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August 18, 2022

Edwards obtains CE Mark for transcatheter valve repair system

Including PASCAL and PASCAL Ace implants, the system has atraumatic clasp and closure as well as independent grasping.

Edwards Lifesciences has obtained CE Mark for its PASCAL Precision transcatheter valve repair system to treat mitral and tricuspid regurgitation (MR and TR).

The PASCAL Precision system has been designed for precise placement with accurate, intuitive control. It enables precise navigation and implant delivery.

The device is intended for use in the treatment of MR and TR patients through a single delivery system.

It comprises PASCAL and PASCAL Ace implants that have atraumatic clasp and closure, independent grasping, and implant versatility, along with the ability to navigate complex anatomies and elongate.

Using the PASCAL Precision system, surgeons can get predictable capture, positioning and release for patients with MR.

Additionally, the system helps in the treatment of challenging tricuspid anatomies in patients with TR.

Edwards transcatheter mitral and tricuspid therapies corporate vice-president Bernard Zovighian said: “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.

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 company stated that the PASCAL Precision system is one of many transcatheter repair or replacement therapies that it is developing to address mitral and tricuspid valve diseases.

It aims to transform the treatment of mitral and tricuspid patients.

In 2020, Edwards Lifesciences signed an agreement with Abbott to settle all outstanding patent disputes in cases related to transcatheter mitral and tricuspid repair products.

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