Back to top

Image: Bigstock

Edwards Lifesciences (EW) Gets CE Mark for PASCAL Precision

Read MoreHide Full Article

Edwards Lifesciences Corporation (EW - Free Report) recently gained CE Mark for its PASCAL Precision transcatheter valve repair system used to treat mitral and tricuspid regurgitation. The PASCAL Precision system is one of several transcatheter repair or replacement therapies under development by Edwards Lifesciences to address mitral and tricuspid valve diseases.

This approval is likely to bolster Edwards Lifesciences’ transcatheter mitral and tricuspid therapies (TMTT) portfolio.

More on the News

The PASCAL Precision system treats mitral or tricuspid regurgitation through a single delivery system. The novel system is intended to facilitate precise navigation and implant delivery. It consists of the PASCAL and PASCAL Ace implants that enable independent grasping, atraumatic clasp and closure, and implant versatility, including the capacity to elongate and navigate complex anatomy.

Per management, bringing the PASCAL Precision system to clinicians in Europe represents a significant step in collaborating with physicians who treat a wide population of patients with mitral and tricuspid valve disease. The novel PASCAL Precision system features considerable advancements intended to enhance the clinicians' capacity to deliver positive results for patients with mitral and tricuspid regurgitation.

Industry Prospects

Per a report by Research and Markets, the valvular heart disease treatment market is expected to see a CAGR of roughly 8% during 2021-2027. The rising incidence of heart valve diseases, increasing research and development to develop treatment opportunities for valvular heart disease, government initiatives, regulatory endorsements for new and progressive prosthetic heart valves, among other factors, can be attributable to market growth.

Zacks Investment Research
Image Source: Zacks Investment Research

Given the market prospects, the latest regulatory approval for Edwards Lifesciences' PASCAL Precision system seems well-timed.

Other Developments in TMTT Business

Edwards Lifesciences has been making significant progress in its TMTT portfolio. The segment registered an improvement of 26.2% from the prior-year figure on a reported basis. On an underlying basis, the improvement was 38.3%. The upside was driven by the continued adoption of the PASCAL system and the activation of more centers across Europe.

In mitral replacement, the company continues to broaden its experience with both the transcatheter mitral replacement technologies through the ENCIRCLE pivotal trial for SAPIEN M3 and the MISCEND study for EVOQUE Eos. In terms of tricuspid, the company continues to make progress in enrolling its two tricuspid pivotal trials, the TRISCEND II pivotal trial for the EVOQUE system and the CLASS II TR pivotal trial with PASCAL in patients with symptomatic severe tricuspid regurgitation.

Share Price Performance

The stock has outperformed its industry in the past year. It has lost 16.3% compared with the 24.1% fall of the industry.

Zacks Rank and Key Picks

Currently, Edwards Lifesciences carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. (AMN - Free Report) , Molina Healthcare, Inc. (MOH - Free Report) and Patterson Companies, Inc. (PDCO - Free Report) .

AMN Healthcare has a long-term earnings growth rate of 3.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.7%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has outperformed its industry in the past year. AMN has gained 1.2% against the industry’s 28.8% fall.

Molina Healthcare has a long-term earnings growth rate of 16.4%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 3.2%, on average. It currently carries a Zacks Rank #2 (Buy).

Molina Healthcare has underperformed its industry in the past year. MOH has gained 25.3% against the industry’s 27.4% growth.

Patterson Companies has an estimated long-term growth rate of 7.9%. The company’s earnings surpassed estimates in all the trailing four quarters, the average beat being 16.5%. It currently flaunts a Zacks Rank #2.

Patterson Companies has outperformed its industry in the past year. PDCO has gained 0.6% compared with the industry’s 6.3% fall in the past year.

Published in