Advanced calcium-blocking technology*1
SAPIEN 3 Ultra RESILIA valve
Building on the benefits of the SAPIEN 3 platform
SAPIEN 3 Ultra valve, powered by RESILIA tissue
Same tissue technology used in the #1 implanted surgical valve in the Canada
Potential to improve valve longevity and reduce reintervention*†1
The only transcatheter heart valve (THV) with dry tissue storage
*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients. †RESILIA tissue tested against tissue from commercially available bovine pericardial from Edwards Lifesciences in a juvenile sheep model. Flameng, et al. J Thorac Cardiovasc Surg.
29 mm valve extends paravalvular leak (PVL) outer skirt technology to larger-annulus patients
The SAPIEN 3 platform addresses the vital considerations for lifetime management
Building on the benefits of the SAPIEN 3 platform
Excellent outcomes in low-risk patients*
- 1% death and disabling stroke at one year2
- 90.9% none/trace PVL at discharge3
- 6.5% new pacemaker rate at 30 days2
Facilitates future treatment options
- 100% successful post-TAVR coronary access rate (68/68 patients)4
- The only valve with a THV-in-THV indication
Durability that stands up to SAVR in low risk patients†5
- SAPIEN 3 valve durability proven similar to SAVR at 5 years5
*The PARTNER 3 Trial, SAPIEN 3 TAVR proven superior to surgery on the primary endpoint of all-cause death, all stroke, and rehospitalization (valve-related or procedure-related and including heart failure) at one year, and multiple pre-specified secondary endpoints in low risk patients.
PARTNER 3 Trial 5-Year Results in Low-Risk Patients - Low rates of cardiovascular mortality through five years (5.5% SAPIEN 3 TAVR to 5.1% SAVR). Low rates of all-cause mortality through five years (10.0% SAPIEN 3 TAVR vs. 8.2% with SAVR). Low rates of disabling stroke through five years (2.9% SAPIEN 3 TAVR to 2.7% SAVR). Low rates of stroke through five years (5.8% SAPIEN 3 TAVR vs. 6.4% SAVR). Lower rates of rehospitalization with SAPIEN 3 TAVR through five years (13.7% vs. 17.4%).
Advanced calcium blocking technology*1
Stable-capping blocks calcium from binding to the tissue*1
*No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients
RESILIA tissue reduced calcification when compared to traditional surgical valve tissue treatments*1
Control valve (6900P)
RESILIA tissue valve
RESILIA tissue showed significant improvement in calcium-blocking properties
*RESILIA tissue tested against tissue from commercially available bovine pericardial valves from Edwards Lifesciences in a juvenile sheep model. Flameng, et al. J Thorac Cardiovasc Surg. 2015;149:340-345.
See the clinical evidence behind RESILIA tissue
Read the latest clinical trial results for aortic valve replacement with RESILIA tissue
References
- Flameng W, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149:340 -5.
- 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. doi:10.1056/NEJMoa1814052.
- Nazif TM, Cahill TJ, Daniels D, et al. Real-world experience with the SAPIEN 3 ultra transcatheter heart valve: a propensity-matched analysis from the United States. Circ Cardiovasc Interv. 2021;14:e010543.
- Tarantini G, Nai Fovino L, 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:e008972.
- Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic valve replacement in low-risk patients at five years. N Engl J Med. 2023;10.1056/NEJMoa2307447