Edwards PASCAL Gebrauchsanweisung Seite 7

Step Procedure
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 4W/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) .
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