Edwards Scores Significant Regulatory Nod in Europe

Edwards Lifesciences has scored a CE mark for its Pascal Precision transcatheter valve repair system 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, corporate vice president of transcatheter mitral and tricuspid therapies at Edwards. "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 used to treat 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, a 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.