Edwards Lifesciences said expanded use of its Pascal transcatheter valve repair system drove strong sales in the first quarter as an increasing number of heart centers adopt the technology.
Meanwhile, the company’s Evoque tricuspid valve replacement device, newly approved in the U.S., is receiving positive feedback from physicians, Edwards CEO Bernard Zovighian said on a Thursday earnings call.
“The increasing physician demand for Evoque is a clear indication of unmet need and the potential for this therapy to treat a very large patient population,” Zovighian told analysts.
In February, Evoque became the first transcatheter procedure to receive Food and Drug Administration approval to treat patients with tricuspid regurgitation. The minimally invasive transcatheter approach avoids the need for open-heart surgery.
Abbott followed soon after, gaining FDA approval earlier this month for a competing transcatheter tricuspid treatment, Triclip, based on its Mitraclip technology for the mitral valve.
Zovighian said sales in Edwards’ transcatheter mitral and tricuspid therapies (TMTT) business grew by 72% year over year in the first quarter to $73 million.
“TMTT is becoming an increasingly significant contributor to Edwards’ growth, and we expect this will continue,” Zovighian said.
Based on strong adoption of the treatments, Edwards raised its outlook for full-year TMTT sales to a range of from $320 million to $340 million. The previous outlook was on the higher end of a range of from $280 million to $320 million.
TAVR lags expectations
Sales in the company’s transcatheter aortic valve replacement (TAVR) segment, its largest business, grew about 6%, a little shy of consensus expectations, several analysts said.
RBC Capital Markets analyst Shagun Singh attributed the softness to pricing pressures in Europe. But the company expects the business to improve in the second quarter as it prepares to launch its Sapien 3 Resilia technology in the European market, Singh said in a report to clients.
“We expect full-year 2024 performance to normalize,” Zovighian said on the call.
William Blair analyst Margaret Kaczor Andrew wrote that “U.S. TAVR growth coming in above the company’s global rate is a positive signal though for further acceleration in the patient funnel that has lagged a return since COVID.”
Critical care spinoff
Edwards executives said preparations for the spinoff of the company’s critical care business, announced in December, are on track.
“We are currently assessing capital structure options for the spinoff company, and we plan to share details with investors later this year,” CFO Scott Ullem said.
The critical care unit reported better-than-expected first-quarter sales of $251 million, up 13% from a year ago.
