Edwards gets CE mark for Pascal Precision system, allowing device to be marketed in Europe – MedTech Dive

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Dive Brief:

  • Edwards Lifesciences received a CE mark for its Pascal Precision system, its newest treatment for patients with mitral and tricuspid regurgitation, the company said on Wednesday.
  • Mitral and tricuspid regurgitation are conditions where the valves between heart chambers don’t close completely, allowing blood to leak back through. The Pascal Precision system involves minimally invasive surgery to repair the valve, with paddles to help bring the mitral leaflets back together, and a central spacer.
  • With the regulatory approval, Edwards will be able to start marketing the surgical device in Europe. The company also is on track to get approval from the Food and Drug Administration before the end of the year, CEO Mike Mussallem said on a July 29 earnings call. 

Dive Insight:

Edwards got a CE Mark for its first Pascal system in 2019. The Pascal Precision system is designed to enable precise navigation and implant delivery, the company said in a statement. It works with both the company’s Pascal and Pascal Ace implants. 

“Delivering the Pascal Precision system to clinicians in Europe marks another significant step in our partnership with physicians who treat the large population of patients with mitral and tricuspid valve disease,” Bernard Zovighian, Edwards’ vice president of transcatheter mitral and tricuspid therapies, said in a news release.

Edwards has targeted transcatheter mitral and tricuspid therapies (TMTT) as a growth driver for the business. The company reported TMTT sales of $28 million in the second quarter, a 26% year-over-year increase. 

So far, most of the sales are generated in the European Union. For the full year, Edwards forecasts revenue of $110 million to $140 million in the segment. 

The company also has other treatments in the works. Edwards is pursuing a late 2022 approval in Europe for its Evoque tricuspid valve replacement system, although the process is “more uncertain” under the new Medical Device Regulation process, Zovighian said in the July 29 earnings call.

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