Dive Brief:
- Edwards Lifesciences received FDA approval on Thursday for its Pascal Precision system. The device uses minimally invasive surgery to repair the mitral valve in patients with degenerative mitral regurgitation, a condition where the valve between heart chambers doesn’t close completely, allowing blood to leak back through.
- In the U.S., it is the company’s first approved treatment for the condition. In August, Edwards received a CE Mark, allowing it to offer the device in Europe.
- The sooner-than-expected approval could allow Edwards to kick off a soft launch earlier, RBC Capital Markets Analyst Shagun Singh wrote in a Thursday note.
Dive Insight:
Most of Edwards’ business to date for its transcatheter mitral and tricuspid valve repair segment has been in Europe, where it has been marketing an earlier version of its Pascal system since 2019.
In its most recent earnings report, the company forecast $110 million to $140 million in revenue for the segment for 2022. The approval is already factored into its financial expectations, the company said in a Thursday news release.
The FDA’s decision positions Edwards to bring a competitor in the U.S. to Abbott Laboratories’ MitraClip device, which currently leads the market. Although there is pent-up demand for the treatment, Edwards seems to be planning a more gradual ramp up of sales, RBC’s Singh wrote.
“Based on our conversations, we believe [Edwards] is planning a very strategic, methodical launch, which they indicated may not be as aggressive as some might want, i.e. they will not be looking to maximize sales from day 1,” Singh wrote. “Instead, the company will partner with [key opinion leaders] and leading hospitals in order to drive positive outcomes.”
The company plans to present data on Saturday of its CLASP IID pivotal trial at the Transcatheter Cardiovascular Therapeutics symposium. The randomized controlled trial directly compared two transcatheter edge-to-edge repair devices, Edwards stated.
Singh wrote that the news implies that the study met its primary endpoint of non-inferiority, “but our conversations continue to suggest that the trial was not powered for superiority and should not be expected.”
