13
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 3.0 T 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 3.0 T.
For valve-in-surgical valve implantation or in the presence of other implants, please refer to MRI
safety information for the surgical valve or other devices prior to MR imaging.
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
The PARTNER II Cohort B Registries
Cohort B of The Placement of Aortic Transcatheter Valves Trial II (PARTNER II) included registries
for the transapical and transaortic delivery of the SAPIEN XT valve. These registries include the
following:
•
NR1: Inoperable Transapical (TA) Registry – transapical delivery of the 23 mm or
26 mm SAPIEN XT valve.
•
NR3: Registry for Transcatheter Heart Valve in Aortic Surgical Valve Implantation (THV-
SV). Patients with failing aortic bioprosthetic surgical valve with a surgical mortality or major
morbidity ≥ 50% and meeting the sizing requirements for 23 mm or 26 mm SAPIEN XT valve.
•
NR4: Inoperable Transaortic (TAo) Registry – transaortic delivery of the 23 mm or 26 mm
SAPIEN XT valve.
•
NR6: Inoperable Transapical Registry for the delivery of 29 mm SAPIEN XT valve in patients
that did not have eligible transfemoral access.
Following completion of enrollment in the nested registries, the FDA approved continued access
enrollment in the nested registries (CANRs).
SOURCE Registry XT
:
SOURCE Registry XT is an international multi-center prospective, consecutively enrolled,
observational registry. Consecutive patient data have been collected at discharge, 30 days, and 12
months post-implant, and will be collected annually thereafter up to 5 years post-implant.
Results of PARTNER II Cohort B Registries (NR1, NR4 and NR6)
A total of 265 patients were treated in PARTNER II Cohort B Nested Registries 1, 4, and 6. The
primary safety and effectiveness endpoint was freedom from all-cause mortality at 1 year. The KM
estimate at 30 days involving freedom from all-cause mortality was 92.0 ± 1.7%.