References:
1. Tarantini G, Fovino LN, Le Prince P, et al. Coronary access and percutaneous coronary intervention up to 3 years after transcatheter aortic valve implantation with a balloon-expandable valve. Circ Cardiovasc Interv. 2020;13(7):e008972.
2. Tarantini G, et al. Redo-Transcatheter aortic valve implantation using the SAPIEN 3/Ultra transcatheter heart valves – Expert Consensus on Procedural Planning Techniques, The American Journal of Cardiology, 2023
3. Ochiai T, Oakley L, Sekhon N, et al. Risk of coronary obstruction due to sinus sequestration in redo transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2020;13(22):2617-2627. doi:10.1016/j.jcin.2020.09.022.
4. De Backer O, Landes U, Fuchs A, et al. Coronary Access After TAVR-in-TAVR as Evaluated by Multidetector Computed Tomography. JACC Cardiovasc Interv. 2020;13(21):2528-2538.
5. Edwards Lifesciences SAPIEN 3/Ultra valve Instructions for Use.
6. Makkar RR, et al. Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study. Lancet. 2023 Aug 31:S0140-6736(23)01636-7.
7. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380:1695-1705.
8. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. 2023.
No clinical data are available to evaluate the long-term impact of RESILIA tissue in patients. Additional clinical data for up to 10 years of follow-up are being collected to monitor the long-term safety and performance of RESILIA tissue.
Medical device for professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).