Device typeTricuspid transcatheter heart valve bioprosthesis: An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant tricuspid heart valve, or previously-implanted tricuspid heart valve prosthesis, and which is implanted using a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included with the device.
FDA categoryProsthesis, Tricuspid Valve, Percutaneously Delivered
Device ID00690103217445
Catalog number9850EV44US
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Outer Diameter44 Millimeter