The body of the
microbeads in ArteSense is made of polymethylmethacrylate (PMMA).
PMMA has been used safely in implants since the 1930’s. The beads are very
pure and produced by a suspension polymerization method, in contrary to
crushing or grinding.
The PMMA bodies are
covered with bovine collagen from a 3.5% atelocollagen solution. The
collagen layer is degraded by the body and replaced by the body's own
connective tissue. Pre-clinical and clinical studies demonstrate that the
size of the microbeads also play a
role in the end result of the
implantation by determining the amount of fibrous tissue, stimulated by
the injected implant. The distinct size of the microbeads avoids
phagocytosis by macrophages and local dislocation of the microbeads.
Atelocollagen
The substance used as a carrier for the microbeads is the collagen
derivative atelocollagen. The gel-like properties (thixotropy) of the
collagen and its derivatives make it an ideal carrier for ArteSense
(under normal conditions the gel prevents microbeads precipitation,
whereas under pressure it becomes liquid, thus enabling injection).
Atelocollagen results from the enzymatic removal of the antigenic ends of
the collagen molecule. It has been proven that this form of collagen
minimizes the risk of allergic reactions. The collagen used as raw
material in the preparation of ArteSense is extracted from bovine
skins. Only skins from approved safe sources that have been analysed and
declared BSE free by national veterinary authorities are used for the
extraction
