Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity...

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KyForm Kyphoplasty Reformation System

Transcript of Παρουσίαση του PowerPoint - شرکت طب ... · Symptoms Progressive spinal deformity...

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

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

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

OVCFs: unrecognized 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

Kyform Kyphoplasty Reformation System

Kyphoplasty - Procedure

Balloon deflation Balloon retraction Cement injection

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)

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