Edwards Lifesciences

Develops transcatheter heart valves and devices

Edwards Lifesciences

Develops transcatheter heart valves and devices

Overview

Edwards Lifesciences focuses on cardiovascular medical technologies, especially transcatheter heart valves. Its products enable repairing or replacing diseased heart valves through minimally invasive procedures rather than open-heart surgery. The company builds on a long history that began with the Starr-Edwards valve and now centers on valve therapies and related diagnostics to treat heart disease. It differentiates itself by specializing in valve technologies and transcatheter approaches, backed by a track record of clinical leadership and global reach. The goal is to improve patient outcomes by providing safer, less invasive valve treatment options for people around the world.

Significant Headcount Growth

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About Edwards Lifesciences

Simplify's Rating

Why Edwards Lifesciences is rated

A-

Rated A on Competitive Edge

Rated A on Growth Potential

Rated B on Differentiation

Industries

Industrial & ManufacturingHealthcare

Company Size

10,001+

Company Stage

IPO

Headquarters

Irvine, California

Founded

1958

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Simplify's Take

What believers are saying

CMS finalized expanded TAVR coverage September 10, 2026, enlarging addressable Medicare volume.
Q2 2026 sales rose 13.6% to $1.74 billion; management raised full-year guidance.
AUTUS approval and ECLIPTIS launch broaden growth beyond mature TAVR programs.

What critics are saying

FTC settled July 2026 JC Medical charges for $10 million and compliance oversight.
January 2026 injunction blocked JenaValve buyout, crippling Edwards' aortic-regurgitation acquisition strategy.
AtriaCure, Medtronic, and Boston Scientific attack Edwards' adjacencies; failure here destroys diversification.

What makes Edwards Lifesciences unique

Edwards owns SAPIEN TAVR leadership and the 2025 asymptomatic-label exclusivity.
AUTUS, approved October 1, 2026, creates a pediatric pulmonary-valve franchise.
ECLIPTIS, cleared July 2026, extends Edwards into surgical stroke-prevention during cardiac surgery.

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Benefits

Performance Bonus

Stock Price

Growth & Insights and Company News

6 month growth

1 year growth

10%

2 year growth

10%

Business Wire

Oct 21st, 2026

FDA approves Edwards' PASCAL Precision system for tricuspid valve repair

Edwards Lifesciences has won US Food and Drug Administration (FDA) approval for its PASCAL Precision system to repair tricuspid valves. The system treats patients with symptomatic severe tricuspid regurgitation who remain unwell despite optimal medical therapy and face intermediate or greater surgical risk. The approval makes Edwards the only company in the US offering both repair and replacement transcatheter therapies for the mitral and tricuspid valves. The FDA also approved the PASCAL Ace with Capture Clarity system for mitral repair. It is the first approved device of its kind with fluoroscopic indicators that confirm when valve leaflets have been grasped. One-year data from the CLASP IITR pivotal trial will be presented at Transcatheter Cardiovascular Therapeutics.

WZUU

Oct 15th, 2026

FDA flags Edwards heart-valve delivery system issue after death, injury.

FDA flags Edwards heart-valve delivery system issue after death, injury. By Thomson Reuters Oct 15, 2026 | 6:38 PM Oct 15 (Reuters) - The US FDA on Thursday warned of a potentially high-risk issue involving certain Edwards Lifesciences delivery systems used in transcatheter mitral valve replacement after one death and one serious injury. The FDA said Edwards Lifesciences had asked customers to remove affected products from use and return them after receiving three reports of balloons bursting during inflation. The company reported one death and one serious injury associated with the issue as of October 5. The affected devices are certain Commander M delivery systems used with Edwards' SAPIEN M3 transcatheter mitral valve replacement system, which received US approval in December 2025. The FDA said balloon bursts could block blood vessels or prevent retrieval of the device, potentially requiring additional procedures, including surgery, in patients generally considered unsuitable for surgery. (Reporting by Sahil Pandey in Bengaluru; Editing by Anil D'Silva)

Business Insider

Oct 2nd, 2026

Edwards Lifesciences (EW) receives a Buy from RBC Capital.

Edwards Lifesciences (EW) receives a Buy from RBC Capital. Oct. 2, 2026, 09:46 PM RBC Capital analyst Kendall Au maintained a Buy rating on Edwards Lifesciences on October 1 and set a price target of $110.00. The company's shares closed yesterday at $85.19. Au covers the Healthcare sector, focusing on stocks such as Becton Dickinson, GE Healthcare Technologies Inc, and Boston Scientific. According to TipRanks, Au has an average return of -3.6% and a 22.22% success rate on recommended stocks. The word on The Street in general, suggests a Strong Buy analyst consensus rating for Edwards Lifesciences with a $103.40 average price target, representing a 21.38% upside. In a report released on September 28, Leerink Partners also reiterated a Buy rating on the stock with a $101.00 price target. Based on Edwards Lifesciences' latest earnings release for the quarter ending June 30, the company reported a quarterly revenue of $1.74 billion and a net profit of $241.9 million. In comparison, last year the company earned a revenue of $1.53 billion and had a net profit of $329.8 million Based on the recent corporate insider activity of 110 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of EW in relation to earlier this year. Most recently, in August 2026, Annette Bruls, the CVP, EMEACLA of EW sold 2,644.00 shares for a total of $237,907.12. Read More on EW:

Business Wire

Oct 1st, 2026

Edwards Lifesciences wins FDA approval for AUTUS, first surgical pulmonary valve for pediatric patients

Edwards Lifesciences has received FDA approval for the AUTUS Size-Adjustable Valve, the first surgical pulmonary valve designed specifically for paediatric patients with congenital heart disease. The valve can be expanded as a child grows through a minimally invasive transcatheter procedure, potentially reducing the need for repeat open-heart surgeries. The approval was based on a pivotal study that met its primary safety and effectiveness endpoints. All patients were free from device-related complications through 30 days, with no valve reinterventions through six months. Patients who completed one-year follow-up showed consistent outcomes with favourable valve performance. The AUTUS valve previously received FDA Breakthrough Device designation for addressing an important unmet need in paediatric cardiac care.

Yahoo Finance

Sep 8th, 2026

Edwards Lifesciences beats Q2 expectations, raises 2026 guidance despite lagging Dow by 5.7%

Edwards Lifesciences, an Irvine, California-based cardiovascular products company, has underperformed the Dow Jones Industrial Average in recent months. The stock is down 6.6% from its 52-week high of $96.29 reached on 7 July. Over the past three months, Edwards Lifesciences shares grew 2.8%, lagging the Dow's 3.5% gain. The 52-week performance shows similar underperformance, with the stock up 11.4% compared to the Dow's 17.1% increase. Despite this, the company reported strong Q2 results on 23 July, with net sales rising 13.6% year-over-year to $1.7 billion. Adjusted earnings per share of $0.78 beat Wall Street estimates. The company raised its 2026 sales growth guidance to 10-11% from 9-11% previously. Analysts maintain a "strong buy" consensus rating, with a mean price target suggesting 13.5% upside potential.

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