Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

KyForm Kyphoplasty Reformation System

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

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Symptoms

Progressive spinal

deformity (Kyphosis)

Severe back pain

Loss of bone mass

Loss of height

Immobility

Spinal Vertebra Fracture Kyform Kyphoplasty Reformation System

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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

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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

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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

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Vertebroplasty

Introduction of a needle into the collapsed

vertebra under x-ray guidance

Injection of the vertebral body with liquid

bone cement


Originally developed in France (1986) U.S.A. (1991)

Minimally invasive, non-surgical

procedure

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Newer procedure, modification of the vertebroplasty approach

Usage of balloons prior to bone cement injection

Kyphoplasty Kyform Kyphoplasty Reformation System

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Incision Cannula insert Drilling the access channel Balloon guidance Balloon inflation restoration +

elevation

Kyphoplasty - Procedure Kyform Kyphoplasty Reformation System

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Kyphoplasty - Procedure

Balloon deflation Balloon retraction Cement injection

Bilateral approach

Bi-lateral approach: 2 balloons simultaneously


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Before

After

Kyphoplasty - Procedure 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

New Product: “Kyform”

Kyphoplasty Reformation Balloon Kit

CE marked

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)


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


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


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

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Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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