ACURATE Prime™ XL Nested Registry
- A non-randomized, nested registry cohort within the ACURATE IDE Clinical Trial that consists of subjects who will receive the ACURATE Prime™ Aortic Valve XL.
- There will be 50 subjects at up to 20 centers currently participating in the main ACURATE IDE Clinical Trial in the United States enrolled in this registry.
- Severe aortic valve stenosis.
- Subjects who have a documented aortic annulus size of ≥26.5 mm and ≤29 mm (perimeter-derived diameter) based on pre-procedure diagnostic imaging.
- All other criteria are the same as the main IDE cohorts.
ACURATE Prime™ Aortic Valve XL
- The ACURATE Prime™ Aortic Valve XL is an iteration of the CE Mark-approved ACURATE neo2™ Aortic Valve.
- The ACURATE Prime™ Aortic Valve XL allows easier removal of a fully loaded valve and is intended to optimize radial force with the addition of connected links.
|Valve Size||ACURATE Prime™ XL - 29mm|
|Aortic Annulus Perimeter Derived Diameter (mm)||26.5 < annulus ≤ 29|
|Aortic Annulus Perimeter (mm)||83 < annulus ≤ 91|