Bone Cement for Vertebroplasty & Kyphoplasty

PHYSICO-CHEMICAL COMPOSITION PMMA bone cement made of polymer powder containing HA particles and liquid monome.r

BIOCOMPATIBLE5% hydroxylapatite particles in Opacity+® provides a biocompatible surface. EASY INJECTIONThe initial low viscosity makes easier the mixing and filling of the injection system

The Opacity+® is injectable through a small gauge needle.

PHYSICO-CHEMICAL COMPOSITION PMMA bone cement made of polymer powder containing HA particles and liquid monome.r

BIOCOMPATIBLE5% hydroxylapatite particles in Opacity+® provides a biocompatible surface. EASY INJECTIONThe initial low viscosity makes easier the mixing and filling of the injection system

The Opacity+® is injectable through a small gauge needle.

Proper t ies

Specificat ion of use

Ind icat ions

The OPACITY+® is indicated for the fixation of

pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

The viscosity of Opacity+®, specifically design for vertebroplasty offers out outstanding advantages:

The well adapted rheology allows optimal injection time giving peace of mind to the clinician.

When following the recommended application phase, the implantation of Opacity+® within its pasty phase will offer :

• A good penetration into spongious tissues without leakage

• An optimal distribution of the volume of cement into the vertebra.

The OPACITY+® is indicated for the fixation of

pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

The viscosity of Opacity+®, specifically design for vertebroplasty offers out outstanding advantages:

The well adapted rheology allows optimal injection time giving peace of mind to the clinician.

When following the recommended application phase, the implantation of Opacity+® within its pasty phase will offer :

• A good penetration into spongious tissues without leakage

• An optimal distribution of the volume of cement into the vertebra.

OPACITY+® is a self-curing and ready to use low viscosity bone cement with a very high content of radiopaque agent for a perfect and safety visualizationIts composition has been optimized to get the most suitable handling properties for vertebroplasty & kyphoplasty.

INJECTION TIME 13MN

SYNTHETIC

HIGH RADIO-OPACITY

VISCOSITY

The Opacity+® is low viscosity, providing more homogenous bone filling with minimizing leakage potential.

RADIO OPACITYOpacity+® has an increased radiopacity agent (50%) for maximum visibility and control. Better contrast allows improved continuous real time view of the flow of cement, reducing risk of leakage. Can be used either under fluoroscopy or CT scan.

VISCOSITY

The Opacity+® is low viscosity, providing more homogenous bone filling with minimizing leakage potential.

RADIO OPACITYOpacity+® has an increased radiopacity agent (50%) for maximum visibility and control. Better contrast allows improved continuous real time view of the flow of cement, reducing risk of leakage. Can be used either under fluoroscopy or CT scan.

LOW VISCOSITY

EASY & SAFE INJECTION

Technica l data & c l in ica l cases :

SPINE

0 5 10 15 20 25 30

1000

100

10

1

Visc

osity

(Pa.

s)

Time (min.)

OSTEOPOROTIC FRACTURE AFTER VERTEBROPLASTY

The high radio-opacity offers a confortable visual control during cement application.

The viscosity of Opacity+® allows a simple filling

of bone and is recommended in all cases.

0 5 10 15 20 25 30

18

20

23

Time (min)

Tem

pera

ture

(°C)

Influence Of Temperature On HandlingTimes :: +/- 1 min

Mixing Filling and waiting Injection* hardening**

Storage

Products

T040320ZOpacity+®

DESIGNATION REFERENCE

The cement is to be stored in its original, unopened packaging, in a dry, clean place, away from light and at a temperature of 25°C max.

Each dose of Opacity+® contains two sterile components. A pouch of powder and a ampoule of liquid monomer.Single use only. For any further information, please refer to the IFU.

ADDITIONAL ITEMS APART

T060410 T060409T060406Contact us

S5 KIT EASY KITMINI-MALAX Mixing & injection systemTEKNIMED NEEDLES

Cré

dits

pho

tos

: ©

Tek

nim

ed -

TF4

3104

Z/In

d 6

- 10

2/20

20

Radiopaque Bone Cement

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Manufactured by

Head offices:8, rue du Corps Franc-Pommiès 65500 VIC en BIGORRE (France)Tél (33) 5 62 96 88 38Fax (33) 5 62 96 28 72

Administration and supply-chain offices:Z.I de la Herray65500 VIC en BIGORRE (France)Tél (33) 5 62 96 88 38Fax (33) 5 62 96 28 72

Sales and engineering departments:Z.I. de Montredon - 12, rue Apollo31240 L'UNION (France)Tél (33) 5 34 25 10 60 Fax (33) 5 34 25 27 39

Classe IIB