Device Description; Contraindications - Stryker Surpass Evolve Gebrauchsanweisung

Surpass Evolve™
Flow Diverter System
warnInG
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if
sterile barrier is damaged. If damage is found, call your Stryker Neurovascular
representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/or
lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.

DevIce DescrIptIon

The Surpass Evolve Flow Diverter System is comprised of a self-expandable
braided implant preloaded on a delivery wire, housed inside an introducer sheath.
The system consists of the following components:
• Surpass Evolve Flow Diverter (implant)
• Delivery wire and introducer sheath
• Optional torque device
surpass evolve Flow Diverter
The braided Surpass Evolve Flow Diverter is the implant portion of the system. It
is shipped pre-loaded on the delivery wire, inside the introducer sheath. These
devices come in different diameter and length combinations ranging from 2.5mm
to 5.0mm in diameter and from 12mm to 40mm in length. Interwoven with the
Surpass Evolve Flow Diverter cobalt chromium wires are platinum-tungsten wires
for visualization under fluoroscopy.
Once released from the constraint of the microcatheter into the vessel, the implant
expands to the vessel lumen diameter and can be recaptured and repositioned
prior to full deployment, if needed. In its expanded shape, the implant diverts the
blood flow away from the aneurysm.
Delivery wire and Introducer sheath
The implant is pre-loaded on the delivery wire and protected by an introducer
sheath. The flow diverter is located between the distal and proximal markers
on the delivery wire, which signal the distal and proximal ends of the implant.
The petal is designed to protect the distal end of the implant as it is advanced
through the microcatheter. The resheath pad allows the user to resheath the flow
diverter back into the microcatheter. The resheath marker provides the operator
fluoroscopic visualization of the resheathing limit of the implant. The distal 2cm of
the delivery wire, the distal tip, is radiopaque.
The introducer sheath consists of a polymer tube with a tapered distal end. It is
designed to protect the implant until it is transferred into the microcatheter.
Black (K) ∆E ≤5.0
Figure 1. surpass evolve Flow Diverter system
1. Delivery Wire 4. Resheath Marker
2. Proximal Marker 5. Flow Diverter
3. Resheath Pad 6. Petal
optional torque Device
The physician may attach the torque device to the proximal end of the delivery wire,
which may facilitate advancement through the microcatheter and deployment.
However, the delivery wire is not designed to be torqued.
accessories (not provided)
Standard interventional devices, including:
• Appropriately sized Sheath or Guide Catheter
• Appropriately sized Intermediate Catheter (recommended)
• Stryker Neurovascular Excelsior
Microcatheter with a 135cm or 150cm length
• Appropriately sized Guidewire
• Rotating hemostatic valves ≥ 4F (9F recommended)
• Sterile heparinized saline solution
The Surpass Evolve Flow Diverter System is designed specifically for use with a
Stryker Neurovascular Excelsior XT-27 Standard Straight Microcatheter.
Compatibility with other microcatheters has not been established.
IntenDeD Use/InDIcatIons For Use
The Surpass Evolve Flow Diverter System is indicated for use for the treatment of
saccular or fusiform intracranial aneurysms arising from a parent vessel with a
diameter ≥2.0mm and ≤5.0mm.

contraInDIcatIons

The Surpass Evolve Flow Diverter is contraindicated in the following patient types:
• Patients in whom the parent vessel size does not fall within the indicated
range.
• Patients in whom antiplatelet and/or anticoagulation therapy (e.g., aspirin and
clopidogrel) is contraindicated.
2
7. Distal Marker
8. Distal Tip
9. Introducer Sheath
XT-27 Standard Straight (0.027 in ID)
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