Plan your next move right from the start

Edwards SAPIEN platform: The choice for lifetime management

New PARTNER 3 trial 5 year data

Data from the PARTNER 3 trial continues to prove the Edwards SAPIEN 3 platform is the choice for lifetime management – from the index procedure and beyond.

  • Life: The only transcatheter heart valve with 1% death or disabling stroke at 1 year
  • Time: The only transcatheter heart valve with 90% survival at 5 years
  • Management: The only transcatheter heart valve with a THV-in-THV indication*
Visit NEJM to download View the clinical publication

*For patients assessed at high-risk for surgical replacement.

Consistently demonstrating the results you need for the outcomes that matter

With patients of all ages living longer and having high expectations for their quality of life, lifetime management is increasingly important. The first valve choice matters, and the Edwards SAPIEN 3 platform is designed to deliver a TAVI experience you can count on for all three essential components of lifetime management.

Consistently demonstrating the results you need for the outcomes that matter.1

A comprehensive approach to the durability that addresses the key drivers of reintervention.2

Making future options possible.3

Building on a legacy of superior outcomes

Proven in the landmark PARTNER clinical trials

  • Only SAPIEN 3 valve is proven superior to surgery* in low-risk patients
  • 1% death or disabling stroke at 1 year1

Supported by outstanding outcomes, SAPIEN 3 Ultra valve delivers at 1 year:1

1.0%

All-cause
mortality

(n=496)

0.2%

Disabling
stroke

(n=496)

0.6%

Moderate or severe
paravalvular
regurgitation

(n=496)

7.3%

Permanent
pacemaker
implantation

(n=496)
Baseline included

Consistently strong outcomes for a variety of patient morphologies:

  • Excellent clinical outcomes in low-risk bicuspid patients4
  • Consistently strong outcomes across indicated annular sizes5

*In the PARTNER 3 trial, SAPIEN 3 TAVR was proven superior to surgery on the primary endpoint of all-cause death, all stroke, and rehospitalization (valve-related or procedure-related, and including due to heart failure) at one year and multiple pre-specified secondary endpoints in low-risk patients.

A comprehensive approach to durability that addresses the key drivers of reintervention

‡Compared to SAPIEN 3 transcatheter heart valve.

Ready for the next intervention and beyond

Excellent performance for today's coronary access

100%

(68/68) success post-TAVR coronary access rate3

Preserving coronary access for future needs

2%

risk of future sinus sequestration¶9

Risk of sinus sequestration if (1) prior TAV commissure level above STJ and (2) the distance between TAV and STJ was <2.0mm in each coronary sinus.

The only platform approved and indicated for both TAV-in-TAV and TAV-in-SAV procedures10**

Primary endpoints of death and stroke for SAPIEN 3 TAVI (Native vs Redo)11

  • No statistical difference in death and stroke between redo SAPIEN 3 TAVR vs. native SAPIEN 3 TAVR at 1 year

** Patients assessed at high-risk for surgical replacement. Edwards Lifesciences SAPIEN 3/Ultra valve Instructions for Use.

Choose the Edwards SAPIEN 3 platform as your strategy for success in lifetime management.

References:

1. 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.
2. Pibarot P, Ternacle J, Jaber WA, et al. Structural deterioration of transcatheter versus surgical aortic valve bioprostheses in PARTNER-2 trial. J Am Coll Cardiol. 2020;76(16):1830-1843.
3. 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.
4. Williams MR, Jilaihawi H, Makkar R, et al. The PARTNER 3 bicuspid registry for transcatheter aortic valve replacement in low-surgical-risk patients. J Am Coll Cardiol Intv. 2022;15(5):523-32.
5. Eng MH, Abbas AE, Hahn RT, et al. Real world outcomes using 20 mm balloon expandable SAPIEN 3/ultra valves compared to larger valves (23, 26, and 29 mm)- a propensity matched analysis. Catheter Cardiovasc Interv. 2021;98(6):1185-92.
6. Tamm AR, et al. Minimizing Paravalvular Regurgitation With the Novel SAPIEN 3 Ultra TAVR Prosthesis: A Real-World Comparison Study.Front. Cardiovasc. Med. 8:623146, 2021
7. Edwards Lifesciences data on file.
8. 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 Interventions. 2021; 14:e010543.
9. 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.
10. Edwards Lifesciences SAPIEN 3/Ultra valve Instructions for Use.
11. 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.

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).

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, PARTNER, PARTNER II and PARTNER 3, are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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