PASCAL Precision System (PASCAL Implant and PASCAL ACE Implant)
10 mm PASCAL and 6mm PASCAL ACE Implant
The PASCAL Precision system is intended to repair an insufficient mitral valve via percutaneous reconstruction through tissue approximation. 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.
Count and link only, sourced from the TGA's Database of Recalls, Product Alerts and Product Corrections. "Market actions" includes recalls, product alerts and product corrections — full detail stays on the TGA's own site.
No recorded changes yet — history accumulates with each release.
Data sourced from Australian Government publications · Not an official government service