a new movement - pacific surgical single injection... · a new movement in oa treatment...

2
MONOVISC is a trademark of Anika Therapeutics, Inc. Anika Therapeutics, Inc., Bedford, MA 01730 U.S.A. AML 900-010 A New Movement in OA Treatment Cross-Linked Sodium Hyaluronate MONOVISC is a clinically proven advanced viscosupplement for osteoarthritis (OA) pain relief. Unique formulation Single injection Superior pain reduction High concentration of Hyaluronic Acid Discover the lifestyle-rejuvenating power. Get Patients Back on Their Feet and Keep Them There ABOUT MONOVISC Description MONOVISC is a sterile, non-pyrogenic, sodium hyaluronate solution, lightly cross-linked with a proprietary chemical cross-linker. Contains 22 mg/mL of lightly cross-linked sodium hyaluronate (NaHA) dissolved in phosphate-buffered saline at physiological osmolality Manufactured from ultra-pure, high molecular weight sodium hyaluronate produced by bacterial fermentation Application MONOVISC Cross-Linked Sodium Hyaluronate Injection is a single, intra-articular injection of cross-linked sodium hyaluronate designed to treat the symptoms of osteoarthritis. Indication MONOVISC is indicated as a viscoelastic supplement or a replacement for synovial fluid in human joints. Well suited for treatment of the symptoms of human joint dysfunctions such as osteoarthritis The actions of MONOVISC are lubrication and mechanical support Directions for use The required amount of MONOVISC is injected through a sterile, disposable hypodermic needle of suitable gauge into the selected joint space. Adverse reactions Hyaluronic acid is a natural component of the tissues of the body. MONOVISC is thoroughly tested to determine that each batch conforms to the product quality attributes. Since sodium hyaluronate molecules are non-inflammatory, any phlogistic response is considered to be caused by the invasive procedure. Mild to moderate episodes of transient swelling and discomfort have occasionally been observed following intra-articular injection of sodium hyaluronate preparations. General risks associated with the procedure of injecting substances into joints may include infections and bleeding. How supplied MONOVISC is a sterile viscoelastic preparation supplied in a disposable glass syringe delivering 4.0 mL. Each syringe contains lightly cross-linked sodium hyaluronate dissolved in phosphate- buffered saline. Storage Store at 2°C to 25°C. Refer to the Instructions for Use for complete product information. Be Part of an Exciting New Movement 10ANI001_MonoviscBrch_MECH.indd 1-3 6/6/11 2:36 PM

Upload: others

Post on 25-Dec-2019

4 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: A New Movement - Pacific Surgical Single Injection... · A New Movement in OA Treatment Cross-Linked Sodium Hyaluronate MONOVISC is a clinically proven advanced viscosupplement for

MONOVISC is a trademark of Anika Therapeutics, Inc. Anika Therapeutics, Inc., Bedford, MA 01730 U.S.A.AML 900-010

A NewMovement in OA Treatment

Cross-Linked Sodium Hyaluronate

MONOVISC is a clinically proven advanced viscosupplement for osteoarthritis (OA) pain relief.

Unique formulation Single injection Superior pain reduction High concentration of Hyaluronic Acid

Discover the lifestyle-rejuvenating power.

Get PatientsBack on Their Feet and Keep Them There

ABOUT MONOVISC Description MONOVISC is a sterile, non-pyrogenic, sodium hyaluronate solution,

lightly cross-linked with a proprietary chemical cross-linker. Contains 22 mg/mL of lightly cross-linked sodium hyaluronate (NaHA)

dissolved in phosphate-buffered saline at physiological osmolality Manufactured from ultra-pure, high molecular weight sodium

hyaluronate produced by bacterial fermentation

Application MONOVISC Cross-Linked Sodium Hyaluronate Injection is a single, intra-articular injection of cross-linked sodium hyaluronate designed to treat the symptoms of osteoarthritis.

Indication MONOVISC is indicated as a viscoelastic supplement or a replacement for synovial fluid in human joints.

Well suited for treatment of the symptoms of human joint dysfunctions such as osteoarthritis

The actions of MONOVISC are lubrication and mechanical support

Directions for use The required amount of MONOVISC is injected through a sterile, disposable hypodermic needle of suitable gauge into the selected joint space.

Adverse reactions Hyaluronic acid is a natural component of the tissues of the body. MONOVISC is thoroughly tested to determine that each batch conforms to the product quality attributes. Since sodium hyaluronate molecules are non-inflammatory, any phlogistic response is considered to be caused by the invasive procedure. Mild to moderate episodes of transient swelling and discomfort have occasionally been observed following intra-articular injection of sodium hyaluronate preparations. General risks associated with the procedure of injecting substances into joints may include infections and bleeding.

How supplied MONOVISC is a sterile viscoelastic preparation supplied in a disposable glass syringe delivering 4.0 mL. Each syringe contains lightly cross-linked sodium hyaluronate dissolved in phosphate-buffered saline.

Storage Store at 2°C to 25°C.

Refer to the Instructions for Use for complete product information.

Be Part of an Exciting New Movement

���

��

10ANI001_MonoviscBrch_MECH.indd 1-3 6/6/11 2:36 PM

Page 2: A New Movement - Pacific Surgical Single Injection... · A New Movement in OA Treatment Cross-Linked Sodium Hyaluronate MONOVISC is a clinically proven advanced viscosupplement for

The Therapeutic Benefits of Hyaluronic AcidHyaluronic Acid (HA) is vital for maintaining the function and elasticityof the synovial fluid. Delivering more HA in a single injection than any other viscosupplement, MONOVISC™ has an enormous ability to bind with water and form highly viscous polymers. As a result, it increases the ability of synovial fluid to cushion the joint and absorb shocks. It’s a proven solution for treating joint dysfunction.

Softening and Cushioning the impact on joint tissues, synovium, cartilage

and bones. Your patients can enjoy daily physical activities again with reduced pain.

High Concentrationof HA added to the synovial fluid

creates a high viscosity environment, replicating healthy joint function.

It‘s the Right Choice for Patients in All Circumstances.

Clinically Proven to Deliver Long-Lasting Relief

In a pivotal study, MONOVISC achieved significant pain reduction against another single-injection brand for six months.1

369 patients suffering from symptomatic primary osteoarthritis of the knee were followed in a multicenter, randomized, double-blind, placebo-controlled study.

The results of the study demonstrated that MONOVISC delivered significant pain reduction against a competitor for 6 months.

The study was conducted at 31 sites: US (30 sites) and Canada (1 site) over a 26-week follow-up period.

Differences in pain reduction between MONOVISC and another single-injection product were noted at 4, 12, 22 and 26 weeks.

1 Data on file. Anika Therapeutics, Inc.

Proven Performance

WeeksBaseline 4 7/8 11/12 15/16 21/22 26

0%

-10%

-20%

-30%

-40%

-50%

-60%

WOMAC Reduction from Baseline (%) – Products

Weeks

Baseline 4 7/8 11/12 15/16 21/22 26

Perc

ent R

educ

tion

MONOVISCCompetitorMONOVISCMONOVISCCompetitorCompetitor

MONOVISC has more HA thanother single-injection products.

Comparison of MONOVISC pain reduction to a leading competitor from 4 to 26 weeks post injection.

Specially Formulated for a Single-Injection Treatment

MONOVISC is lightly cross-linked using aproprietary technology. The special formulationis optimally designed for a single-injection treatment. Cross-linking can extend the residence time of the HA molecules in the joint space.

Simple and EffectiveWith one 4 mL treatment, MONOVISC delivers significantly more HA than other single-injection products. It’s ideally suited to fill the intra-articular space. The simplicity and efficacy of MONOVISC can draw patients into your practice, and improve patient compliance and satisfaction.

Safe, Non-animal SourceMONOVISC is made from ultra-pure, high molecular weight hyaluronan produced bybacterial fermentation. Clinical studies showthat MONOVISC is very safe.

of HA60 mg

of HA

88 mg

of HA40 mg

a Single-Injection Treatment

Q MONOVISC

Q COMPETITORS

of HA48 mg

10ANI001_MonoviscBrch_MECH.indd 4-6 6/6/11 2:36 PM