FDA Nod Allows Edwards to Treat Pulmonary Regurgitation Patients

Edwards Lifesciences is closing out 2021 by nabbing a new approval from FDA. The Irvine, CA-based company said it won the nod for the use of the Edwards Sapien 3 transcatheter valve with the Alterra adaptive prestent for patients with severe pulmonary regurgitation.

The number of procedures for this treatment is smaller, the transcatheter aortic valve replacement  (TAVR) pioneer, noted. The company pointed out that pulmonic heart valve replacements represent a small fraction of the heart valve replacements done each year and it is generally required to replace valves in adolescent and adult patients suffering from Tetralogy of Fallot or other congenital heart valve defects.

"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,”said Larry Wood, corporate vice president, transcatheter aortic valve placement,  in a release  The Sapien 3 with Alterra provides a new treatment option that can reduce the number of invasive procedures these patients face in their lifetimes."

News of the approval comes at a time when hospital staffing shortages are wreaking havoc on medtech. Edwards is weathering the storm and has some potential growth drivers, Marie Thibault, an analyst with BTIG and former MD+DI Managing Editor, wrote.

“Edwards expects 12-15% y/y underlying TAVR sales growth for 2022 ($3.7 billion to $4.0 billion) and a $10 billion global TAVR market opportunity by 2028, with growth expected later during that timeframe from the asymptomatic severe aortic stenosis (AS) patient population,” Thibault wrote. “Work being started now in moderate AS patient population is expected to be a driver beyond 2028. The transcatheter mitral and tricuspid therapies market opportunity is expected to expand from $1 billion today to $5 billion by 2028, with Edward’s sales expected to roughly double to $140 million to $170 million in 2022.