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• During delivery system preparation, ensure that the red safety clip remains in place until the stent is ready to be deployed. If the red

safety clip has been removed or becomes inadvertently detached from the grip, D

o N

T use the device.

9..5

Seelleeccttiioon

n ooff D

Deep

pllooyym

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Meetth

hood

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• Determine whether you will use the P

RFFo

X®® G

Grriip

p for stent deployment. (See instructions for “Stent Deployment with the

ERFoR

MAXX® Grip”, Section 9.8.)

• If selecting “The Conventional Method” of stent deployment, this option must be selected at the beginning of the procedure. (See

instructions for “The Conventional Method”, Section 9.9).

• If the P

RFFo

X®® G

Grriip

p is removed from the stent delivery system, it M

T N

T be reattached. In this event, the stent M

T be

deployed using “The Conventional Method” of deployment.

• A removable red Safety Clip ((K

K)) prevents accidental or premature stent release.

• D

o N

T remove the Safety Clip ((K

K)) until you are ready to deploy the stent.

• Just prior to deploying the stent, the Safety Clip ((K

K)) must be removed by pressing the two red tabs ((LL)) together and removing the

clip from the grip. ((S

Seeee FFiig

urree A

2))

9..6

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Stteen

ntt D

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• Insert the guidewire into the distal tip of the catheter until it exits the catheter at the proximal end of the device.
• Advance the delivery catheter over the guidewire into the target lumen. ((S

Seeee FFiig

urree A

5,, A

6,, A

7 aan

d A

8))

• Under fluoroscopic visualization, advance the stent delivery system across the stricture using the radiopaque markers to center the

stent across the lesion. ((S

Seeee FFiig

urree A

1))

• It is recommended to advance the delivery system past the stricture and then to pull back slightly on the entire system to achieve

the correct positioning of the markers and to help insure that slack has been removed and that the delivery catheter is straight.

• Prior to stent deployment, remove all slack from the catheter delivery system to avoid stent misplacement.
• D

o N

T hold the delivery system catheter during stent deployment. ((S

Seeee FFiig

urree A

3//A

4))

9..7

Stteen

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• During stent deployment, the entire length of the catheter system should be kept as straight as possible. Maintaining a straight

catheter under slight tension during stent deployment is recommended to improve placement accuracy.

• Center the proximal stent markers (S

Seeee FFiig

urree A

1, “B2”) and both overlapping distal markers (S

Seeee FFiig

urree A

1, stent markers “B1”

and marker band on the outer catheter “C”) across the stricture. The radiopaque markers on the stent indicate the ends of the
compressed stent and the length of the expanded stent.

• By initially advancing the catheter beyond the stricture, micro-adjustments of the stent can be made by pulling the entire system

back toward the stricture to improve placement accuracy.

• once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should N

T be dragged or

repositioned in the lumen.

• once stent deployment has been initiated, the stent C

T be recaptured using the stent delivery system.

• once the moving marker has passed the proximal end of the stent by approximately 2 cm, the stent is completely deployed.
• Complete stent deployment can be fluoroscopically visualized when the radiopaque markers at the proximal and distal ends of the

stent are fully expanded.

9..8

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hee P

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p::

• There are three different stent deployment options with the P

RFFo

X®® G

Grriip

– “The Trigger Method” ((S

Seeee S

Seeccttiioon

n 3

3..3

3,, FFiig

urree 1

1))

– “The Slide Method” ((S

Seeee S

Seeccttiioon

n 3

3..3

3,, FFiig

urree 2

2))

– “The Combination Method (Trigger/Slide)”

• Switching from “The Trigger Method” to “The Slide Method” can be done at any time during stent deployment; however, switching

from “The Slide Method” to “The Trigger Method” M

T be avoided.

• D

o N

T remove the Safety Clip ((K

K)) until you are ready to deploy the stent.

• Just prior to stent deployment, remove the red Safety Clip ((K

K)) by pressing the two red tabs ((LL)) together and removing the clip from

the grip. ((S

Seeee FFiig

urree A

2))

• Under fluoroscopic visualization, deploy the stent utilizing your chosen method of deployment until the stent is fully deployed and

the slide mechanism has reached the proximal end of the handle. ((S

Seeee FFiig

urree A

9 –

– A

1))

• During stent deployment ((S

Seeee FFiig

urree A

2)), the moving radiopaque marker (C) on the outer catheter moves backwards toward the

proximal markers on the stent (B2). The radiopaque markers on the stent (B1, B2) M

T N

T move during stent deployment.

• After stent deployment, carefully withdraw the delivery system from the patient over the guidewire. After removing the delivery

system, visually confirm that the entire stent delivery system has been removed. ((S

Seeee FFiig

urree A

3))

(a) inner catheter
(b) outer catheter
(c) moving distal marker (C) on outer catheter

• Final radiological evaluation of the implanted stent should be conducted by angiogram.

9..9

Stteen

ntt D

Deep

pllooyym

meen

ntt U

Ussiin

g T

hee C

Coon

nvveen

nttiioon

naall M

Meetth

hood

d::

• In addition to the three deployment options outlined in Section 9.8 there is also an option to release the stent W

WIIT

T the

RFFo

X®® G

Grriip

– “The Conventional Method” ((S

Seeee S

Seeccttiioon

n 3

3..3

3,, FFiig

urree 3

3))

• To allow "The Conventional Method" of deployment, remove the white conversion tab ((M

M)) from the back of the grip. ((S

Seeee FFiig

urree A

4))

• Separate the P

RFFo

X®® G

Grriip

p from the delivery system catheter by grasping the Luer lock ((E

E)) at the back end of the handle and

gently twisting to snap the catheter out of the back of the grip. ((S

Seeee FFiig

urree A

5)) Then grasp the deployment system at the front T-Luer

adapter ((FF)) and snap the deployment system completely out of the grip. ((S

Seeee FFiig

urree A

6)) Use caution not to bend the metal portion

of the catheter during removal from the grip.

• D

o N

T remove the Safety Clip ((K

K)) until you are ready to deploy the stent.

• Just prior to stent deployment, remove the red Safety Clip ((K

K)) by pressing the two red tabs ((LL)) together and removing the clip from

the grip. ((S

Seeee FFiig

urree A

7))

• Under fluoroscopic visualization, deploy the stent using the conventional “pin & pull-back” technique by slowly pulling back the T-Luer

adapter ((FF)) towards the hand that is pinned in place. Pulling back on the T-Luer adapter ((FF)) directly retracts the outer catheter and
deploys a corresponding portion of the stent. ((S

Seeee FFiig

urree A

8))

• Full stent deployment is ensured when the T-Luer adapter ((FF)) reaches the metal handle. ((S

Seeee FFiig

urree A

9))

• During stent deployment ((S

Seeee FFiig

urree A

2)), the moving radiopaque marker (C) on the outer catheter moves backwards toward the

proximal markers on the stent (B2). The radiopaque markers on the stent (B1, B2) M