EDWARDS PASCAL PRECISION TRANSCATHETER MITRAL AND TRICUSPID VALVE REPAIR SYSTEM RECEIVES CE MARK

Rhea-AI Summary

Edwards Lifesciences Corporation (NYSE: EW) announced its PASCAL Precision transcatheter valve repair system has received CE Mark approval for treating mitral and tricuspid regurgitation (MR and TR). This advancement enhances the company's partnership with physicians addressing valve disease. The PASCAL Precision system features innovative navigation and implant delivery, aiming to improve outcomes for patients. The system includes PASCAL and PASCAL Ace implants, designed for complex anatomies. Edwards remains committed to transforming valve disease treatment through clinical evidence.

Positive

• PASCAL Precision system received CE Mark approval, enabling market entry in Europe for treating MR and TR.
• Innovative design improves clinician experience and patient outcomes in valve repair.

Negative

• None.

IRVINE, Calif., Aug. 17, 2022 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), today announced the company's PASCAL Precision transcatheter valve repair system received CE Mark for the treatment of mitral and tricuspid regurgitation (MR and TR).

"Delivering the PASCAL Precision system to clinicians in Europe marks another significant step in our partnership with physicians who treat the large population of patients with mitral and tricuspid valve disease," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "Edwards has a long history of innovation, and the significant advancements in the PASCAL Precision system are designed to improve clinicians' ability to provide positive outcomes for patients with both MR and TR."

The PASCAL Precision system is utilized in the treatment of patients with mitral or tricuspid regurgitation, through a single delivery system. The new system is designed to enable precise navigation and implant delivery.

"The PASCAL Precision system provides significant advancements in operator experience with implant delivery," said Prof Jörg Hausleiter, Professor of Medicine and the Deputy Clinic Director at the Ludwig-Maximilians University in Munich, Germany. "Having successfully treated my first patient with the PASCAL Precision system, I found it easy to operate and the improved catheter response and stability gave me greater control to place the implant exactly where I needed to."

The PASCAL Precision system includes PASCAL and PASCAL Ace implants, which feature independent grasping, atraumatic clasp and closure, and implant versatility including the ability to elongate and navigate complex anatomy.

The PASCAL Precision system is one of multiple transcatheter repair or replacement therapies in development by Edwards that are designed to address mitral and tricuspid valve diseases. The company is committed to transforming the treatment of mitral and tricuspid patients, supported by a robust body of clinical evidence.

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2021, and its Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2022. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards PASCAL, Edwards PASCAL Precision, PASCAL, PASCAL Ace, and PASCAL Precision are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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SOURCE Edwards Lifesciences Corporation

FAQ

What is the PASCAL Precision system and its new approval?

The PASCAL Precision system is a transcatheter valve repair device that received CE Mark approval for treating mitral and tricuspid regurgitation.

How does the PASCAL Precision system improve treatment for valve disease?

It enhances navigation and implant delivery, aimed at better operator control and patient outcomes.

When was the CE Mark approval for the PASCAL Precision system announced?

The CE Mark approval was announced on August 17, 2022.

What are the benefits of the PASCAL Precision system over traditional methods?

The system offers improved operator experience, precise navigation, and the ability to address complex anatomy.

What commitment does Edwards Lifesciences have regarding valve disease treatment?

Edwards Lifesciences is committed to transforming treatment for mitral and tricuspid valve diseases through innovative solutions backed by clinical evidence.