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Edwards Lifesciences raises 2026 guidance after third-quarter sales climb 10.5% to $1.72bn

🇺🇸 Edwards Lifesciences Corp (EW) · Wed 04 Nov 2026

The heart-valve maker cites TAVR and TMTT growth, several recent FDA and European approvals, and CMS's final updated TAVR coverage determination.

Edwards Lifesciences reported a 10.5% rise in sales to $1.72bn for the quarter ended 30 September 2026. The company also raised its full-year guidance for both sales and adjusted earnings per share.

Growth was led by two product groups. Sales of transcatheter aortic valve replacement (TAVR) products rose 8.0%, while sales in the transcatheter mitral and tricuspid therapies (TMTT) business increased 44.0%.

Edwards pointed to a run of regulatory milestones. In the US, the FDA has approved PASCAL Precision for tricuspid use, as well as PASCAL Ace with Capture Clarity and AUTUS. In Europe, SAPIEN M3 with RESILIA tissue has received approval.

The company also highlighted the Centers for Medicare & Medicaid Services' final updated national coverage determination for TAVR. The summary available does not give details of the changes, the revised guidance figures or the dates of the individual approvals.

What it means for your team

  • Market-access teams should review the final CMS TAVR national coverage determination, since it sets the reimbursement framework for the procedure in the US Medicare programme.
  • Regulatory teams tracking structural heart devices can note the FDA tricuspid approval for PASCAL Precision and the European approval for SAPIEN M3 as recent reference points.
  • The 44.0% TMTT growth indicates continued commercial uptake of transcatheter mitral and tricuspid therapies, which may increase post-market surveillance activity in the category.

Company's press release (SEC filing): Edwards Lifesciences Corp ↗

Article written by VigiEye from the official source (Edwards Lifesciences Corp). Claims are the company's own. AI-assisted; check the source before acting.

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