VISCO-3™ Sodium Hyaluronate

A double-blind, multi-center, randomized, controlled trial was conducted in which VISCO-3 Sodium Hyaluronate*was compared to Euflexxa^® 1% Sodium Hyaluronate (NCT 02110238). The study enrolled a total of 421 subjects.¹

Safety ²

Safety analysis included all subjects who received at least one injection (n = 211 Euflexxa, n = 209 VISCO-3). There was no significant difference in the total Treatment-Emergent Adverse Events (TEAEs) with VISCO-3 Sodium Hyaluronate compared to Euflexxa (Table 1). A total of seven serious adverse events (SAE) were reported, however none were considered to be related to the study devices. There were no reports of pseudoseptic events or allergic reactions in the study. The most common device related adverse events in the VISCO-3 group were arthralgia (1%), joint swelling (1.4%) and injection site pain (1%). 

Table 1: Overall Summary of Treatment-Emergent Adverse Events (TEAEs)

Effectiveness²

The analysis of effectiveness was based on the 384 evaluable patients over the 12 week time point. The effectiveness of the treatments was measured as WOMAC VAS pain subscale change from base line (CFB). The Key effectiveness outcomes are presented below (Table 2). The mean baseline WOMAC VAS pain subscale was 57.83 in the VISCO-3 Sodium Hyaluronate group and 58.40 in the Euflexxa Sodium Hyaluronate group. The least squares mean for CFB for VISCO-3 Sodium Hyaluronate minus that of the control gives a WOMAC VAS subcale sore of -3.30 mm.

Table 2: Effectiveness Analysis; CFB of WOMAC VAS Pain Subscale Through Study Duration

VISCO-3 Sodium Hyaluronate demonstrated noninferior pain relief compared to patients treated with Euflexxa Sodium Hylauronate. This is concluded based upon the fact that the lower bound of the 95% CI (-6.77 mm) is greater than -8 mm. On average, patients treated with VISCO-3 Sodium Hyaluronate saw a 52% reduction in pain at week 12 compared to baseline.

Post Market Experience²

Literature has shown that repeated treatment cycles of the VISCO-3 Sodium Hyaluronate formulation contain no evidence of an increased safety risk. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. 

VISCO-3^™ is a sterile, viscoelastic non-pyrogenic solution of purified, high molecular weight (620,000-1,170,000 daltons) sodium hyaluronate (hyaluronan) having a pH of 6.8-7.8. Each one mL of VISCO-3 solution contains 10 mg of sodium hyaluronate (hyaluronan) dissolved in a physiological saline (1.0% solution). The sodium hyaluronate (hyaluronan) is extracted from chicken combs. Sodum hyaluronate (hyaluronan) is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine.

Each 2.5 mL prefilled syringe of VISCO-3 solution contains:

Sodium Hyaluronate (hyaluronan) 25.0 mg

Sodium Chloride 21.25 mg

Dibasic Sodium Phosphate Dodecahydrate 1.343 mg

Sodium Dihydrogen Phosphate Dihydrate 0.04 mg

Water for Injection q.s.

Strict aseptic administration technique must be followed. Apply antiseptic to the skin and, if desired, local subcutaneous anesthetic such as lidocaine may be injected prior to injection with VISCO-3 Sodium Hyaluronate. Do not use disinfectants containing quaternary ammonium salts for skin preparation.

The knee joint may be accessed through the soft palpable anterolateral port, located just lateral to the inferior pole of the patella and the proximal portion of the patella tendon (Figure 1) or other approach per physician preference.

If present, remove joint effusion before injecting VISCO-3 Sodium Hyaluronate (Figure 2).

Peel off the lid from the VISCO-3 Sodium Hyaluronate blister package and remove the syringe. Carefully remove the tip cap of the VISCO-3 Sodium Hyaluronate syringe. Aseptically attach the VISCO-3 Sodium Hyaluronate syringe to a sterile 22-23 gauge needle.

Inject the full 2.5 mL of VISCO-3 Sodium Hyaluronate into the knee joint using aseptic injection technique (Figures 3-4). If administering treatment to both knees, use a separate syringe of VISCO-3 Sodium Hyaluronate for each knee.

Administer the subsequent two intra-articular injections one week apart, for a total of three injections 1 week apart for 3 weeks.

VISCO-3 Sodium Hyaluronate is supplied as a sterile, non-pyrogenic solution in 2.5 mL prefilled syringe (1.0% solution[ 10 mg/mL] 25mg total sodium hyaluronate (hyaluronan). VISCO-3 Sodium Hyaluronate is administered by intra-articular injection once a week (1 week apart) for a total of 3 injections. 

Store in the original packaging below 77°F (25°C). DO NOT FREEZE.

DO NOT USE after expiration date indicated on package. VISCO-3 Sodium Hyaluronate has a shelf life of 42 months.

The prefilled syringe is intended for single use.

• Use immediately once the container has been opened.
• Discard any unused VISCO-3 Sodium Hyaluronate

DO NOT USE if the package is opened or damaged.

Questions regarding reimbursement may be addressed by contacting the Zimmer Biomet Reimbursement Hotline:

Phone: 1-866-946-0444

Email: reimbursement@zimmer.com

Zimmer Biomet Reimbursement Hotline Hours: Monday-Friday, 8am-5pm EST

Information and material about reimbursement is informational only.  Changes in reimbursement laws, regulations, and policies may occur without notice.  Providers should report  the procedure and related codes that most accurately describe the particular patient’s medical condition, procedures performed, and products used based on the provider’s experience and Medicare rules and guidelines and other payer requirements.  Zimmer Biomet specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information and material about reimbursement.

Ordering VISCO-3 Sodium Hyaluronate is easy and convenient. The product may be ordered through your Zimmer Biomet sales representative, by phone or fax.

Orders must be placed before 2:30pm Eastern time to ensure same day shipping

Orders will not ship on Fridays

Product #: 00-1111-001-03

Telephone: 1-800-348-2759

Fax: 574-372-4319

Zimmer Biomet Customer Service Hours: Monday – Friday, 8 am – 6 pm EST.