MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Edwards Drops Centera to Focus on Sapien 3 Ultra Pixabay

Edwards Drops Centera to Focus on Sapien 3 Ultra

The Irvine, CA-based company launched a pivotal trial of the Centera valve in October of 2018.

Edwards Lifesciences said it is discontinuing work on its Centera Transcatheter Aortic Valve system. The Irvine, CA-based company said it will instead turn its attention and energy to the Sapien 3 Ultra Valve.

The news came during Edwards’ 2Q19 earnings call. The TAVR pioneer said the reason for halting the Centera program was due to the costs associated with expanding its indications to match the Sapien 3 valve.

“Given the pending approval for patients at low risk and the continued excellence and versatility of our balloon-expandable platform, we have made the difficult decision to discontinue the Centera program,” said Mike Mussallem, chairman and CEO of Edwards, according to a Seeking Alpha Transcript. “While the Centera valve has demonstrated excellent clinical outcomes and is performing well for patients, the time and resources required to optimize deliverability as well as expanding the indications to max Sapien 3 are significant. Going forward, we believe we best address patients’ needs by focusing resources on our robust pipeline of next-generation balloon-expandable technologies and indication expansion trials.”

Earlier last year, Edwards received CE mark for its Centera valve to treat severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. In October of 2018, the company launched a pivotal trial of the valve.

Centera could have softened the edge of some of Edwards’ competitors in the TAVR market. The firm is already dueling with Medtronic’s CoreValve. On top of that Boston Scientific is gearing up to launch its Lotus Edge valve, which won FDA approval in April.

“We know that Boston Scientific is in the process of launching and we expect that to have some impact,” Mussallem said, according to a Seeking Alpha Transcript of the call. “So those are going to be some headwinds.”

TAGS: Business News
Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.