ophthalmic viscosurgical devices (ovds) - rumex...

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Rumex International Co. Rumex International LTD. Ophthalmic Viscosurgical Devices (OVDs) Head office: RUMEX INTERNATIONAL COMPANY 13770 58th Street North, Suite 317 Clearwater, FL 33760, USA Manufactured: RUMEX INTERNATIONAL Limited 311 Shoreham street Sheefield, South Yorkshire, S2 4fa UK

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Page 1: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

Rumex International Co.

Rumex International LTD.

Ophthalmic Viscosurgical

Devices (OVDs)

Head office:

RUMEX INTERNATIONAL COMPANY 13770 58th Street North, Suite 317

Clearwater, FL 33760, USA

Manufactured: RUMEX INTERNATIONAL Limited 311 Shoreham street Sheefield,

South Yorkshire, S2 4fa UK

Page 2: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

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Rumex OVDs

CE Marked November 2011

1.0 ml

Page 3: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

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SmartVisc, SmartVisc+

Are viscoelastics based on sodium hyaluronate from biotechnical

fermentation and are free of pyrogenic substances.

SmartVisc 1.6% Sodium hyaluronate

SmartVisc+ 3.0% Sodium hyaluronate

Page 4: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

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SmartVisc, SmartVisc+

Will help you maintain the important working space!

• Ability to deepen the anterior and posterior chambers to allow for easier capsulorhexis

and lens implantation

• Excellent tissue manipulation

• Completely transparent to enhance visualisation during cataract and vitreoretinal surgery

• Asrpiration is quick and easy. Additionally, there is less chance for trapped viscoelastic

behind the optic.

Page 5: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

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PREREQUISITES FOR VISCOELASTICS DURING

PHACOEMULSIFICATION:

SURGICAL STEPS

PRIMARY FUNCTION

PROPERTIES REQ’D

CATEGORY

Entry into AC Easy entrance for cannula

Medium viscosity @ high shear rate

SmartVisc

Capsulorrhexis Maintain AC High viscosity @ low shear rate

SmartVisc+

Open Capsular Bag Maintain AC & capsular

High viscosity @ low shear rate

SmartVisc+

IOL Implant No resistance Medium viscosity @ medium shear rate

SmartVisc

VES Removal Complete & rapid elimination

High MW & large molecule

SmartVisc SmartVisc+

Page 6: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

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SmartVisc 1.6%

Technical data: Sodium Hyaluronate: 1.6 %

Molecular Weight: 1.2 - 2.0 million Daltons

Viscosity: aprox 80.000 mPs

Osmolarity: 270 - 400 mOsm/kg Storage: 2 – 25°C

pH: 6.8 - 7.4

Volume: 1 ml

Shelf life 3 years

Cannula 27 gauge

Soft coating and

protection of endothelial

cells

High cohesion for

easy irrigation / aspiration

Formula:

1 ml contains

Sodium hyaluronate 16.000mg Sodium chloride 8.500 mg Disodium hydrogenphosphate 0.563 mg Sodium dihydrogenphosphate 0.045 mg Water for injection q.s.

Page 7: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

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SmartVisc + 3.0%

Technical data: Sodium Hyaluronate: 3.0 %

Molecular Weight: average 1.0 - 1.8 million

Viscosity: aprox 400.000 mPs

Osmolarity: 270 – 400 mOsm/kg

Storage: 2 – 25°C

pH: 6.8 - 7.4

Volume: 1 ml

Shelf life 3 years

Cannula 27 gauge

High Viscosity

Soft coating and

protection of endothelial

cells

High cohesion for

easy irrigation / aspiration

Formula:

1 ml contains

Sodium hyaluronate 30.000mg Sodium chloride 8.500 mg Disodium hydrogenphosphate 0.563 mg Sodium dihydrogenphosphate 0.045 mg Water for injection q.s.

Page 8: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

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Features

• Two different viscosities (80&400) can provide Viscoelastic Soft Shell Technique

• Low molecular weight - easy to remove after surgery

• Ultrapure Hyaluronic Acid with highest biocompatibility

• Clear view of posterior capsule during phacoemulsification

• No refrigeration necessary – storage 2-25°

• Volume: 1 ml

Page 9: Ophthalmic Viscosurgical Devices (OVDs) - Rumex Internationalrumex.com/download/Ophthalmic_Viscosurgical_Devices_SmartVisc... · Ophthalmic Viscosurgical Devices (OVDs) ... Capsulorrhexis

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Competitors in the global market

Brand Producer Volume of

Syringe

MW (D) Composition Storage Cohesive Dispersive

Provisc Alcon Labs, USA 0.4;0.55;0.85 2 500 000 1 % NaHa 2-8°C + -

Viscoat Alcon Labs,

USA

0.5 600 000 3 % NaHa,

4 % CDS

2-8°C - +

DisCovisc Alcon Labs,

USA

0.5;1.0 1 650 000 1.7 % NaHa,

4 % CDS

2-8°C + +

Healon AMO, USA 0.4;0.55;0.85 4 000 000 1 % NaHa 2-8°C + -

Healon GV AMO, USA 0.55;0.85 5 000 000 1.4 % NaHa 2-8°C + -

Healon 5 AMO, USA 0.6 4 000 000 2.3% NaHa 2-8°C + +

Amvisc Bausch&Lomb, Inc.,

USA

0.8 2 000 000 1.2 % NaHa 2-8°C + -

Amvisc Plus Bausch&Lomb, Inc.,

USA

0.8 1 500 000 1.6 % NaHa 2-8°C + -

Multivisc BVI, USA 0.6 7 900 000 2.5% NaHa 2-8°C + +

OVD1.2% BVI, USA 1.0 3 000 000 1.2 % NaHa 2-8°C + -

SmartVisc Rumex Int. Ltd, UK 1.0 1 200 000-

2 000 000

1.6% NaHa 2-25 °C + -

SmartVisc+ Rumex Int. Ltd, UK 1.0 1 000 000-

1 800 000

3.0 % NaHa 2-25 °C + -

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Rumex OVDs ‘SUPREME’

CE Marked November 2011

Supreme is a viscoelastic solution of high molecular weight, highly purified grade of hydroxypropyl

methylcellulose 2%, clear, isotonic, sterile, non inflammatory and non-pyrogenic in nature. It is used for

intraocular injection during anterior segment surgery of the eye.

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Product Features

Supreme is a medical device used in the anterior segment surgery of the eye. It has the following unique

characteristics:

•It maintains the depth of the AC of the eye

•It protects the periocular tissues

•Outstanding rheological properties

•Completely transparent

•Simple to remove from the AC

•Totally non antigenic

•Does not contain any proteins likely to cause inflammotary reactions or foreign body reactions

•Does not require refrigeration

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Properties

Molecular Weight 86,000 daltons

Dynamic Viscosity 3000 – 4500 cPs at 27⁰C

pH 6.0 – 7.8

Osmolality 250-350 mosmol/Kg

Volume 2 ml pre-filled glass syringes in double pouch

packing

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Competitors in the global market

Brand Producer Volume of Syringe (ml)

Composition Viscosity (mPas)

MW (D)

Cellugel Alcon Labs., USA)

1.0 2% НРМС 30 000±10 000 300 000

Ocucoat Bausch & Lomb, USA

2.0 2% НРМС 4000 ±1500 92 000

Appavisc Appasamy, India

3.0 2% НРМС 2000 7000

Metilon20 BioTech, India 2.0 2% НРМС 4200 86000

Metilon24 BioTech, India 2.0 2.4% НРМС 4200 86000

Supreme Rumex Inc. Ltd, UK

2.0 2% НРМС 3000-4500 86000

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Head office:

RUMEX INTERNATIONAL COMPANY 13770 58th Street North, Suite 317

Clearwater, FL 33760, USA Tel: +1 (727) 568 0909

Toll Free: +1 (877) 77 RUMEX Fax: +1 (727) 568 0919

Email: [email protected] Webstore: www.rumex.net

Skype: rumex.net

Manufactured: RUMEX INTERNATIONAL Limited 311 Shoreham street Sheefield,

South Yorkshire, S2 4fa UK Tel: +371 6616 3182

Thank you!