Edwards SAPIEN 3 Instructions For Use Manual
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Edwards SAPIEN 3 Instructions For Use Manual

Transcatheter heart valve with the edwards commander delivery system
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Edwards SAPIEN 3 Transcatheter Heart Valve
with the Edwards Commander Delivery System
Instructions for Use
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
Implantation of the transcatheter heart valve should be performed only by physicians who have
received Edwards Lifesciences training. The implanting physician should be experienced in
balloon aortic valvuloplasty.
Please verify that you have the latest version of the instructions for use prior to using the device
by visiting http://THVIFU.edwards.com or by calling 1.800.822.9837. In order to access the
instructions for use, an IFU Code will be required.
STERILE: The valve is supplied sterilized with glutaraldehyde solution. The delivery system,
eSheath introducer set, and crimper are supplied sterilized with ethylene oxide gas.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, EDWARDS COMMANDER,
Edwards eSheath, Edwards SAPIEN, Edwards SAPIEN 3, eSheath, PARTNER, PARTNER II, Qualcrimp,
SAPIEN, SAPIEN 3, TFX, and ThermaFix are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
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  • Page 1 Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, EDWARDS COMMANDER, Edwards eSheath, Edwards SAPIEN, Edwards SAPIEN 3, eSheath, PARTNER, PARTNER II, Qualcrimp, SAPIEN, SAPIEN 3, TFX, and ThermaFix are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
  • Page 2 • Edwards Commander Delivery System (Figure 2) The Edwards Commander delivery system is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve and consists of a Flex Catheter to aid in valve alignment to the balloon, tracking, and positioning of the valve.
  • Page 3 Refer to the Edwards Crimper instructions for use for device description. Indications The Edwards SAPIEN 3 transcatheter heart valve, Model 9600TFX, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥...
  • Page 4 For more information about glutaraldehyde exposure, refer to the Material Safety Data Sheet available from Edwards Lifesciences. • To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon.
  • Page 5 “unfolding” and tortuosity of the thoracic aorta Access characteristics that would preclude safe placement of 14F or 16F Edwards eSheath Introducer Set, such as severe obstructive calcification or severe tortuosity Bulky calcified aortic valve leaflets in close proximity to coronary ostia 6.0 Potential Adverse Events...
  • Page 6 • Bleeding • Anemia • Abnormal lab values (including electrolyte imbalance) • Hypertension or hypotension • Allergic reaction to anesthesia, contrast media, or device materials • Hematoma • Syncope • Pain or changes at the access site • Exercise intolerance or weakness •...
  • Page 7 Inflation devices provided by Edwards Lifesciences Edwards Crimper 9600CR Includes the Qualcrimp Crimping Accessory,2-piece Crimp Stopper and loader ** Or other compatible sheath provided by Edwards Lifesciences Additional Equipment: • 20 cc syringe or larger (x2) • 50 cc syringe or larger •...
  • Page 8 Attach a 3-way stopcock to the balloon inflation port. Partially fill a 50 cc or larger syringe with 15-20 mL diluted contrast medium and attach to the 3-way stopcock. Fill the inflation device provided by Edwards Lifesciences with excess volume relative to the indicated inflation volume. Lock the inflation device and attach to the 3-way stopcock.
  • Page 9 Close the stopcock to the 50 cc or larger syringe. Remove the syringe. Verify that the inflation volume is correct and lock the Inflation device provided by Edwards Lifesciences. CAUTION: Maintain the Inflation device provided by Edwards Lifesciences in the locked position until valve deployment.
  • Page 10 Advance the Edwards Commander delivery system, with the Edwards logo facing up, through the sheath until the valve exits the sheath. Retract the loader to the proximal end of the delivery system. NOTE: Maintain the proper orientation of the flex catheter (with the Edwards logo facing up) throughout the procedure.
  • Page 11 Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode) Under the scan conditions defined above, the SAPIEN 3 transcatheter heart valve is expected to produce a maximum temperature rise of 3.0 ºC after 15 minutes of continuous scanning.
  • Page 12 SAPIEN 3 Intermediate Risk Cohort: The PIIS3i Cohort of the PARTNER II trial was a single arm, non- randomized, historical-controlled study to compare TAVR with the Edwards SAPIEN 3 valve system to the surgical aortic valve replacement (SAVR) arm from the previous PARTNER II trial Cohort A (PIIA-SAVR) in patients who were judged by a heart team to be at intermediate risk for open surgical therapy.
  • Page 13 PARTNER II SAPIEN 3 HIGH-RISK/INOPERABLE COHORT Accountability All 583 eligible patients were successfully implanted with a SAPIEN 3 valve, which constitutes the Valve Implant (VI) population. Among the VI population, 491 patients were implanted via the transfemoral (TF) access route, and 92 patients via the transapical (TA) or transaortic (TAo) access route.
  • Page 14 The composite rate of all-cause mortality, all stroke, and AI ≥ moderate at 30 days was 6.7% in the SAPIEN 3 cohort and 15.6% in the SAPIEN cohort, as shown in Table 7. The resulting proportion difference in the average treatment effect on the treated (ATT; [2]) was -6.9% (90% CI: [-13.3%, -0.5%]).
  • Page 15 The Wald-type two-sided 90% confidence interval using weighted mean and SD is provided The Kaplan-Meier (K-M) estimates for all-cause mortality, cardiac mortality, and all stroke at 30 days for the SAPIEN 3 cohort and the SAPIEN cohort are provided in Table 8. Table 8: Death and Stroke at 30 Days –...
  • Page 16 SAPIEN 3 Valve (PIIS3HR VI Population) vs. SAPIEN Valve The proportion of patients with AI ≥ moderate at 30 days was 3.0% in the SAPIEN 3 cohort and 14.3% in the SAPIEN cohort, which were found to be statistically significantly different (p=0.0051; Table 9).
  • Page 17 0.0051, which was less than 0.025. As such, the null hypothesis was rejected for AI ≥ moderate at 30 days, indicating that the SAPIEN 3 cohort was superior over the SAPIEN cohort in regards to AI ≥ moderate at 30 days.
  • Page 18 Table 11: Secondary Endpoints for Labeling – SAPIEN 3 Valve vs. SAPIEN Valve (VI Population) Original Endpoints Inference p-value Major Vascular > 0.05; reject the alternative Complications at 30 0.0578 hypothesis. Proceed to the rest of Days testing AI at 30 Days 0.0051...
  • Page 19 Valve Performance The mean EOA increased from 0.7 ± 0.2 cm at baseline to 1.6 ± 0.4 cm at 30 days, as shown in Figure 5. Figure 5: Effective Orifice Area (PIIS3HR VI Population) Baseline 30 Day The average mean gradient decreased from 45.5 ± 14.3 mmHg at baseline to 11.1 ± 4.5 mmHg at 30 days, as shown in Figure 6.
  • Page 20 The mean peak gradient decreased from 75.8 ± 22.6 mmHg at baseline to 21.2 ± 8.5 mmHg at 30 days, as shown in Figure 7. Figure 7: Peak Gradient (PIIS3HR VI Population) 75.8 21.2 Baseline 30 Day The proportion of patients with AI ≥ moderate was 7.3% at baseline and 3.0% at 30 days, as shown in Figure 8.
  • Page 21 The proportion of patients with aortic paravalvular leak (PVL) ≥ moderate was 2.9% at 30 days, as shown in Figure 9. Figure 9: Aortic Paravalvular Leak (PIIS3HR VI Population) None Trace Mild Mild-Moderate Moderate Moderate-Severe Severe 30 Day NYHA The NYHA class by visit is shown in Figure 10. For all patients, the mean NYHA class was 3.2 ± 0.6 at baseline and 1.7 ±...
  • Page 22 The S3OUS study was a non-randomized, prospective, multi-center study in inoperable, high surgical risk, and intermediate surgical risk patients who underwent implantation of the 23, 26, or 29 mm SAPIEN 3 valve. Except the intermediate surgical risk patients, the inclusion/exclusion criteria of the S3OUS trial were largely similar to those of the PIIS3HR trial.
  • Page 23 A total of 56 patients were successfully implanted with a SAPIEN 3 valve via the transfemoral access route, and 45 via the transapical/transaortic access route, as shown in Table 13.
  • Page 24 Table 14: Patient Demographics and Baseline Characteristics (S3OUS AT Population) SAPIEN 3 SAPIEN 3 Valve SAPIEN 3 Valve Demographics and Baseline Valve Transfemoral Non-Transfemoral Characteristics Overall Access Access (N = 102) (N = 57) (N = 45) Coronary-artery bypass grafting 24 (23.5%)
  • Page 25 Table 15: CEC Adjudicated Adverse Events at 1 Year (S3OUS AT Population) 30 Day 1 Year SAPIEN 3 SAPIEN 3 SAPIEN 3 SAPIEN 3 Valve SAPIEN 3 Valve SAPIEN 3 Valve Valve Non- Outcomes Valve Non- Valve Transfemoral Transfemoral Transfemoral...
  • Page 26 Figure 11: All-Cause Mortality at 1 Year (S3OUS AT Population) Note: The confidence intervals are calculated without multiplicity adjustment. The adjusted confidence intervals could be wider than presented here. As such, confidence intervals are provided to illustrate the variability only and should not be used to draw any statistical conclusion.
  • Page 27 Figure 12: All Stroke at 1 Year (S3OUS AT Population) Note: The confidence intervals are calculated without multiplicity adjustment. The adjusted confidence intervals could be wider than presented here. As such, confidence intervals are provided to illustrate the variability only and should not be used to draw any statistical conclusion.
  • Page 28 The average mean gradient decreased from 44.8 ± 15.4 mmHg at baseline to 10.4 ± 4.1 mmHg at 30 days and maintained at 10.7 ± 4.1 mmHg at 1 year, as shown in Figure 14. Figure 14: Mean Gradient (S3OUS VI Population) 44.8 44.8 44.8...
  • Page 29 Figure 16: Aortic Insufficiency (S3OUS VI Population) None Trace Mild Mild-Moderate Moderate Moderate-Severe Severe Baseline 30 Day 1 Year The proportion of patients with aortic PVL ≥ moderate was 3.7% at 30 days, and 1.6% at 1 year, as shown in Figure 17. Figure 17: Aortic Paravalvular Leak (S3OUS VI Population)
  • Page 30 Table 16 presents patient accountability in the PIIS3i and PIIA-SAVR cohorts. Of the 1,074 eligible patients (Eligible Patient or EP Population) in PIIS3i, 1,069 were successfully implanted with a SAPIEN 3 valve and constitute the PIIS3i Valve Implant (VI) population. Among the VI population, 943 patients were implanted via the transfemoral (TF) access route, and 126 patients via a non-transfemoral (non-TF;...
  • Page 31 Study Population Demographics and Baseline Parameters The demographics of the PIIS3i and PIIA-SAVR EP populations are summarized in Table 17. Table 17: Patient Demographics and Baseline Characteristics of the EP Population SAPIEN 3 Valve Demographics & PIIA-SAVR Overall TF Only...
  • Page 32 Table 17: Patient Demographics and Baseline Characteristics of the EP Population SAPIEN 3 Valve Demographics & PIIA-SAVR Characteristics Overall TF Only Non-TF Only (N=938) (N = 1074) (N = 948) (N=126) 0/938 Porcelain aorta 1/1074 1/948 0/126 (0.0%) (0.1%) (0.1%) (0.0%)
  • Page 33 The Kaplan-Meier (KM) estimates for all-cause death and all stroke at 1 year for the PIIS3i cohort and the PIIA-SAVR cohort are provided in Table 19, as well as Figures 20 and 21, respectively. Table 19: All-Cause Death and All Stroke at 1 Year (VI Population) SAPIEN 3 Valve PIIA-SAVR (N= 1069) (N = 936) Propensity Score...
  • Page 34 Figure 20: All-Cause Death through 1 Year (VI Population) Note: The confidence intervals were calculated without multiplicity adjustment. The adjusted confidence intervals could be wider than presented here. As such, the confidence intervals are provided to illustrate the variability only and should not be used to draw any statistical conclusion. Figure 21: All Stroke through 1 Year (VI Population) Note: The confidence intervals were calculated without multiplicity adjustment.
  • Page 35 Therefore, for each of the secondary endpoints for labeling, the SAPIEN 3 valve was non-inferior to SAVR. Table 21: Secondary Endpoints for Labeling – Gatekeeping/Hierarchical Method...
  • Page 36 Adverse Events The key CEC-adjudicated adverse events through 1 year for the EP population are presented in Table 22. Table 22: CEC-Adjudicated Adverse Events through 1 Year (EP Population) SAPIEN 3 Valve Events PIIA-SAVR Overall TF Only Non-TF Only...
  • Page 37 Table 22: CEC-Adjudicated Adverse Events through 1 Year (EP Population) SAPIEN 3 Valve Events PIIA-SAVR Overall TF Only Non-TF Only Minor (non-disabling) stroke 18/1074 (1.7%) 17/948 (1.8%) 1/126 (0.8%) 16/938 (1.7%) Myocardial infarction 3/1074 (0.3%) 3/948 (0.3%) 0/126 (0.0%) 17/938 (1.8%) Major vascular complication 65/1074 (6.1%)
  • Page 38 In the PIIA-SAVR EP population, the mean duration in the operating room was 333.2 ± 96.4 min, the mean total procedure time was 237.5 ± 86.58 min, and the mean anesthesia time was 333.5 ± 108.42 min. General anesthesia was used in all patients. Valve Performance The measurements of EOA, mean gradient, peak gradient, total aortic regurgitation (AR), and aortic paravalvular leak (PVL) are presented in Figures 24-28.
  • Page 39 Figure 26: Peak Gradient (VI Population) Figure 27: Total Aortic Regurgitation (VI Population) Figure 28: Aortic Paravalvular Leak (VI Population)
  • Page 40 NYHA The NYHA classifications by visit are presented in Figure 29. In PIIS3i, 72.6% of the patients were in NYHA Class III or IV at baseline, which reduced to 6.3% at 30 days and 6.7% at 1 year, while in PIIA-SAVR, the percentage of patients in NYHA Class III or IV was 76.0% at baseline, 13.6% at 30 days, and 6.7% at 1 year.
  • Page 41 Six-Minute Walk Test (6MWT) The improvements in mean 6MWT distance are presented in Table 24. As compared to the SAPIEN 3 patients, the PIIA-SAVR patients had a decrease in mean 6MWT distance from baseline to 30 days. Table 24: 6MWT Distance (EP Population)
  • Page 42 133.8 Plus–minus values are means ± SD. Length of Stay (LoS) The results for LoS are presented in Table 25. Overall, the SAPIEN 3 patients had shorter LoS' than the PIIA-SAVR patients. Table 25: Length of Stay (EP Population) SAPIEN 3 Valve...
  • Page 43 Figure 32: KCCQ Clinical Summary Score - TF versus non-TF Access (EP Population)
  • Page 44 The results of the VAS and SF-36 measures are presented in Tables 26 and 27, respectively. Table 26: EQ-5D Visual Analog Scale (EP Population) SAPIEN 3 Valve EQ-5D Visual Analog Scale PIIA-SAVR...
  • Page 46 08/2016 ©Copyright 2016, Edwards Lifesciences LLC All rights reserved. Web IFU Manufacturer 10001354002 A Edwards Lifesciences LLC Telephone 949.250.2500 One Edwards Way 800.424.3278 Irvine, CA 92614 USA 949.250.2525...

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