Cardiology CE Mark Structural Heart

Europe allows Edwards’ Sapien 3 TAVR system in low-risk patients

Dive Brief:

  • Edwards Lifesciences’ Sapien 3 transcatheter heart valve is now allowed for use in Europe in patients at low risk for complications in open heart surgery, the medtech said Wednesday.
  • The CE mark expanding the indication for the Edwards technology follows an FDA decision in August to authorize the use of transcatheter aortic valve replacement systems from Edwards and competitor Medtronic in low-risk U.S. aortic stenosis patients.
  • Edwards said it is the first such system to achieve the low-risk indication in Europe.

Dive Insight:

Edwards saw a 26% increase in sales of its transcatheter aortic valve replacement, or implentation, systems during its most recent quarter, helping the Irvine, California-based company rake in $700 million.

“In Europe, Edwards’ growth was in the teens and we estimate that our competitive position was stable,” CEO Mike Mussallem said on an Oct. 23 earnings call. “Although transcatheter valves have been commercially available for over a decade in Europe, it’s encouraging to note that demand remains strong.”

Medtronic estimated in August there are 165,000 low-risk aortic stenosis patients throughout the U.S., Europe and Japan. Edwards did not estimate in its press release the number of new individuals who may now be eligible to receive its system under the expansion.

Both Medtronic and Edwards presented data on use of their TAVR systems in low-risk patients at the American College of Cardiology meeting in March. Edwards touted its Partner 3 trial, in which Sapien 3 use in low-risk patients led to superior outcomes when assessing all-cause mortality, stroke and one-year rehospitalization compared to patients undergoing open heart surgery.

Helge Möllmann, a cardiology expert at St. Johannes Hospital in Germany, said in Edwards’ announcement Wednesday that the European approval allows patients to be considered for the device based on “anatomical considerations or other individual needs rather than risk scores.”

Edwards also highlighted data from a company-backed study at the Transcatheter Cardiovascular Therapeutics symposium in September indicating low-risk patients saw substantially greater quality-of-life benefits a month after implantation. Those benefits continued at six months.

According to Medtronic, its third-generation Evolut Pro system was approved in Europe for extreme-, high- and intermediate-risk patients in 2017.


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