Device typeMitral transcatheter heart valve bioprosthesis: An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant mitral heart valve, or previously-implanted mitral heart valve prosthesis, and which is implanted with 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.
FDA categoryProsthesis, mitral valve, percutaneously delivered
Device ID05415067032591
Catalog numberTENDV-LP-33S
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Outer Diameter33.0000 Millimeter