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Children’s Hospital Colorado today announced that it has joined the Xplore2 / Pivotal trial and is actively recruiting patients for the first-ever pivotal trial of a synthetic restorative pulmonary valve. To date, pediatric patients requiring right ventricular outflow tract reconstruction (RVOT) have been successfully implanted in the FDA-approved global study. RVOT reconstruction is a necessary procedure to correct certain congenital heart defects.
After implantation, restorative synthetic pulmonary heart valves – developed by medical technology company Xeltis – evolve into fully functioning natural heart valves through colonization by the patient’s own tissues. The porous microstructure of the implants allows the patient’s own tissue to populate the device and naturally form a new heart valve that supports functionality over time. During this time, the original synthetic structure, made of electrospun polymers, resorbs into the body.
“Regeneration of living heart valves in patients requiring RVOT reconstruction can dramatically alter their quality of life,” said David Morales, MD, director, Congenital Heart Surgery, Cincinnati Children’s Hospital and Professor, Department of Pediatrics at the University. of Cincinnati, who is the trial’s global principal investigator. “A device that lasts longer and potentially grows with the patient would reduce repeated procedures and the associated physical and psychological burden.”
Xplore2 / Pivotal is a prospective, non-randomized clinical study to evaluate the safety and efficacy of the restorative pulmonary valve in up to 50 patients undergoing RVOT reconstruction. The US FDA-approved investigational device exemption trial will be conducted at up to 15 centers in the US, Europe and Asia. The implanted patients will be followed for five years.
Data from 18 patients implanted with the Xeltis Restorative Pulmonary Valve in other ongoing clinical trials are promising, and the safety profile and positive performance observed over more than 60 patient-years of follow-up provide a strong indication of a potential best-in-class device to reduce reoperations and improve patients’ lives. There has been no ideal solution for these patients. It’s great that Children’s Hospital Colorado has been invited to participate in a clinical trial that may lead to an ideal valve solution for children in need of pulmonary valve replacement. “
Max Mitchell, MD, cardiothoracic surgeon and co-director of the extracorporeal membrane oxygenation program at Children’s Hospital Colorado
Two-year results from the ongoing Xplore-1 trial in 12 patients in Europe and Asia and one-year data from the US FDA-approved Xplore-2 early feasibility study (EFS) in six patients were recently published in the peer-reviewed journal Frontiers in Cardiovascular Medicine. Further results obtained in patients up to four years after surgery confirm consistently low rates of repeat operations and offer promising signs of the technology’s greater potential.
“The Xeltis Pulmonary Heart Valve is the most advanced heart valve with regenerative properties based solely on a biocompatible synthetic structure and the first synthetic restorative valve to enter a pivotal trial,” said Eliane Schutte, CEO of Xeltis. “We are extremely proud of the progress of our clinical program, which also includes two applications of small diameter blood vessels. All of our regeneration devices promise to deliver solutions that overcome the limitations of existing technologies – or the lack thereof altogether. “
In addition to its restorative pulmonary valve, Xeltis has developed the very first restorative synthetic coronary artery bypass grafting (CAP) to show long-term positive results in lengthy preclinical trials and the first-ever restorative synthetic vascular bypass surgery for patients requiring dialysis. .
Source:
Colorado Children’s Hospital
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