is a prospective, non-randomized clinical study to assess safety and efficacy of the restorative pulmonary valve in up to 50 patients undergoing RVOT reconstruction. The U.S. FDA-approved Investigational Device Exemption trial will be conducted in up to 15 centers in the U.S., Europe and Asia. The implanted patients will be followed-up for five years.
“Data from 18 patients implanted with the Xeltis restorative pulmonary valve as part of other ongoing clinical trials are very promising,” said Professor Tomasz Mroczek, cardio-thoracic surgeon at the Polish-American Children's Hospital in Krakow, Poland. Professor Mroczek implanted the first patient of the Xplore2/Pivotal trial and had also previously implanted three pediatric patients as part of the ongoing Xplore-1 study for the Xeltis pulmonary valve. “The positive safety profile and performance seen in over 60 patient-years of follow-up provide strong indication of a potential best-in-class device to reduce re-operations and improve lives for patients.”
(Press release / SK)
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