A Pittsburgh-based biotech company is celebrating the first successful human implant of its polymeric valved conduit device, a type of artificial valve for the heart to help blood flow in the right direction.
PECA Labs announced that the Children’s Hospital of Philadelphia served as the site where its MASA Valve was first placed in a pediatric patient.
"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," Doug Bernstein, CEO of PECA Labs, said in a statement. "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 biotech company received Humanitarian Use Device (HUD) and Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration and is now starting enrollment for a study at four locations across the country.
"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," Dr. David Morales, executive co-director of the Heart Institute at Cincinnati Children’s Hospital, and principal investigator in the MASA Valve trial, said in a prepared statement.
