Step
Procedure
8
At the discretion of the treating physician, if pressure
monitoring is used to continuously assess atrial pressure during
procedure, please follow the pressure monitor manufacturer's
instruction of use . Connect a fluid filled pressure monitoring
device to the steerable catheter . Aspirate and then calibrate at
the patient's heart level before obtaining measurement .
Note: Pressure monitoring should be used in
conjunction with echo. Pressure should be reconciled
with echo and Doppler readings. When assessing atrial
pressure, ensure that the distal tip of the Implant
Catheter is fully exposed from the Steerable Catheter.
9
Advance Implant System as needed . Manipulate Steerable
Catheter and Guide Sheath (flex-unflex, torque in opposing
directions, advance-retract) as needed until Implant is centered
in the target coaptation zone with the appropriate trajectory .
CAUTION: Excessive manipulation may result in
dislodgement or disturbance of a previously implanted
device, cardiac structure damage requiring surgical
repair, or other intervention.
Note: The radiopaque marker band on the Steerable
Catheter indicates the end of the flex section and can be
visualized on fluoroscopy.
10
Advance the Actuation Knob to get the Implant into Leaflet-
Capture-Ready position .
Note: For a tricuspid procedure, after placing implant in
Leaflet-Capture-Ready Position, pull the Slider Pin and
move one slider to identify which Implant Clasp it
controls via imaging and secure Slider Pin.
11
Torque the Implant Catheter, as needed, to orient the Paddles .
12
Advance the Implant through the valve until Paddles are below
the free edge of the leaflets .
13
Verify location and orientation of the Implant and adjust
position slightly as needed .
CAUTION: Excessive manipulation of the Implant below
the leaflets may cause the Implant to be entangled in
the chords; chordal entanglement may result in cardiac
injury, worsening regurgitation, difficulty or inability to
remove the Implant requiring additional intervention.
14
Under imaging guidance, retract the Implant until leaflets are
positioned between Paddles and Clasps .
15
Advance Slider(s) so the leaflet(s) are secured between the
Clasps and Paddles .
This can be performed for both leaflets simultaneously (Slider
Pin engaged to move both Clasps) or each leaflet individually
(Slider Pin disengaged to move individual Clasp) .
16
Verify leaflet insertion with imaging .
If leaflets are not secured between Clasps and Paddles, retract
the Sliders to release the leaflets and reattempt .
17
Once leaflets are secured between the Clasps and Paddles, close
the Implant .
18
Advance Implant Catheter slightly to release tension on leaflets .
Step
Procedure
19
Assess regurgitation, and reposition as needed . Once the
Implant position is confirmed, ensure Implant is closed .
If repositioning within the ventricle is needed, retract the
Sliders and advance the Actuation Knob to set the Implant in
Leaflet-Capture-Ready position . Adjust Clasps and Implant
orientation as needed .
If repositioning within the atrium is needed, retract the Sliders
and advance the Actuation Knob to elongate the Implant slowly
under fluoroscopic guidance while ensuring that the Actuation
Wire does not bend, and retract the Implant back into
the atrium .
CAUTION: Failure to elongate the Implant when
retracting into the atrium during repositioning may
result in leaflet damage or chordal entanglement.
CAUTION: Failure to release leaflets from Clasps and
Paddles prior to repositioning may result in
leaflet damage.
20
To release the Implant from the catheter:
a) Ensure that the distal tip of the Implant Catheter is fully
exposed from the Steerable Catheter .
b) Cut outside suture on the proximal end of each Slider .
Open both Slider Stopcocks to unlock sutures . Pull the
Slider Pin to fully remove sutures .
c) Close both Slider Stopcocks after removal of sutures .
d) Remove the Release Pin . Rotate counterclockwise and
retract the Release Knob until the Implant is released, as
confirmed via imaging .
Note: Prior to Implant release, if needed, it is possible to
retrieve the Implant System back into the Guide Sheath
for removal. To retrieve:
a) Retract the Sliders .
b) Elongate the Implant slowly under fluoroscopic guidance
while ensuring that the Actuation Wire does not bend .
Then retract Implant into the atrium . Set the Implant in
Closed position .
c) Unflex the Steerable Catheter and retract the Implant
System until the Implant is adjacent to the tip of the
Guide Sheath .
d) Advance the Sliders .
e) Set the Implant in Elongated position .
f) Retract the Sliders to open the Clasps to approximately 45°
on each side .
g) Retract entire Implant System through the Guide Sheath .
6