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The patient’s own tissue naturally turns the device into a living heart valve and may reduce the need for re-intervention
Celtis, A clinical-stage company with the most advanced polymer-based repair cardiovascular equipment, today announced that it has begun the first key trial of a synthetic repair pulmonary valve. So far, as part of the global FDA-approved Xplore2/Pivotal study, pediatric patients who need right ventricular outflow tract (RVOT) reconstruction have been successfully implanted. RVOT reconstruction is a procedure required to correct certain congenital heart defects.
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Xeltis synthetic repair pulmonary heart valve has evolved into a fully functional natural heart valve through the colonization of the patient’s own tissues. (Photo: Business Wire)
After implantation, Xeltis’s synthetic repair pulmonary heart valve evolved into a fully functional natural heart valve through the colonization of the patient’s own tissues. The porous microstructure of the implant allows the patient’s own tissue to fill it and naturally form a new heart valve, taking over the function over time. At the same time, the original synthetic structure made of electrospun polymer is absorbed into the body.
“Revitalizing heart valves in patients who need RVOT reconstruction may significantly change their quality of life,” said David Morales, MD, director of congenital heart surgery at Cincinnati Children’s Hospital, professor of pediatrics at the University of Cincinnati, and global lead researcher David Morales, MD. “A device that lasts longer and may grow with the patient will reduce repeated interventions and the physical and mental burden associated with it.”
Xplore2/Key It is a prospective, non-randomized clinical study designed to evaluate the safety and effectiveness of repairable pulmonary valves in up to 50 patients undergoing RVOT reconstruction. The FDA-approved research device exemption trials will be conducted in as many as 15 centers in the United States, Europe and Asia. The implanted patients will be followed up for five years.
“As part of other ongoing clinical trials, data from 18 patients implanted with Xeltis repair pulmonary valves are very promising,” said Professor Tomasz Mroczek, a cardiothoracic surgeon at the American Children’s Hospital in Poland.
The full story on Benzinga.com
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