PASCAL Precision System – Implant System - Heart valve clip

Intended purpose

The PASCAL Precision system is intended to repair an insufficient mitral and/or tricuspid valve via percutaneous reconstruction through tissue approximation. The PASCAL Precision system percutaneously delivers the implant to the valve via a femoral vein access using a transvenous, transseptal (mitral) and transvenous (tricuspid) approach.

Functional description

The PASCAL Precision System is comprised of the Implant System and Guide Sheath. The Implant System consists of the Loader, Steerable Catheter, Implant Catheter and Implant which comes in two sizes: 10 mm and 6 mm. The 10 mm Implant is referred to as PASCAL Implant and the 6 mm Implant is referred to as PASCAL Ace Implant. The Guide Sheath consists of the Guide Sheath, Introducer and an additional Loader for user convenience.