Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity...
Transcript of Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity...
Spinal Vertebra Fracture
Spinal Fracture or Vertebral Compression Fracture (VCF): collapse of a vertebra due to trauma / weakening of the vertebra
Kyform Kyphoplasty Reformation System
Causes
Osteoporosis
Cancer
Tumors (primary or metastatic)
Trauma
Spinal Vertebra Fracture Kyform Kyphoplasty Reformation System
Symptoms
Progressive spinal
deformity (Kyphosis)
Severe back pain
Loss of bone mass
Loss of height
Immobility
Spinal Vertebra Fracture Kyform Kyphoplasty Reformation System
8.9 million+ fractures annually
worldwide 75 million+ people in the U.S.A., Europe
& Japan
Osteoporotic Vertebral Compression
Fracture (OVCF): 1.400.000 cases / year
Osteoporosis statistics Kyform Kyphoplasty Reformation System
1 in 3 women over 50 and 1 in 5 men are at risk of an osteoporotic fracture
“Silent” disease
Osteoporosis statistics Kyform Kyphoplasty Reformation System
Latin America: 46%, North America: 45% Europe: 29% S. Africa: 29% Australia: 29%
OVCFs: unrecognized Kyform Kyphoplasty Reformation System
Non-surgical Treatments
Before the 1980s…
Medication (analgesics & anti-inflammatory drugs)
Bed rest
Physiotherapy
Back bracing
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Vertebroplasty
Kyphoplasty
Fusion (usage of screws)
Invasive Procedures Kyform Kyphoplasty Reformation System
Vertebroplasty
Introduction of a needle into the collapsed
vertebra under x-ray guidance
Injection of the vertebral body with liquid
bone cement
Kyform Kyphoplasty Reformation System
Originally developed in France (1986) U.S.A. (1991)
Minimally invasive, non-surgical
procedure
Newer procedure, modification of the vertebroplasty approach
Usage of balloons prior to bone cement injection
Kyphoplasty Kyform Kyphoplasty Reformation System
Incision Cannula insert Drilling the access channel Balloon guidance Balloon inflation restoration +
elevation
Kyphoplasty - Procedure Kyform Kyphoplasty Reformation System
Kyform Kyphoplasty Reformation System
Kyphoplasty - Procedure
Balloon deflation Balloon retraction Cement injection
Bilateral approach
Bi-lateral approach: 2 balloons simultaneously
Kyform Kyphoplasty Reformation System
More precise bone height restoration
Effective reduction of spine deformity
Less cement leakage / lower complication risk
Kyphoplasty: advantages Kyform Kyphoplasty Reformation System
Indicated for the minimal invasive surgery of VCFs, consists of the following:
2 x Balloon catheter 2 x Balloon expander (inflator)
2 x Bone marrow needle 2 x Guidewire
2 x Access Cannula 1 x Bone drill 6 x Bone cement filler
.
Components Kyform Kyphoplasty Reformation System
CE marked (DEKRA, Germany)
Individually packaged components
EtO sterilized
Single use
36 months of shelf life
3 sizes (10, 15 & 20mm)
Kyform Kyphoplasty Reformation System
Balloon catheter
3 balloon sizes (length: 10 mm, 15mm, 20 mm)
Highly-compliant balloon with Platinum marker band
2-lumen TPU shaft
Hub with molded kinking protection
Vacuum valve
Kyform Kyphoplasty Reformation System
FEATURE BENEFIT
Integrated stylet No risk of damaging balloon
Platinum marker band
Proper balloon advancement / placement
No sharp tip at distal end of catheter No risk of damaging the back wall of the
vertebra
Distal end forms symmetrically
(round finishing)
Cavity created where balloon is placed
Balloon Catheter
FEATURE BENEFIT
Stainless steel bevel tip (bone marrow
needle)
Accurate channel creation prior to balloon
insertion
Low profile trocar tip (bone drill) Facilitate cortical penetration
Front-opening tip (bone cement filler) Targeted cement placement in the
vertebral body
Access Cannula/Bone drill
Kyform Kyphoplasty Reformation System
FEATURE BENEFIT
Ergonomic handle design Stability & Controlled expansion
Lock Mechanism Easy pressuring locking and 1-step release
Kyform Inflator Kyform Kyphoplasty Reformation System
• Prompt pain relief / safe & effective
• 1-day procedure
• Comeback to normal daily activity
• Decreased need for medication
• Quality of life
Benefits Kyform Kyphoplasty Reformation System