SAPIEN 3 TAVI is now approved for use in patients with severe aortic stenosis, independent of surgical risk.

With proven superiority to surgery,*1,2 SAPIEN 3 TAVI is establishing a new standard for the treatment of your severe aortic stenosis patients.

 

PARTNER 3 Trial demonstrates Edwards TAVI is superior to surgery.

1% at year graphic

At 1 year, SAPIEN 3 TAVI demonstrated 3x lower risk for composite of death or disabling stroke compared to surgery.

Death or Disabling Stroke Graph

Superior to surgery for the outcomes that matter most.*1,2

View 

30 days

View 

1 Year
PARTNER 3 Trial Clinical Events at 30 days
EventTAVI
(n= 496)
Surgery
(n= 454)
p-value
Primary Endpoints
Composite Primary Endpoint (death, stroke, rehospitalization)4.2%9.3%p=0.002³
All - cause Death0.4%1.1%p=0.21³
All stroke0.6%2.4%p=0.02³
Rehospitalization†3.4%6.5%p=0.04³
Secondary Endpoints
Major Vascular Complications2.2%1.5%p=0.45
Rehospitalization Due to Heart Failure³0.2%0.9%p=0.15
New Onset Atrial Fibrillation5.0%39.5%p<0.001
Life-threatening, Disabling, or Major Bleeding3.6%24.5%p<0.001
New Permanent Pacemaker6.5%4.0%p=0.09³
Discharged to Home/Self-care95.8%73.1%p<0.001³
Median Length of Hospitalization3 days7 daysp<0.001

TAVI outcomes at 30 days:

 

96% Discharged to home³
3 days Hospital stay

PARTNER 3 Trial Clinical Events at 1 Year
EventTAVI
(n= 496)
Surgery
(n= 454)
p-value
Primary Endpoints
Composite Primary Endpoint (death, stroke, rehospitalization)8.5%15.1%p=0.001
All - cause Death1.0%2.5%p=0.09
All stroke1.2%3.1%p=0.04
Rehospitalization†7.3%11.0%p=0.046
Secondary Endpoints
Major Vascular Complications2.8%1.5%p=0.19
Rehospitalization Due to Heart Failure³1.4%3.6%p=0.03
New Onset Atrial Fibrillation7.0%40.9%p<0.01
Life-threatening, Disabling, or Major Bleeding7.7%25.9%p<0.001
New Permanent Pacemaker7.3%5.4%p=0.21
Discharged to Home/Self-care---
Median Length of Hospitalization---

TAVI outcomes at 1 year:

 

1.4% Rehospitalization due to heart failure³

7.3% New pacemaker

You can now treat your patients with SAPIEN 3 TAVI, independent of their surgical risk.

Susan image SusanDavid image DavidPatricia image Patricia
AS Disease ProgressionSevere AS, symptoms include decreased exercise toleranceSevere AS, symptoms include fatigue, dyspnea upon exertionSevere AS, symptoms include reduced mobility and inability to walk short distances
Age/Gender73-year-old female81-year-old male88-year-old female
NYHA ClassIIIIIIII
Frailty Indicatiors0Passed 3 out of 4 with exception of grip testFailed 4/4
Surgical Risk Score (STS)2%6%10%
ComorbiditiesNoneDiabetes. High blood pressure. Previous PCI. No other comorbidities.Oxygen-dependent chronic obstructive pulmonary disease, hypertensions, and previous pacemaker implantation due to sick sinus syndrome.
QoL ExpectationsRetired nurse who enjoys frequent travel, working out, and bike rides. She looks forward to an extended life expectancy due to her age and active lifestyle.Semi-retired executive for an insurance company. Enjoys walking trails around his home and playing with his grandkids.Retired teacher, and requires assistance in daily life activities.
Low surgical riskIntermediate surgical riskHigh surgical risk
TAVI Patient TAVI Patient TAVI Patient

With more than a decade of evidence in randomised clinical trials, TAVI with the SAPIEN 3 System is now approved for use in patients with severe aortic stenosis, independent of surgical risk.

Give your low-risk patients the lowest risk procedure.