Edwards SAPIEN 3

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In non-clinical testing, the image artifact caused by the device extends as far as 14.5 mm from the implant
for spin echo images and 30 mm for gradient echo images when scanned in a 3.0T MRI system. The
artifact obscures the device lumen in gradient echo images.
The implant has not been evaluated in MR systems other than 1.5 or 3.0T.
10.0 Patient Information
Patient education brochures are provided to each site and should be given to the patient to inform them of
the risks and benefits of the procedure and alternatives in adequate time before the procedure to be read
and discussed with their physician. A copy of this brochure may also be obtained from Edwards
Lifesciences by calling 1.800.822.9837. A patient implant card request form is provided with each
transcatheter heart valve. After implantation, all requested information should be completed on this form.
The serial number may be found on the package and on the identification tag attached to the transcatheter
heart valve. The original form should be returned to the Edwards Lifesciences address indicated on the form
and upon receipt, Edwards Lifesciences will provide an identification card to the patient.
11.0 Recovered Valve and Device Disposal
The explanted valve should be placed into a suitable histological fixative such as 10% formalin or 2%
glutaraldehyde and returned to the company. Refrigeration is not necessary under these circumstances.
Contact Edwards Lifesciences to request an Explant Kit.
Used delivery system may be disposed of in the same manner that hospital waste and biohazardous
materials are handled. There are no special risks related to the disposal of these devices.
12.0 Clinical Studies
SUMMARY OF PRIMARY CLINICAL STUDY
The PARTNER II Trial Overview, SAPIEN 3 Valve
SAPIEN 3 High Risk and Inoperable Cohort: The SAPIEN 3 High Risk and Inoperable Cohort of the
PARTNER II trial (PIIS3HR) was a single arm, non-randomized, historical-controlled study to compare the
third generation Edwards SAPIEN 3 valve system with the first generation Edwards SAPIEN valve system
in patients who either have high risk for surgery or cannot undergo surgery (inoperable). The valve sizes
used in the PIIS3HR trial included only the 23, 26 and 29 mm sizes. The 20 mm valve size was
introduced into the trial after enrollment was completed with the three larger sizes, thus a separate nested
registry, NR7, with identical inclusion/exclusion criteria as the PIIS3HR Cohort except for the aortic
annulus diameter, was created to collect data for the 20 mm valve. Data from the PIIS3HR cohort and
NR7 are pooled for the statistical analyses. For convenience, this combined cohort is referred to as
“PIIS3HR” hereafter.
The database included 583 eligible patients enrolled at 29 investigational sites in the U.S.
The study used an independent Data Safety Monitoring Board (DSMB) that was instructed to notify
Edwards Lifesciences of any safety or compliance issues, a Clinical Events Committee (CEC) that was
responsible for adjudicating endpoint related events reported during the trial per a priori established
VARC 2 definitions
[1]
, an ECG core laboratory for independent analysis of rhythm, and an
echocardiographic core laboratory for independently analyzing all echocardiograms.
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. The
valve sizes used in the PIIS3i study included the 20, 23, 26, and 29 mm sizes.
Patients in PIIS3i were treated between February 2014 and September 2014. Patients in PIIA-SAVR
were treated between January 2012 and November 2013. The database reflected data collected through
December 10, 2015 and included 1,078 patients in PIIS3i enrolled at 51 investigational sites in the U.S
and 1,021 patients in PIIA-SAVR enrolled at 57 investigational sites in the U.S.