Edwards PASCAL Manual Del Usuario página 4

Step Procedure
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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.
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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.
CAUTION: Failure to cut suture in prescribed location may result in
inability to release implant or introduction of fiber that may lead to
micro-embolism.
CAUTION: Failure to follow prescribed release steps may result in
difficulty or inability to release Implant, requiring additional
intervention.
CAUTION: Releasing the Implant prior to confirmation that leaflets
are securely captured between Paddles and Clasps may result in
Implant movement or dislodgement leading to a single leaflet
device attachment (SLDA) or other potential adverse events
requiring additional intervention.
WARNING: Re-use of the devices (including Implant System and
Guide Sheath) after retrieval may cause embolism of foreign
material or infection. Device may malfunction if re-use is
attempted.
Note: If an additional implant is placed at the decision of the
treating physician, caution should be taken to avoid dislodgement
of the previously placed implant. Crossing the valve in a low profile
implant configuration can minimize interaction with the previously
placed implant.
CAUTION: Excessive manipulation may result in dislodgement or
disturbance of a previously implanted device, cardiac structure
damage requiring surgical repair or other intervention.
7.4.4 Device Removal and Closure
Step Procedure
1 Retract Implant Catheter completely into Steerable Catheter. Gradually
unflex and remove Implant System. Gradually unflex and remove Guide
Sheath.
CAUTION: Failure to unflex devices prior to removal may result in
vessel damage.
2 Perform standard percutaneous closure of access site.
8.0 Magnetic Resonance (MR) Safety
Non-clinical testing has demonstrated that the PASCAL implant is MR Conditional. A patient with
this device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic fields of 1.5 T and 3.0 T
• Maximum spatial field gradient of 3,000 gauss/cm (30 T/m)
• Maximum MR system-reported, whole body averaged specific absorption rate (SAR) of
4 W/kg (First Level Controlled Operating Mode).
Under the scan conditions defined above, the Implant is expected to produce a maximum
temperature rise of less than 4 C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device in a worst case multiple implant
configuration extends up to 15 mm from the implant when imaged in the worst case gradient
echo pulse sequence in a 3.0 T MRI system.
9.0 Recovered Implant and Device Disposal
Edwards Lifesciences is interested in obtaining recovered clinical specimens of the Implant for
analysis. A written report summarizing our findings will be provided upon completion of our
evaluation. Please contact Edwards for return of the recovered Implant.
If you do decide to return any of the devices, please follow the following instructions:
• Unopened Package with Sterile Barrier Intact:
If the pouches have not been opened, return the device in its original packaging.
• Package Opened but Not Implanted:
If a pouch is opened, the device is no longer sterile. Please return the device in its original
packaging.
Explanted Implant:
•
The explanted implant should be placed into a suitable histological fixative such as 10%
formalin or 2% glutaraldehyde and returned to Edwards.
9.1 Disposal
Used devices may be handled and disposed of in the same manner as hospital waste and bio-
hazardous materials in accordance with local regulations as there are no special risks related to
the disposal of these devices.
10.0 Summary of Clinical Experience
10.1 CLASP Study
Clinical data in this section includes information obtained from the CLASP clinical study which
studied the PASCAL transcatheter valve repair system in the mitral valve.
A multi-center, multi-national, prospective, single-arm study (CLASP) was conducted to assess the
safety, performance, and clinical outcomes of the PASCAL system. All enrolled study patients were
assessed for clinical follow-up at 30 days, 6 months, 1 year, and will continue annually for 5 years
post-implant procedure.
The primary safety endpoint of the CLASP study was a composite of major adverse events (MAEs)
at 30 days. The MAEs include: cardiovascular mortality, stroke, myocardial infarction, new need for
renal replacement therapy, severe bleeding, and re-intervention for study device-related
complications.
The primary performance endpoints of the study include device success, procedural success, and
clinical success. The secondary endpoints of the study include clinical, safety, and functional
outcomes at 30-day, 6 month, 1 year, and annual follow-up time points.
Device success is defined as device deployment as intended and successful delivery system
retrieval as intended at the time of the patient s exit from the cardiac catheterization laboratory.
Analysis of device success was performed per device.
Procedural success is defined as device success with MR severity ≤ 2+ at discharge (Echo Core
Lab-evaluated) and without the need for a surgical or percutaneous intervention prior to hospital
discharge. Procedural success was analyzed per patient.
Clinical success is defined as procedural success with evidence of MR reduction MR ≤ 2+ and
without MAEs at 30 days (analyzed per patient).
An independent core lab assessed all echocardiographic data. An independent clinical events
committee (CEC) adjudicated safety events and a data safety monitoring board (DSMB)
independently reviewed aggregate safety data and evaluated trends of adverse events and their
effect on trial conduct and device risk assessment.
10.1.1 CLASP Study Results
The mean age of the patients treated was 75.4 years and 55.0% were male. All patients had NYHA
Class II, III or IV heart failure. The mean Logistic EuroSCORE I, EuroSCORE II and STS Mortality Score
were 14.4%, 5.8% and 4.7%, respectively. At baseline, 50.9% had moderate-severe MR, and 48.1%
had severe MR.
10.1.2 Performance
The performance endpoint included three components of success: device, procedural, and
clinical. Device success was achieved in 92.0% of devices attempted. Procedural success was
achieved in 93.5% of patients. Clinical success was achieved in 86.0% of patients.
10.1.3 Safety
At 30 days, the composite MAE rate was 8.0%. Nine patients experienced 11 MAEs prior to 30-day
follow-up. The CEC Adjudicated MAE at 30 Days by Counts are shown below.
Major Adverse Event (MAE)
Cardiovascular Mortality
Stroke
Myocardial Infarction
New Need for Renal Replacement Therapy
Severe Bleeding
Re-Intervention for Study Device Related
Complications
Composite MAE Rate
Note: Categorical measures - % (n/Total no)
In the overall population, MR grade reduction (i.e. MR ≤ 2+) was observed in 95.3% of patients at
discharge, 96.1% at 30 days, 98.8% at 6 months, and 100% at 1 year.
10.1.4 Study Conclusion
The data collected in the CLASP study supports the safety and performance of the PASCAL system
in patients with mitral regurgitation. The number of patients with follow-up of one year or more is
limited and long-term follow-up data is collected by means of a Post Marketing Clinical Follow-up
study.
10.2 CLASP TR Study
Clinical data in this section includes information obtained from the tricuspid clinical study (CLASP
TR) of the PASCAL transcatheter valve repair system.
A prospective, single arm, multi-center study (CLASP TR) was conducted to assess the safety,
performance, and clinical outcomes of the PASCAL system. All enrolled study patients were
assessed for clinical follow-up at 30 days, 6 months, 1 year, and will continue annually for 5 years
post-implant procedure.
The primary safety endpoint of the CLASP TR study was a composite of major adverse events
(MAEs) at 30 days. The MAEs include: cardiovascular mortality, myocardial infarction, stroke, renal
complications requiring unplanned dialysis or renal replacement therapy, severe bleeding,
unplanned or emergency re-intervention (either percutaneous or surgical) related to the device,
and major access site and vascular complications requiring intervention.
The primary performance endpoints of the study include device success, procedural success, and
clinical success. The secondary endpoints of the study include clinical, safety, and functional
outcomes at 30-day, 6-month, 1-year, and annual follow-up time points.
Device success is defined as device deployed as intended and successful delivery system retrieval
as intended at the time of the patient s exit from the cardiac catheterization laboratory. Analysis
of device success was performed per device.
Procedural success is defined as device success with evidence of a reduction in TR grade by at
least one grade (scale: non/trace, mild, moderate, severe, massive, torrential) at the end of the
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Summary Statistics
0.9% (1/112)
0.9% (1/112)
0.0% (0/112)
0.0% (0/112)
7.1% (8/112)
0.9% (1/112)
8.0% (9/112)