Medtronic provided new data from two clinical trials evaluating the long-term safety and short-term performance of its pulmonary valve catheter replacement therapies for children with congenital heart disease.
Presented virtually as late-breaking studies at the Society for Cardiovascular Angiography and Interventions Scientific Session, 10-year data showed sustained function and stable hemodynamics with the company’s Melody valve compared to a group historical witness using a surgically implanted conduit. In addition, 97% of patients experienced mild, trace or no pulmonary regurgitation after a decade.
“Having long-term data is an important step, especially for this pediatric patient population that grows and changes so rapidly over a 10-year period,” said Thomas Jones, director of cardiac catheterization at Seattle Children’s, in a statement.
According to Medtronic, congenital heart disease is the most common type of birth defect in the United States, affecting approximately 40,000 infants each year. About 22% have structural defects in the part of the right ventricle that helps connect the heart to the lungs, and typically undergo open heart surgery to help increase blood flow.
Many patients can have a tube implanted early in life, but once that conduit is no longer functional, the Melody Transcatheter Valve is designed as a method to help delay further procedures. In the 10-year study, 61% of implanted patients did not require additional surgery or reoperation through a catheter.
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Meanwhile, a new study of Medtronic’s experimental Harmony valve, designed for patients who have received a transannular patch, with significantly deformed parts of their right ventricle, has met its criteria for safety and efficacy at six months.
The 50 treated patients experienced no procedure- or device-related mortality after one month, with acceptable hemodynamic function at six months maintained in 89% of participants. At the same time, 94% of patients had mild or no pulmonary regurgitation, while 97% had mild or no paravalvular leakage.
“These crucial data support the rationale for a potential new therapy designed specifically for the right ventricular outflow pathway,” said principal investigator John Cheatham, professor emeritus of pediatric cardiology at Nationwide Children’s Hospital. “If the data from future studies continues to be strong, we hope that Harmony has the potential to impact this critical and difficult-to-treat segment of patients, who have limited treatment choices with current transcatheter technologies. .