Edwards gains CE mark for Pascal Precision system for mitral and tricuspid regurgitation

Pascal Precision
Edwards Lifesciences’ Pascal Precision system

Edwards Lifesciences has announced that 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 utilised 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 Jörg Hausleiter (Ludwig-Maximilians University in Munich, 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 said in a press release.


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