PECA Labs has announced the successful first-in-human implant of the MASA valve, a polymeric valved conduit for pulmonary valve reconstruction in paediatric patients.
The novel polymeric valve previously received humanitarian use device (HUD) investigational device exemption (IDE) from the US Food and Drug Administration (FDA). The company has begun enrolment for the study at four clinical sites in the USA as part of its MASA Valve Early Feasibility Clinical Study (MVEFS).
Children’s Hospital of Philadelphia (CHOP, Philadelphia, USA) became the first site in the world to implant a MASA valve in a paediatric patient. This marks a significant milestone in PECA Labs’ mission to bring the first polymeric pulmonary valve to market and improve outcomes for patients.
The MASA valve was implanted in a 21-month-old child who had previously undergone an operation at approximately one year of age with a homograft (human tissue valve). The homograft had become severely stenotic and required immediate replacement, which was successfully achieved with a 14mm MASA Valve.
The patient showed encouraging early results from the MASA valve implantation, with promising valve functionality on early assessment, the company said.
“The MASA Valve does not use biologic or foreign tissue, which is expected to reduce the chance of calcification, immunity-based rejection, and valve shrinkage. The valve design also aims to reduce the amount of anti-thrombogenic drugs administered to the patient over the course of their lifetime. These factors should help greatly improve patient outcomes and could lead to fewer valve replacements over a child’s lifetime,” said David Morales, executive co-director of the Heart Institute at Cincinnati Children’s Hospital (Cincinnati, USA) and principal investigator in the MASA Valve trial. “If the study is successful, the MASA valve could offer a significant improvement in the treatment of cardiovascular congenital heart defects in children and save the patients and the health system significant amounts of money spent on cardiac care.”
“In designing the MASA Valve, we aimed to use our polymer platform to combine the best characteristics of homograft tissue, which reduces the antithrombotic therapy required, and mechanical valves, which offer improved durability, supply availability, and resistance to both calcification and shrinkage. We then improved upon them with a novel bileaflet design,” said Doug Bernstein, CEO, PECA Labs. “We are optimistic that the current study will validate our belief that the MASA Valve represents a new gold standard for congenital heart patients.”
The non-randomised MVEFS is slated to initially enrol 10 to 15 patients at up to five sites. Patients will be independently assessed via echocardiographic analysis of regurgitation and valve function, immediately post-operation, at 30 days, at six months, and at one year, followed by annual assessment until year five.
Data on reintervention and reoperation are due to be presented with the final data and compared with published results from a pivotal trial of a competitive device.