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Step
Procedure
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Before deployment, ensure that the THV is correctly
positioned between the Valve Alignment Markers and the
Flex Catheter tip is over the Triple Marker.
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Begin THV deployment:
a) Unlock the inflation device.
b) Ensure hemodynamic stability is established and begin
rapid pacing; once arterial blood pressure has
decreased to 50 mmHg or below, balloon inflation can
commence.
c) Using slow controlled inflation, deploy the THV with the
entire volume in the inflation device, hold for 3 seconds
and confirm that the barrel of the inflation device is
empty to ensure complete inflation of the balloon.
d) Deflate the balloon. When the balloon catheter has
been completely deflated turn off the pacemaker.
7.4.4 System Removal
Step
Procedure
1
Unflex the delivery system while retracting the device. Verify
that the Flex Catheter tip is locked over the Triple Marker.
Retract the loader to the proximal end of the delivery
system. Remove the delivery system from the sheath.
Note: For subclavian-axillary approach, keep delivery
system inside sheath until ready to remove all devices
as one unit.
CAUTION: Completely unflex the delivery system prior
to removal to minimize the risk of vascular injury.
7.5 Verification of Prosthetic Valve Position and Measurements
Measure and record hemodynamic parameters.
Step
Procedure
1
Perform an angiogram to evaluate device performance and
coronary patency, where applicable.
2
Measure and record the transvalvular pressure gradients.
3
Remove all devices when the ACT level is appropriate
(e.g., reaches < 150 sec).
Refer to the Edwards sheath instructions for use for device
removal.
4
Close the access site.
8.0 How Supplied
STERILE: The valve is supplied sterilized with glutaraldehyde solution.
The delivery system and accessories are supplied sterilized by ethylene oxide
gas.
The THV is supplied nonpyrogenic packaged in buffered glutaraldehyde, in a
plastic jar to which a tamper evident seal has been applied. Each jar is
shipped in a shelf box containing a temperature indicator to detect exposure
of the THV to extreme temperature. The shelf box is enclosed in Styrofoam
prior to shipping.
8.1 Storage
The THV must be stored at 10 °C to 25 °C (50 °F to 77 °F). Each jar is shipped
in an enclosure containing a temperature indicator to detect exposure of the
THV to extreme temperature.
The delivery system and accessories should be stored in a cool, dry place.
9.0 MR Safety
MR Conditional
Non-clinical testing has demonstrated that the Edwards SAPIEN 3
transcatheter heart valve is MR Conditional. A patient with this device can be
scanned safely, immediately after placement of this device under the
following conditions:
• Static magnetic field of 1.5 tesla (T) or 3 tesla (T)
• Maximum spatial gradient field of 2500 Gauss/cm (25 T/m) or less
• Maximum MR system reported, whole body averaged specific absorption
rate (SAR) of 2.0 W/kg (Normal Operating Mode).
Under the scan conditions defined above, the transcatheter heart valve is
expected to produce a maximum temperature rise of 3.0 °C after 15 minutes
of continuous scanning.
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 T or 3.0 T.
For valve-in-valve implantation or in the presence of other implants, please
refer to the MRI safety information for the surgical valve or other devices
prior to MR imaging.
10.0 Patient Information
A patient registration form is provided with each THV. After implantation,
please complete all requested information. The serial number may be found
on the package and on the identification tag attached to the THV. Return the
original form to the Edwards Lifesciences address indicated on the form and
provide the temporary identification card to the patient prior to discharge.
11.0 Clinical Studies
SAPIEN 3 THV FOR PATIENTS AT LOW SURGICAL RISK- STS/ACC
TRANSCATHETER VALVE THERAPY REGISTRY (TVTR) ANALYSIS
A database extract was performed on May 2020, which yielded 9,479
patients treated with an Edwards SAPIEN 3 transcatheter heart valve placed
in a native aortic valve (via subclavian/transaxillary or transfemoral access).
The patients were treated between July 16, 2015 and April 29, 2020. The
procedure was performed in 592 participating hospitals.
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