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SURGICAL TECHNIQUE GUIDE
CAVIMENDINFLATABLE BONE EXPANDER SYSTEM
Amendia
CavimendINFLATABLE BONE EXPANDER SYSTEM
Cm
Cavimend
Amendia
CavimendINFLATABLE BONE EXPANDER SYSTEM
Cm
CavimendInflatable Bone Expander System
Table of Contents
Features and Benefits 1Introduction 2Indications 2Contraindications 2Pre-Operative Setup 3Patient Positioning 3Trocar Placement 4Trocar Placement Continued 5Cement Delivery 6Contact Information 7
Surgical Technique Guide
Cavimend
Amendia
CavimendINFLATABLE BONE EXPANDER SYSTEM
CmSurgical Technique Guide
Features & Benefits• Minimally invasive Spine Surgery• Fast pain relief • Safe delivery of bone cement • User friendly approach• Fast recovery
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Unilateral Kit Contents: CMD-10-1-a, CMD-15-1-a, CMD-20-1-aCMD-BN Cavimend Osteo Introducer System 1CMD-CM Cavimend Bone Filler Device 5CMD-DR Cavimend Drill 1CMD-xxBC-a Cavimend Balloon Catheter (Specify size 10, 15, or 20mm) 1CMD-CP Cavimend Compressor 1
Bilateral Kit Contents: CMD-10-a, CMD-15-a, CMD-20-aCMD-BN Cavimend Osteo Introducer System 2CMD-CM Cavimend Bone Filler Device 6CMD-DR Cavimend Drill 1CMD-xxBC-a Cavimend Balloon Catheter (Specify size 10, 15, or 20mm) 2CMD-CP Cavimend Compressor 2
Part Number Volume (cm3)
Length (mm)
Diameter (mm)
CMD-10BC-a0 11.02 16.3 11.84 18.2 16.6
CMD-15BC-a0 16.52 17.9 12.04 20.6 16.0
CMD-20BC-a
0 212 20.5 11.94 22.4 16.16 25.9 18.2
CMD-20BC-a
0 21.02 20.5 11.94 22.4 16.16 25.9 18.2
Cavimend
Amendia
CavimendINFLATABLE BONE EXPANDER SYSTEM
CmSurgical Technique Guide
IntroductionBalloon Kyphoplasty is a minimally invasive percutaneous method for stabalizing the spine. It offers a good alternative for patients who fail to respnd to the traditional approaches of bed rest, analgesics and back braces. Cavimend helps to restore some of the height lost with fracture and reduce the angle of the deformity.
Indications
• Vertebral compression fracture • Osteoporosis • Metastic Bone Tumor
Contraindications • Infection of the fractured vertebra• Severe hemorrhagic diathesis• Known allergies to the cement• Pregnancy
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Cavimend
Amendia
CavimendINFLATABLE BONE EXPANDER SYSTEM
CmSurgical Technique Guide
Pre-Operative Setup For Bone Access• Surgical Marker Pen • Scalpel • Surgical Mallet • One step starter Cannula • One Step Starter Trocar• Drill
For Fracture Restoration • Compressor • Balloon Catheter • 20cc Syringe • Contrast liquid
Patient Positioning The prone position is recommended to reduce load on the fractured bone. If the fracture is located in the lumbar lordotic curvature, place the patient into hyper-lordosis.
Prone position with arms adducted for upper thoracic approaches. A narrow cushion allows the shoulders to drop foward.
For Bone Stabilization • Bowl • Bone Cement • Cement Bar& Infusion • 10cc Syringe
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Cavimend
Amendia
CavimendINFLATABLE BONE EXPANDER SYSTEM
CmSurgical Technique Guide
Trocar Placement Insert the one step cannula and trocar to the correct position in the pedicle by using fluoroscopy. Then, pierce the cortical bone. Then separate and remove the one step starter trocar from cannula.
Insert the Drill through the cannula to prepare a space for the Balloon Catheter. Sufficient drilling protects the balloon from damage by sharp fragments bone during inflation.
Pushing the latch to the right engages the threaded plunger shaft and allows for gradual controlled movement of the plunger
Pushing the latch tot he left release the thread of the plunger and allows simple unlocked movement
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Cavimend
Amendia
CavimendINFLATABLE BONE EXPANDER SYSTEM
CmSurgical Technique Guide
Trocar Placement Fill the cylinder of the compressor with contrast media by aspirating it through the 3-way stopcock. Remove remainig air in the cylinder or tube by turning the spindle. While doing this, hold the balloon compressor upright.
Connect the 3-way stockcock of the compressor to the Balloon Catheter. Then, remove any air in-side of the Balloon Catheter.
Insert the Balloon Catheter into the prepared vertebral body. Then, inflate the Balloon Catheter to make a cavity inside of the vertebral body by turning the compressor handle clockwise until the de-sired height or maximum pressure is attained. Refer to table B for height, volume and pressure.
Maximum balloon pressure is 400 psi. Volume is measured unconstrained at 37oC in water at 1 atm. Constraints inside the vertebral body may limit balloon expansion.
Part Number Volume (cm3) Length (mm) Diameter (mm)
CMD-10BC-a0 11.02 16.3 11.84 18.2 16.6
CMD-15BC-a0 16.52 17.9 12.04 20.6 16.0
CMD-20BC-a
0 21.02 20.5 11.94 22.4 16.16 25.9 18.2
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Cavimend
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CavimendINFLATABLE BONE EXPANDER SYSTEM
CmSurgical Technique Guide
Cement Delivery Mix the PMMA cement to the manufacturer’s specification. Then, wait for it to reach the proper vis-cosity to deliver through the cement bar.
Use syringes to fill the prepared bone cement into the Cement Infusion Cannula.
Deliver the mixed cement into the cavity using the Cement Bar. Then, remove the Cement Bar and Cement Infusion Cannula.
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CavimendINFLATABLE BONE EXPANDER SYSTEM
CmSurgical Technique GuideSurgical Technique Guide
Cavimend
This product is sterilized by EO Gas and follows CE and FDA Standard Regulations
Caution: Federal Law restricts this device to sale by or on the order of a physician
Manufactured for:
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