COLLAPAT® II / COLLAPAT® DENTAL are bone void fillers presented in a sponge form. It is composed of a collagen structure in which ceramised hydroxyapatite granules are dispersed. The granules of hydroxyapatite give the material its osteoconductive properties. The hydroxyapatite is slowly resorbed.
As a collagen medical device, COLLAPAT® II / COLLAPAT® DENTAL have a strong haemostatic power and is completely resorbable in a few weeks. The collagen type I is extracted from bovine dermis. The manufacturing procedure comprises stages recognized to inactivate viruses and non-conventional transmissible agents such as Prions.
These treatments make it possible to ensure maximum microbiological safety for COLLAPAT® II / COLLAPAT® DENTAL as bone void fillers or bone substitutes, in particular in respect to the agent responsible for BSE.
Properties
- COLLAPAT® II / COLLAPAT® DENTAL bone void fillers are osteoconductive. It is generally completely colonised by the healthy orthotopic tissue thanks to intensive bone regeneration.
- COLLAPAT® II / COLLAPAT® DENTAL bone void fillers exert a haemostatic effect on the bone surfaces that it covers and on the muscles that are partially freed and replaced during surgery, stopping bleeding in a few minutes.
- COLLAPAT® II / COLLAPAT® DENTAL bone void fillers are ready to use and easy to handle, to mold and to trim.
- COLLAPAT® II / COLLAPAT® DENTAL bone void filler are hydrophilic: the matrix takes the consistency of a paste in contact with blood or tissue fluids.
- COLLAPAT® II / COLLAPAT® DENTAL bone void fillers perfectly fit to the anatomic area.
Indications
COLLAPAT® II / COLLAPAT® DENTAL as a bone substitutes are used to fill various types of bone lesions:
In orthopaedics, COLLAPAT® II is indicated for:
- Bone fusion during spinal fusion, arthrodesis and osteosynthesis procedures.
- Bone reconstruction during arthroplasty and revision procedures.
- Bone filling during bone defect management procedures.
In dentistry and maxillofacial surgery, COLLAPAT® II and COLLAPAT® DENTAL are indicated for:
- Bone reconstruction and filling in alveolar ridge treatment.
- Bone defect filling or sinus lift for prosthetic implantation.
- Bone filling after dental avulsion.
Examples of Usage
Specific use cases are referred in our clinical data.
Spinal surgery
• In cervical surgery: alone inside cervical fusion cage.
• In lumbar surgery: mixed with autograft and in contact with osteosynthesis material.
Foot surgery
in the treatment of Hallux valgus: to fill the defect created by the osteotomy, then to fill the defect after the removal of the screws.
Knee and Hip
in total prosthesis, between the sharpened bone and the prosthesis.
Knee in ligamentoplasty
to fill the bone graft harvesting sites and the entry to the tibial tunnel.
Method of Administration
COLLAPAT® II / COLLAPAT® DENTAL bone void fillers must be used in perfectly sterile operating conditions after adequate preparation of the site to be treated.
COLLAPAT® II / COLLAPAT® DENTAL bone void fillers can be cut, using surgical scissors, to the desired dimensions to facilitate its application. After being wet with tissue fluids, antibiotics or saline solution, COLLAPAT® II / COLLAPAT® DENTAL bone void fillers become soft and paste-like, making it easy to use to fill the cavity requiring treatment.
Draining is strongly recommended but the drains must not be in direct contact with COLLAPAT® II / COLLAPAT® DENTAL.
Rinsing of the implanted area is to be avoided.
COLLAPAT® II / COLLAPAT® DENTAL bone void fillers are not designed to be removed except in the case of post-surgical infection.
In the case of widespread and very deep bone lesions or segment defects of more than 1 to 2 cm, autologous bone shavings or PRP (Platelet Rich Plasma) should be combined with COLLAPAT® II / COLLAPAT® DENTAL bone void fillers.
Bone instabilities require supporting osteosynthesis.
Presentation and Size
| SHAPE | Width (cm) | Length (cm) | Length (cm) |
|---|---|---|---|
| Parallelepiped | 3.5 cm | 6 cm | 0,6 cm |
| Parallelepiped | 7 cm | 11 cm | 0,6 cm |
| Cube | 1 cm | 1 cm | 1 cm |
COLLAPAT® II / COLLAPAT® DENTAL bone void fillers are presented in light- and water-proof double wrapping, one unit per box, except for the 1 x 1 x 1 cm pads which are presented in boxes containing five units.
COLLAPAT® DENTAL does not exist in the biggest size 7x11x0.6
For further information please contact us.
COLLAPAT®II bone void filler is CE marked by the notified body LNE / G-MED n°0459 and is a Class III Medical Device made by SYMATESE – Chaponost – FRANCE.
Contra-indications: For full list of recommendations for use and contra-indications, method of administration, please refer to the Instruction For Use of the product included in the box or click on “information for the patient”
Information for patients
The following document describes the regulatory content of the COLLAPAT® Patient Pages in order to answer to the article 18 of the Regulation 2017/745 concerning the Implant Card.
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