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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

May 22, 2018

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Page 1: 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

Page 2: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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

Page 5: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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

Page 7: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

Latin America: 46%, North America: 45% Europe: 29% S. Africa: 29% Australia: 29%

OVCFs: unrecognized Kyform Kyphoplasty Reformation System

Page 10: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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

Page 13: 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

Kyphoplasty - Procedure

Balloon deflation Balloon retraction Cement injection

Page 15: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

Before

After

Kyphoplasty - Procedure Kyform Kyphoplasty Reformation System

Page 16: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

More precise bone height restoration

Effective reduction of spine deformity

Less cement leakage / lower complication risk

Kyphoplasty: advantages Kyform Kyphoplasty Reformation System

Page 17: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

New Product: “Kyform”

Kyphoplasty Reformation Balloon Kit

CE marked

Page 18: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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

Page 19: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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

Page 20: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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

Page 21: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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

Page 22: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

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

Page 23: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

FEATURE BENEFIT

Ergonomic handle design Stability & Controlled expansion

Lock Mechanism Easy pressuring locking and 1-step release

Kyform Inflator Kyform Kyphoplasty Reformation System

Page 24: Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity (Kyphosis) Severe back pain Loss of bone mass Loss of height Immobility Spinal

• 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