Edwards obtains CE marking for the Pascal Precision system, allowing the device to be marketed in Europe

ByLance T. Lee

Aug 19, 2022

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Diving Brief:

  • Edwards Lifesciences has received CE Marking for its Pascal Precision System, its newest treatment for patients with mitral and tricuspid regurgitation, the company announced. Wednesday.
  • Mitral and tricuspid regurgitation are conditions in which the valves between the chambers of the heart do not close completely, allowing blood to flow back. The Pascal Precision System involves minimally invasive surgery to repair the valve, with paddles to help bring the mitral leaflets together and a central spacer.
  • With regulatory approval, Edwards will be able to begin marketing the surgical device in Europe. The company is also on track to gain Food and Drug Administration approval before the end of the year, CEO Mike Mussallem said on a July 29 earnings call.

Overview of the dive:

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

“The delivery of the Pascal Precision System to clinicians in Europe marks another important milestone in our partnership with physicians who treat a large population of patients with mitral and tricuspid valve disease,” said Bernard Zovighian, Vice President of Transcatheter Therapies. mitral and tricuspid at Edwards, in a press release.

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

So far, most 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 underway. Edwards is seeking late 2022 approval in Europe for its Evoque tricuspid valve replacement system, although the process is “more uncertain” under the new medical device regulatory process, Zovighian said on the call for July 29 results.

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