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Infuse® Bone Graft

rhBMP-2/ACS

Instructions for Preparation and Handling

I N F U S E® B o n e G r a f t

INFUSE® Bone Graft

7510050 XX Small Kit (0.7cc)

Note: You will need to prepare a sterile and non-sterile field before beginning product preparation.

Total preparation time: Allow at least 15 minutes for preparation and an additional 15 minutes for protein to bind to collagen sponge.

(1) 5mL vial

(1) 1.05mg vial

(1) ACS ½" x 2" (1.25cm x 5.08cm) 0.7cc graft volume

IN NON-STERILE FIELD

1

Observing proper sterile technique, open the outer Absorbable Collagen Sponge (ACS) package and place the inner package containing the one

½"x2"collagenspongeinthesterilefield. Open and place one of the two 3mL syringes/needles into the sterile field.

0.9mL

0.9mL

2

3

4

Using the other 3mL syringe/

Reconstitute the rhBMP-2with

Gently swirl (do not shake)

needle, withdraw 0.9mL of sterile

0.9mL of sterile water.

the rhBMP-2 vial to ensure

water for injection.

 

adequate mixing. Inspect the

 

 

solution. If dark particles are

 

 

observed, do not use and return

 

 

to sponsor.

IN STERILE FIELD

0.7mL

0.7mL

 

on ACS

5

6

7

Open the inner ACS package leaving

In the sterile field use the 3mL

Uniformly distribute 0.7mL of

thecollagenspongeintheplastictray.

syringe/needle to withdraw 0.7mL

reconstituted rhBMP-2 on the

 

of reconstituted rhBMP-2 from

½" x 2" collagen sponge. Inspect

 

the vial held by the person in the

the sponge. If dark particles are

 

non-sterile field.

observed, do not use and return

 

 

to sponsor.

Allowwettedcollagenspongestostandforaminimumof15 minutes.

!Usewithin2hours.DONOTuseirrigationorsuctionnearimplanteddevice. Note:Duringhandlingavoidexcessivesqueezingofthewettedsponge.

2

INFUSE® Bone Graft

7510100 X Small Kit (1.4cc)

Note: You will need to prepare a sterile and non-sterile field before beginning product preparation.

Total preparation time: Allow at least 15 minutes for preparation and an additional 15 minutes for protein to bind to collagen sponge.

(1) ACS 1" x 2" (2.5cm x 5.08cm) 1.4cc graft volume

IN NON-STERILE FIELD

0.9mL

0.9mL

1

2

3

4

Observing proper sterile technique, open the outer ACS package and place the inner package containing the one 1" x 2" collagen sponge in the sterile field. Open and place two of the four 3mL syringes/needles into the sterile field.

Using one of the two remaining 3mL syringes/needles withdraw 0.9mL of sterile water for injection.

Reconstitute one vial of the rhBMP-2 with 0.9mL of sterile water.

Gently swirl (do not shake) the rhBMP-2 vial to ensure adequate mixing. Using a second 3mL syringe/ needle repeat steps 2 and 3 with the remaining vial of sterile water and vial of rhBMP-2. Inspect the solution in both vials. If dark particles are observed, do not use and return to sponsor.

IN STERILE FIELD

0.7 mL

0.7mL on ½

0.7mL

0.7mL on

ACS

 

½ ACS

5

6

7

8

9

Openthe innerACSpackage leavingthecollagenspongein theplastictray.

In the sterile field use the 3mL syringe/needle to withdraw 0.7mL of reconstituted rhBMP-2 from the first vial held by the person in the non- sterile field.

Uniformly distribute 0.7mL of reconstituted rhBMP-2 on half of the 1" x 2" collagen sponge.

In the sterile field use the second 3mL syringe/needle to withdraw 0.7mL of reconstituted rhBMP-2 from the second vial held by the person in the non- sterile field.

Uniformly distribute 0.7mL of reconstituted rhBMP-2 on the other half of the 1" x 2" collagen sponge. The total amount of reconstituted rhBMP-2 delivered to the sponge is 1.4mL. Inspect the sponge. If dark particles are observed, do not use and return to sponsor.

Allowwettedcollagenspongestostandforaminimumof15 minutes.

!Usewithin2hours.DONOTuseirrigationorsuctionnearimplanteddevice. Note:Duringhandlingavoidexcessivesqueezingofthewettedsponge.

r G e n o B ® S U FIN at f E

3

I N F U S E® B o n e G r a f t

INFUSE® Bone Graft

7510200 Small Kit (2.8cc)

Note: You will need to prepare a sterile and non-sterile field before beginning product preparation.

Total preparation time: Allow at least 15 minutes for preparation and an additional 15 minutes for protein to bind to collagen sponge.

(1) 5mL vial

(1) 4.2mg vial

(2) ACS 1" x 2" (2.54cm x 5.08cm) 2.8cc graft volume

IN NON-STERILE FIELD

1

Observing proper sterile technique, open the outer ACS package and place the inner package containing the two 1" x 2" collagen sponges in the sterile field. Open and place one of the two 5mL syringes/needles into the sterile field.

3.2mL

3.2mL

2

3

4

Using the other 5mL syringe/needle,

Reconstitute the rhBMP-2 with

Gently swirl (do not shake)

withdraw 3.2mL of sterile water

3.2mL of sterile water.

the rhBMP-2 vial to ensure

for injection.

 

adequate mixing.

IN STERILE FIELD

1.4mL

1.4mL on

1.4mL on

 

1st ACS

2nd ACS

5

 

 

6

7

8

 

 

 

 

 

 

Open the inner ACS package

In the sterile field use the 5mL

Uniformly distribute 1.4mL of

Using the same 5mL syringe/

leaving both collagen sponges

syringe/needle to withdraw 1.4mL

reconstituted rhBMP-2 on one of

needle, repeat steps 6 and 7 for the

in the plastic tray.

of reconstitutedrhBMP-2fromthe

the 1" x 2" collagen sponges.

remaining 1" x 2" collagen sponge.

 

 

 

vial held by the person in the

 

 

 

 

 

non-sterile field.

 

 

Allowwettedcollagenspongestostandforaminimumof15 minutes.

!Usewithin2hours.DONOTuseirrigationorsuctionnearimplanteddevice. Note:Duringhandlingavoidexcessivesqueezingofthewettedsponge.

4

INFUSE® Bone Graft

7510400 Medium Kit (5.6cc)

Note: You will need to prepare a sterile and non-sterile field before beginning product preparation.

Total preparation time: Allow at least 15 minutes for preparation and an additional 15 minutes for protein to bind to collagen sponge.

(2) 5mL vials

(2) 4.2mg vials

(4) ACS 1" x 2" (2.54cm x 5.08cm) 5.6cc graft volume

IN NON-STERILE FIELD

3.2mL

3.2mL

1

2

3

4

Observing proper sterile technique,

Using one of the two remaining 5mL

Reconstitute one vial of the rhBMP-2

Gently swirl (do not shake) the

open the outer ACS package and

syringes/needles, withdraw 3.2mL of

with 3.2 mL of sterile water.

rhBMP-2 vial to ensure adequate

place the inner package containing

sterile water for injection.

 

mixing. Using a second 5mL

the four 1" x 2" collagen sponges in the

 

 

syringe/needle, repeat steps 2

sterile field. Open and place two of

 

 

and 3 with the remaining vial of

the four 5mL syringes/needles into

 

 

sterile water and vial of rhBMP-2.

the sterile field.

IN STERILE FIELD

1.4mL

1.4mL on

1.4mL on

 

1st ACS

2nd ACS

5

 

 

6

 

 

7

 

 

8

Open the inner ACS package leaving

In the sterile field use the 5mL

Uniformly distribute 1.4mL of

Using the same 5mL syringe/

all collagen sponges in the plastic tray.

syringe/needle to withdraw 1.4mL

reconstituted rhBMP-2 on one of

needle, repeat steps 6 and 7 for

 

 

 

of reconstituted rhBMP-2 from the

the 1" x 2" collagen sponges.

the second 1" x 2" collagen sponge.

 

 

 

vial held by the person in the

 

 

 

 

 

 

 

non-sterile field.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1.4mL

 

1.4mL on

 

1.4mL on

 

 

 

 

 

3rd ACS

 

4th ACS

 

9

10

11

In the sterile field use the second 5mL

Uniformly distribute 1.4mL of

Using the second 5mL syringe/needle,

syringe/needle to withdraw 1.4mL

reconstituted rhBMP-2 on the

repeat steps 9 and 10 for

of reconstituted rhBMP-2 from the

third 1" x 2" collagen sponge.

the fourth 1" x 2" collagen sponge.

second vial held by the person in the

 

 

non-sterile field.

 

 

Allowwettedcollagenspongestostandforaminimumof15 minutes.

!Usewithin2hours.DONOTuseirrigationorsuctionnearimplanteddevice. Note:Duringhandlingavoidexcessivesqueezingofthewettedsponge.

r G e n o B ® S U FIN at f E

5

I N F U S E® B o n e G r a f t

INFUSE® Bone Graft

7510600 Large Kit (8.0cc)

Note: You will need to prepare a sterile and non-sterile field before beginning product preparation.

Total preparation time: Allow at least 15 minutes for preparation and an additional 15 minutes for protein to bind to collagen sponge.

IN NON-STERILE FIELD

1

Observing proper sterile technique, open the outer ACS package and place the inner package containing the six 1" x 2" collagen sponges in the sterile field. Open and place one of the two 10mL syringes/needles into the sterile field.

8.4mL

8.4mL

2

3

4

Using the other 10mL syringe/

Reconstitute the rhBMP-2 with

Gently swirl (do not shake)

needle, withdraw 8.4mL of sterile

8.4mL of sterile water.

the rhBMP-2 vial to ensure

water for injection.

 

adequate mixing.

IN STERILE FIELD

4.0mL

4.0mL on

4.0mL on 2nd

 

1st three ACS

three ACS

5

6

7

8

Open the inner ACS package leaving

In the sterile field use the 10mL

Uniformly distribute 4.0mL of

Using the same 10mL syringe/

all collagen sponges in the plastic tray.

syringe/needle to withdraw 4.0mL

reconstituted rhBMP-2 on three of

needle, repeat steps 6 and 7

 

of reconstituted rhBMP-2 from

the 1" x 2" collagen sponges.

for the remaining three 1" x 2"

 

the vial held by the person in the

 

collagen sponges.

 

non-sterile field.

 

 

Allowwettedcollagenspongestostandforaminimumof15 minutes.

!Usewithin2hours.DONOTuseirrigationorsuctionnearimplanteddevice. Note:Duringhandlingavoidexcessivesqueezingofthewettedsponge.

6

INFUSE® Bone Graft

7510800 Large II Kit (8.0cc)

Note: You will need to prepare a sterile and non-sterile field before beginning product preparation.

Total preparation time: Allow at least 15 minutes for preparation and an additional 15 minutes for protein to bind to collagen sponge.

IN NON-STERILE FIELD

1

Observing proper sterile technique, open the outer ACS package and place the inner package containing the 3" x 4" collagen sponge in the sterile field. Open and place one of the two 10mL syringes/needles into the sterile field.

8.4mL

8.4mL

2

3

4

Using the other 10 mL syringe/

Reconstitute the rhBMP-2 with

Gently swirl (do not shake)

needle, withdraw 8.4mL of sterile

8.4mL of sterile water.

the rhBMP-2 vial to ensure

water for injection.

 

adequate mixing.

IN STERILE FIELD

4.0mL

4.0mL on 1st

4.0mL on 2nd

 

half ACS

half ACS

5

6

7

8

OpentheinnerACSpackage.Using

In the sterile field use the 10mL

Uniformly distribute 4.0mL of

Using the same 10mL syringe/

sterile scissors, cut the 3" x 4"

syringe/needle to withdraw 4.0mL

reconstituted rhBMP-2 on one of the

needle, repeatsteps6and7forthe

collagenspongeintotwo1½" x 4"

of reconstituted rhBMP-2 from the

1½" x 4" collagen sponges.

remaining1½" x 4" collagen sponge.

strips. Return the cut collagen

vial held by the person in the

 

 

sponges to the plastic tray.

non-sterile field.

 

 

r G e n o B ® S U FIN at f E

Allowwettedcollagenspongestostandforaminimumof15 minutes.

!Usewithin2hours.DONOTuseirrigationorsuctionnearimplanteddevice. Note:Duringhandlingavoidexcessivesqueezingofthewettedsponge.

7

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR: INFUSE® BONE GRAFT/LT-CAGE® LUMBAR TAPERED FUSION DEVICE

INFUSE® BONE GRAFT/INTER FIX™ THREADED FUSION DEVICE

INFUSE® BONE GRAFT/INTER FIX™ RP THREADED FUSION DEVICE

The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1, who may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. The INFUSE® Bone Graft/ LT-CAGE® Lumbar Tapered Fusion Device is to be implanted via an anterior open or an anterior laparoscopic approach. INFUSE® Bone Graft with either the INTER FIX™ or INTER FIX™ RP Threaded Fusion Device is to be implanted via an anterior open approach.

The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device consists of two components containing three parts– a metallic spinal fusion cage, a recombinant human bone morphogenetic protein and a carrier/scaffold for the bone morphogenetic protein and resulting bone. Thesecomponentsmustbeusedasasystemfortheprescribedindicationdescribedabove. The bonemorphogeneticproteinsolutioncomponentmustnotbeusedwithoutthecarrier/scaffoldcomponentorwithacarrier/scaffoldcomponentdifferentfromtheonedescribedinthisdocument. The INFUSE® BoneGraftcomponentmustnotbeusedwithouttheMedtronicTitaniumThreadedInterbodyFusionDevicecomponent.

NOTE: The INTER FIX™ Threaded Fusion Device and the INTER FIX™ RP Threaded Fusion Device may be used together to treat a spinal level. LT-CAGE® Lumbar Tapered Fusion Device implants are not to be used in conjunction with either the INTER FIX™ or INTER FIX™ RP implants to treat a spinal level.

The INFUSE® Bone Graft/Medtronic Titanium Threaded Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor; in patients with any active malignancy or patients undergoing treatment for a malignancy; in patients who are skeletally immature; in pregnant women; or in patients with an active infection at the operative site or with an allergy to titanium or titanium alloy.

There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.

Pleaseseethepackageinsertforthecompletelistofindications,warnings,precautions,adverseevents,clinicalresults,definitionofDDD,andotherimportantmedicalinformation. Thepackageinsert alsomatchesthesizesofthosesizeddevicesthatareindicatedforusewiththeappropriateINFUSE® BoneGraftkit.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.

BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR: INFUSE® BONE GRAFT

INFUSE® Bone Graft is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management. INFUSE® Bone Graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.

INFUSE® Bone Graft consists of two components – recombinant human Bone Morphogenetic Protein-2 solution and a carrier/scaffold for the bone morphogenetic protein solution and resulting bone. These componentsmustbeusedasasystem. Thebonemorphogeneticproteinsolutioncomponentmustnotbeusedwithoutthecarrier/scaffoldcomponentorwithacarrier/scaffoldcomponentdifferentfrom theonedescribedinthisdocument.

INFUSE® Bone Graft is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with an active malignancy or patients undergoing treatment for a malignancy. INFUSE® Bone Graft should also not be used in patients who are skeletally immature, in patients with an inadequate neurovascular status, in patients with compartment syndrome of the affected limb, in pregnant women, or in patients with an active infection at the operative site.

There are no adequate and well controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of child bearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible orthopedic treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of child-bearing potential should be advised to not become pregnant for one year following treatment with this device.

Pleaseseethepackageinsertforthecompletelistofindications,warnings,precautions,adverseevents,clinicalresults,andotherimportantmedicalinformation. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician with appropriate training or experience.

BRIEFSUMMARYOFINDICATIONS,CONTRAINDICATIONS,WARNINGS,AND

PRECAUTIONFORINFUSE® BONE GRAFTFORCERTAINORALMAXILLOFACIAL ANDDENTALREGENERATIVEUSES

INFUSE® Bone Graft is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.

The INFUSE® Bone Graft consists of two components–recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an Absorbable Collagen Sponge (ACS). Thesecomponentsmustbeusedasa systemfortheprescribedindication.Thebonemorphogeneticproteinsolutioncomponentmustnotbeusedwithoutthecarrier/scaffoldcomponentorwithacarrier/scaffoldcomponentdifferentfrom theonedescribedinthepackageinsert.

INFUSE® Bone Graft is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy or patients undergoing treatment for a malignancy, in pregnant women, or patients with an active infection at the operative site.

There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of childbearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible dental treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of childbearing potential should be advised to not become pregnant for one year following treatment with this device.

INFUSE® Bone Graft has not been studied in patients who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure).

Pleaseseethepackageinsertforthecompletelistofindications,warnings,precautions,adverseevents,clinicalresults,andotherimportantmedicalinformation.

MEDTRONIC

Spinal and Biologics Business

Worldwide Headquarters

2600 Sofamor Danek Drive Memphis, TN 38132

1800 Pyramid Place

Memphis, TN 38132

(901) 396-3133

(800) 876-3133

Customer Service: (800) 933-2635

www.sofamordanek.com

www.infusebonegraft.com

For more informationgoto www.myspinetools.com

MLITINFPB8

IRN3426/068 REVIRN7238/078

©2008 Medtronic Sofamor Danek USA, Inc.

All Rights Reserved.

The surgicaltechnique shownis for illustrativepurposes only. The technique(s)actuallyemployedineach casewillalwaysdependupon themedical judgment ofthe surgeonexercised beforeandduring surgery as to thebest modeof treatmentfor eachpatient.