FDA Clears SAPIEN 3 With Alterra Prestent for Pulmonary Valve Replacement

The US Food and Drug Administration (FDA) has cleared Edwards Lifesciences’ SAPIEN 3 transcatheter valve with the Alterra adaptive prestent for pulmonic heart valve replacement, the manufacturer announced today.

In a press release, Edwards said the SAPIEN 3 Transcatheter Pulmonary Valve (TPV) system “compensates for variations in size and morphology of the right ventricular outflow tract (RVOT) to provide a stable landing zone for the SAPIEN 3 valve.”

According to Evan Zahn, MD (Cedars-Sinai Medical Center, Los Angeles, CA), principal investigator for the ALTERRA clinical trial, which helped support the approval, this is welcome news for patients with congenital pulmonary disease, many of whom otherwise face numerous surgical procedures.

"The outstanding outcomes achieved by SAPIEN 3 with Alterra will expand the range of patients who require pulmonary valve replacement that we can now treat with minimally invasive therapy,” Zahn said in a press release. “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.”

The FDA approved the device for the management of children and adults with severe pulmonary regurgitation on echocardiography, who have a native or surgically repaired RVOT and are clinically indicated for surgical pulmonary valve replacement. Earlier this year, the FDA approved another device, the Harmony transcatheter pulmonary valve (TPV) system (Medtronic) as the first nonsurgical heart valve to treat pulmonary valve regurgitation in pediatric and adult patients with a native or surgically repaired RVOT.