Tissumend II Sterile

Manufacturer: V.P.L.

Synthetic Absorbable Tissue Adhesive

Description And Function

TISSUMEND II STERILE Synthetic Absorbable Tissue Adhesive is a patented, unique absorbable composition consisting of a methoxypropyl cyanoacrylate monomer, polymeric modifiers and sterilized by gamma radiation, a process to allow its use in most surgical procedures.

Tissumend Ii Sterile Has The Following Advantages Over Current Cyanoacrylate Adhesives

Can be used for both internal and external tissue closure. Is absorbed via hydrolysis. Has reduced exothermic properties upon polymerizing resulting in reduced cytotoxicity and enhanced tissue acceptance. Forms an exceptional adhesive joint that is favorably compliant with tissue. Is delivered in a surgeon-friendly package.

TISSUMEND II STERILE polymerizes forming a strong bond between most tissue surfaces within 10 seconds after application. TISSUMEND II STERILE provides the surgeon hemostatic properties in combination with superior adhesive qualities.

Tissumend II Sterile Indications

TISSUMEND II STERILE is indicated for the closure of surgical wounds, internal tissue closure, incision sites, hemostasis and laser surgical procedures. TISSUMEND II STERILE can also be used for declaws, tail dockings, and debrided traumatic wounds.

Contraindications

TISSUMEND II STERILE is contraindicated in the management of infected wounds or situations where tissue closure would be detrimental to the patient. This product is not intended for intravenous administration.

Tissumend II Sterile Caution

To be used by or under the supervision of a licensed veterinarian.

Not For Human Use

Precautions/warnings

Avoid contact with clothing since the adhesive may be permanent. Avoid contact with metal instruments. If adhesive accidentally gets in the eye, the eyelids should be kept open and the eye surface thoroughly washed with water.

Accidental Application

TISSUMEND II STERILE may be removed from surfaces with chloroform, dimethylsulfoxide or acetone. These removal agents should not be used in situations that may cause injury or harm to the patient.

Storage

Package should be stored under refrigeration 35 - 40°F. After pouch has been opened, sterilization aid should be discarded. Unused TISSUMEND II STERILE should be discarded. Avoid prolonged exposure of TISSUMEND II STERILE to temperatures above 32°C (90°F). The product should not be used beyond the indicated expiration date.

Recommended Surgical Use

1. Site Preparation: The surgical site should be prepared in an appropriate manner. The surgical site should be dried as much as possible before application to ensure fluids do not interfere with polymerization of TISSUMEND II STERILE.

2. After the pipette has reached room temperature, the pipette should be cut off near the distal end of the tube.

Do Not Over-apply Tissumend Ii Sterile. a Light Thin Coat Is Better Than A Thick, Heavy Coat. Over-application May Result In Unpredictable Healing.

clinical Trials*

Studies have been conducted using TISSUMEND II STERILE on renal, lung and cornea tissues.

Repair of Renal Lacerations / Injuries Using Sterile Absorbable Tissue Adhesive in Rabbits

The adhesive formed a rapid seal on renal incisions and provided immediate hemostasis upon application. The time required to attain a repair of similar incisions was much quicker using adhesive over suturing and the incidence of suture "pull through" was eliminated. There was no incidence of adhesions to the adhesive repaired incision while 50% of the suture repaired incisions demonstrated notable adhesions. Histologically, the incision sites for the absorbable suture and tissue adhesive showed similar collagen depositions indicating that the wound repair process was comparable. The absence of post-operative adhesions, which are associated with braided suture, makes the adhesive a more desirable choice for internal soft tissue repair.

Comparative Efficacy Of Two Surgical Closure Methods For Lung Lacerations In Dogs And Cats

The tissue adhesive worked well on distal lung lobe lacerations when a minimal amount of adhesive was used to seal the tissue. The tissue adhesive did not tend to tear feline lung tissue compared with suture. It was recommended to control hemorrhage and place tension parallel to the laceration during application of the adhesive. Apposition of laceration edges was not necessary to accomplish a seal. Lungs should not be overinflated or stretched perpendicular to the laceration after adhesive application. The adhesive can be applied over suture lines of tissues under tension, such as tracheal anastomoses, to help prevent postoperative leakage and subcutaneous emphysema.

Repair Of Corneal Defects Using Sterile Absorbable Tissue Adhesive In Rabbits

Histological examination of the cornea following superficial keratectomy and application of the adhesive showed the regeneration of normal corneal tissues. The adhesive appeared to aid in the normal healing process. Application of the adhesive to the intact cornea was histologically benign. Use of the adhesive appeared to aid in the restoration of damaged corneal tissue without adverse histological effects.

Note

During the sterilization process, there may be a rare instance of the polymer crystallizing in the pipette. If you notice this occurrence, do not use the pipette and please call 1-888-241-9545 for replacement.

How Supplied

Product code: 3005239, TISSUMEND II STERILE Synthetic Absorbable Tissue Adhesive is supplied in individual prefilled pipettes (0.2mL). Each box contains 6 individual nitrogen flooded pouches containing 1 pipette and one sterilization aid each.

* References available upon request

Veterinary Products Laboratories, Phoenix, Az 85013

For information, please call 1-888-241-9545.

©2005 Veterinary Products Laboratories

RM #: 2006288

04-2008

Nac No.

11430770