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The FDA gave the greenlight to transcatheter pulmonic valve replacement with the Sapien 3 system plus an adaptive pre-stent landing zone, dubbed Alterra, for patients with congenital heart disease.

Edwards Lifesciences the approval Monday for management of both pediatric and adult patients with severe pulmonary regurgitation on echocardiography who are candidates for surgical replacement, whether the right ventricular outflow tract is native or previously surgically repaired.

Pulmonic valves are a small market, the company acknowledged -- often adolescents and adults with deterioration after tetralogy of Fallot or other congenital heart valve defect procedures.

"The FDA approval of the SAPIEN 3 with Alterra is great news for patients around the world, many of whom have endured numerous surgical procedures to treat their congenital heart disease," said Evan Zahn, MD, director of the Guerin Family Congenital Heart Program at the Smidt Heart Institute of Cedars-Sinai Medical Center in Los Angeles, in a statement from the company.

Citing "outstanding outcomes" along with "minimal complications, limited side effects and quick recovery times" seen in the for which he was principal investigator, Zahn suggested that the transcatheter device system would "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."

That single-arm trial included 85 patients treated open-label with the Sapien 3 valve and Alterra adaptive pre-stent, which is designed to compensate for variations in size and morphology of the existing right ventricular outflow tract and provide a stable, circular, semi-rigid seat for the new valve.

Zahn predicted a large shift in treatment for such patients toward the less invasive strategy. "The approval of this novel device for congenital heart disease patients with severe pulmonary regurgitation expands the population we can treat from about 15 percent to roughly 90 percent of patients," said Zahn in a press release from Cedars-Sinai.

Medtronic's Harmony transcatheter pulmonary valve was approved earlier in 2021 for treatment of severe pulmonary valve regurgitation with a native or surgically repaired right ventricular outflow tract, although not those with a prior valve or right ventricle-pulmonary artery (RV-PA) conduit.

Medtronic's Melody transcatheter pulmonary valve was approved in 2010 for use within an existing dysfunctional RV-PA conduit or bioprosthetic pulmonary valve.

"While the Harmony valve has been an important addition to our armamentarium for treating patients with pulmonary valve dysfunction, like all devices it has its limitations," Zahn told 乌鸦传媒. "Due to the unique design, size and configuration of the Alterra device, we will be able to further expand the number of patients as well as the types of patients who can be safely treated with transcatheter valve therapy."

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