Device typeAortic transcatheter heart valve bioprosthesis, stent-like framework: An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.
FDA categoryAortic Valve, Prosthesis, Percutaneously Delivered
Device ID00850000898127
Catalog numberTRILOGY-THV-L
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Size27MM