The FDA approved a new version of Edwards Lifesciences’ Sapien 3 transcatheter heart valve—coupling it with a self-expanding, stent-like device that helps reshape a malfunctioning pulmonary valve. Known as the Alterra adaptive prestent, the extra hardware surrounds the valve and helps compensate for differences in the size and shape of a heart’s right ventricular outflow tract—which includes the three-leaflet pulmonary valve and directs blood into the lungs to gather oxygen on its trip through the body.
This provides the minimally invasive implant with a more stable landing zone among patients who have severe valve leaks and backflow of blood into the heart, including adults and children with congenital heart disease and especially in those with outflow tracts that may be too large in diameter for previous replacement valves. ‘This will result in significant improvements in quality of life and a reduction in the number of surgeries and procedures that a congenital heart patient requires over the course of their lifetime,” said Evan Zahn, principal investigator of a clinical trial for the Alterra-equipped implant and director of Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center’s Smidt Heart Institute.
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Though the number of pulmonary heart valve replacements represents a small fraction compared to the volume of procedures to restore the heart’s aortic and mitral valves, replacing the valves is generally required in adolescents and adults suffering from rare cardiac defects, which can cause oxygen-poor blood to flow out of the heart and into the rest of the body.
“Many of these patients endure repeated open-heart surgeries to address heart conditions present since birth, which takes a huge toll on their ability to lead normal lives,’ Larry Wood, Edwards’ vice president of transcatheter aortic valve replacement, said in the statement.
Severe pulmonary valve regurgitation can follow previous surgeries on the right ventricular outflow tract needed to address congenital defects such as a condition known as tetralogy of fallot.
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Typically addressed in younger patients—and with an average lifespan of about a decade for a valve implant—some may have to undergo five or six replacement surgeries over their lifetime, according to Alejandro Torres, director of pediatric cardiac catheterization laboratories at NewYork-Presbyterian Morgan Stanley Children’s Hospital, a participating site in the Alterra trial.
‘This procedure enables us to interventionally place a valve and then another valve within the valve, allowing these patients to gain possibly another 20 to 30 years before they might need to undergo open heart surgery again,’ added Torres.
https://www.fiercebiotech.com/medtech/edwards-grabs-fda-approval-for-sapien-3-pulmonary-replacement-valve-pre-stent
