TendoVis™ To relieve pain and promote the function of damaged or compromised tendons and ligaments.

 

Presentation:

TendoVis™ is a sterile, clear solution of 1% sodium hyaluronate in a phosphate-buffered saline solution and contained in a ready-to-use pre-filled syringe suitable for periarticular injection into surrounding soft tissue tendons and ligaments. Sodium hyaluronate consists of a long polysaccharide chain composed of repeating disaccharide units normally found in the human body. TendoVis™ has a pH and osmolarity that is biocompatible with soft tissue. 1.2 ml of TendoVis™, sterilized by filtration, is contained in a disposable glass syringe, ready for use. The syringe is itself contained in a blister pack, packaged in a cardboard case.

 

Usage:

TendoVis™ aims to relieve pain and optimize the restoration of tendons and ligaments damaged by acute or chronic injury. TendoVis™ sodium hyaluronate increases the naturally occurring sodium hyaluronate in the soft tissues surrounding damaged tendons and ligaments and provides support, lubrication, and hydration to the affected site thus providing the ideal environment for the damaged tissue to heal. TendoVis™ has been shown to relieve pain and optimize restoration of function in the ankle after first- or second-degree sprain, to relieve chronic pain and disability in the elbow with lateral epicondylalgia, and to relieve pain in symptomatic patients with rotator cuff tendinopathy.

 

Contraindications:

Patients with known hypersensitivity to sodium hyaluronate.

 

Dosage and administration:

Periarticular injection of TendoVis™ should only be performed by health care professionals who are familiar with the technique. The contents of the syringe are sterile and should be injected using a sterile needle of a size appropriate for the injection site. The injection area should be disinfected beforehand. Discard needle and syringe after their use.

 

Ankle sprain:

1.2 ml of TendoVis™ will be injected preferably within 48 hours after the injury, and the second 1.2 ml injection will be given within 2-3 days of the first; a 27 G needle is recommended. Periarticular injections should be performed through a single needle insertion site along the talo-fibular ligament using anatomic landmarks. The injection will be performed following 3 planes: from the antero-posterior, median, and lateral to the proximal ligament.

 

Lateral epicondylitis:

an injection of 1.2 ml of TendoVis™ into the lateral epicondyle area of the elbow, followed by an injection one week after the first; a 27 G needle is recommended. Identify the softest point of the epicondyle by performing gentle palpation. Place the needle at 45 degrees at the point of maximum pain in the lateral epicondyle. After inserting the needle into the skin, place it parallel to the skin and insert it at the point of maximum pain in the lateral epicondyle. Inject half of the contents while retracting the needle, but without pulling it out of the injection site. Rotate the needle 180 degrees (opposite direction) and insert the needle parallel to the skin toward the point of maximum pain in the lateral epicondyle. Inject the remaining contents while retracting the needle outward. Remove the needle from the insertion point on the skin. Flex and extend the elbow five times and then rotate it internally and externally five times.

 

Rotator cuff tendinopathy:

an injection of 1.2 ml of TendoVis™ into the subacromial space of the shoulder just above the tendon, followed by a second injection after 14 days; a 22 G needle is recommended. Sit the patient upright, arm outstretched and externally rotated.
The use of an ultrasound probe placed on the lateral side of the shoulder directed in the plane of the supraspinatus tendon is recommended to guide the injection. Identify the acromion, greater tubercle, head of humerus, and subacromial fissures. Introduce the needle into the fissure 1 cm distal posterior and 2 cm to the lateral antereo-acromial border. Advance the needle horizontally and in a medial direction partly under the acromion process.When no plunger resistance is felt inject TendoVis™ over the head of the humerus into the subacromial space being careful not to inject into the tendon.

 

Warnings and precautions:

TendoVis™ should only be administered by health care professionals who are familiar with the procedure. The prefilled syringes of TendoVis™ are of the disposable type. The contents of the syringe should be used for one injection.
Any residual sodium hyaluronate should be discarded. If you save the syringe for a later injection there is a risk of contamination with the possibility of patient infection and/or an external body reaction.
TendoVis™ should not be re-sterilized, as the characteristics of the device may be compromised; this could result in serious damage to the health and safety of the patient. TendoVis™ should never be injected into blood vessels because sodium hyaluronate could occlude the vessels and cause an embolus or infarction. TendoVis™ should not be injected into a hematoma. Direct injection into ligaments and tendons should be avoided, as this can lead to their potential rupture. Use of an ultrasound probe to guide the injection can minimize this risk. Do not administer into soft tissue if the injection area is inflamed, infected, and if there is evidence of either acute or chronic dermatologic disease. Sodium hyaluronate is produced by a fermentation process of Streptococcus equi and is then rigorously purified. However, health care personnel should always consider the potential risks associated with injecting biological products in general. There is a risk of infection in the area of administration as can occur generally with any periarticular procedure. There is no evidence of the safety of TendoVis™ in pregnant or lactating women. The safety and efficacy of TendoVis™ have not been tested in individuals younger than 18 years of age. Follow national or local guidelines for safe use and disposal of needles. Promptly seek medical treatment in case of injury. Do not use the product if the packaging is damaged. Do not use beyond the expiration date.

 

Side effects:

Possible mild erythema that should resolve with time.

 

Incompatibility:

TendoVis™ has not been tested for its compatibility with other substances administered by periarticular injection. Therefore, combination or simultaneous administration with other periarticular injectables is not recommended.

 

Conservation:

– Store between 2°C and 25°C.
– Do not freeze.
– Protect from light.
– Do not use if sterile package damaged.

Infiltrative techniques available on YouTube, through dedicated channels:
https://www.youtube.com/channel/UC8OmWhag0X754mbSh0rtn0w