Your first move defines the next

A unique design built for consistent outcomes

Your first move defines the next

A unique design built for consistent outcomes

Consistently demonstrating the results you need for the outcomes that matter1,9

The Edwards SAPIEN 3 valve design has revolutionized how we treat severe aortic stenosis today, leveraging decades of Edwards surgical valve innovation and expertise.

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
  • 8.5% death, stroke, rehospitalization versus 15.1% for surgery at 1 year*1

*In the PARTNER 3 trial, SAPIEN 3 TAVI 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.

Supported by outstanding outcomes, the SAPIEN 3 platform 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 patients2
  • Consistently strong outcomes across indicated annular sizes3

The Edwards SAPIEN platform brochure

When it comes to lifetime management, learn more about how the Edwards SAPIEN 3 platform is designed to deliver a TAVI experience an implanter can count on, starting with the index procedure.

View the brochure

Designed to deliver a TAVI experience a Heart Team can count on

Edwards Commander delivery system

Predictability and control to meet the increasing complexity of your procedures.4

Instructions for use available on www.eifu.edwards.com.

Edwards eSheath+ introducer set5

Low profile and expandable sheath design

Edwards eSheath+ Introducer set

*16F & 6.0mm for 29mm SAPIEN 3 Valve

Outcomes

Consistent outcomes that matter, starting with the index procedure.1

Explore outcomes ›

Durability

A comprehensive approach to a durable therapy that offers proven long-term patient outcomes.6,9

Explore durability ›

Future Interventions

Making future options possible.7,8

Explore future options ›

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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. 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. 3. 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. 4. Thourani VH, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet. 2016 May 28;387(10034):2218-25. 5. Edwards Lifesciences SAPIEN 3/Ultra valve Instruction for Use. 6. Pibarot P, Ternacle J, Jaber WA, et al. Structural deterioration of transcatheter versus surgical aortic valve bioprosthesis in PARTNER-2 trial. J Am Coll Cardiol. 2020;76:1830-1843. 7. 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(7):e008972. 8. 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. 9. 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).