Consistently demonstrating the results you need for the outcomes that matter

SAPIEN valve technology: the valve design that has revolutionized how we treat severe symptomatic aortic stenosis today, leveraging decades of Edwards surgical valve innovation and expertise.

SAPIEN 3 transcatheter aortic valve replacement (TAVR) is proven superior* to surgery in low-risk patients at 1 year and proven equally effective at 5 years.1

Proven in the PARTNER 3 Low-Risk Trial

  • 8.5% death, stroke, rehospitalization versus 15.1% for surgery at 1 year*1
  • 22.8% death, stroke, rehospitalization versus 27.2% for surgery at 5 years*2

*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.

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%).

PVL and pacemaker rates similar to surgery at 1 and 5 years in low-risk patients1,2

Moderate or Severe PVL at 1 Year Moderate or Severe PVL at 5 Years New Permanent Pacemaker at 1 Year New Permanent Pacemaker at 5 Years
SAPIEN 3 0.6% 0.9% 7.3% 13.5%
Surgery 0.5% 0% 5.4% 10.4%

Consistently strong outcomes for a variety of patient morphologies:

  • Excellent clinical outcomes in low-risk bicuspid patients3
  • Consistently strong outcomes across indicated annular sizes4

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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 TAVR experience an implanter can count on, starting with the index procedure.

View the brochure

Designed to deliver a TAVR experience an implanter can count on

Edwards Commander delivery system

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

Edwards eSheath+ introducer set

Low profile and expandable sheath design

Edwards eSheath+ Introducer set

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

Edwards SAPIEN platform: The leading solution for lifetime management

Every patient—across all valve sizes and genders—deserves to be considered for comprehensive lifetime management.

See the new real-world data

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. Mack MJ, Leon MB, Thourani P, Transcatheter aortic valve replacement in low-risk patients at five years. N Engl J Med. 2023;10.1056/NEJMoa2307447. 3. 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. 4. 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.