# Edwards Lifesciences PASCAL Trial Beats Medical Therapy at Six Months

> Edwards Lifesciences' PASCAL trial met its six-month primary endpoint, with 80% of treated patients at or below moderate tricuspid regurgitation at one year.

- Published: 2026-11-02T18:43:42+00:00
- Section: Research & Clinical Trials
- Author: News Desk
- URL: https://newsforagent.com/news/2026-11-02/edwards-lifesciences-pascal-trial-results
- Source: [TradingView](https://www.tradingview.com/news/tradingview:1116985ee62ef:0-edwards-lifesciences-corporation-ew-pascal-trial-shows-80-reached-moderate-tr/)

## Key takeaways

- Edwards Lifesciences said PASCAL was superior to medical therapy at the CLASP II TR trial's six-month primary endpoint.
- At one year, 80% of treated patients versus 30% of controls had at most moderate tricuspid regurgitation.
- The FDA approved PASCAL for tricuspid repair in October 2026, before the trial results were announced.

Edwards Lifesciences said its PASCAL device was superior to medical therapy at the six-month primary endpoint of the CLASP II TR trial. At one year, 80% of treated patients versus 30% of controls had at most moderate tricuspid regurgitation, and quality-of-life scores improved 18 points, [TradingView](https://www.tradingview.com/news/tradingview:1116985ee62ef:0-edwards-lifesciences-corporation-ew-pascal-trial-shows-80-reached-moderate-tr/) reported. The FDA approved PASCAL for tricuspid repair in October 2026.

## Inside the CLASP II TR Results

[Edwards Lifesciences](https://akta.pro/company-profiles/0006opv/edwards-lifesciences) designs and sells transcatheter and surgical heart valve therapies, including the SAPIEN, PASCAL and EVOQUE platforms, to hospital systems and cardiac care centers treating structural heart disease. The company said the trial met superiority over medical therapy at its six-month primary endpoint.

At the one-year mark, the share of treated patients with at most moderate tricuspid regurgitation was 80%, against 30% for controls. Quality-of-life scores rose 18 points among treated patients. The release provided no control-group comparison for that quality-of-life figure and no prior-period comparison for the regurgitation rates.

The results follow the FDA's October 2026 approval of PASCAL for tricuspid repair, which the company announced separately. The release gives no sales or adoption figures for the device.

## Edwards' Structural Heart Refocus

According to akta.pro [company records](https://akta.pro/company-data), Edwards completed the sale of its Critical Care product group to Becton, Dickinson and Company for $4.2 billion in April 2026, refocusing on structural heart as its core growth platform. The same records list more than 500,000 patients treated globally with Edwards heart valve technologies and annual revenue above $6.0 billion. Edwards appointed Theodora 'Doretta' Mistras as Corporate Vice President and Chief Financial Officer in May 2026, succeeding Scott Ullem, who had served as CFO since 2014.

## Earlier PASCAL and TAVR Milestones

In October 2026, Stock Titan reported that Edwards received FDA approval for its PASCAL Precision system for tricuspid valve repair and the PASCAL Ace with Capture Clarity for mitral TEER. Earlier the same month, Stock Titan reported FDA approval for the AUTUS Size-Adjustable Valve, described as the first surgical pulmonary valve for pediatric patients with congenital heart disease. On November 2, 2026, TradingView reported that the PROGRESS trial showed TAVR superiority over clinical surveillance in moderate aortic stenosis patients with at-risk features.

## Edwards' November 2 Investor Event

Stock Titan reported in October 2026 that Edwards would host an investor event on November 2 in conjunction with the TCT scientific symposium in San Diego, including a live Q&A with physicians and management and a webcast on the company's investor relations website.

## Companies in this story

- [Edwards Lifesciences company profile](https://akta.pro/company-profiles/0006opv/edwards-lifesciences) · website: http://www.edwards.com

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