Artimplant recalls its odontology product Bone Scaffold from the market
Västra Frölunda, Sweden, November 21, 2006
Artimplant recalls its odontology product Bone Scaffold intended to increase bone volume of bone defects in the mouth. The Company has acquired data showing that necessary bone formation is not achieved.
The product has been implanted in less than 20 patients.
As communicated in the third quarter interim report 2006, Artimplant develops a new design that is expected to better meet the functional demands. Clinical evaluation is planned to be performed during 2007.
Artimplant CEO, Hans Rosén says;
“Bone Scaffold has been used by a selected number of clinics with the purpose of increasing bone volume, mainly in the upper jaw at so called sinus lift. Data from six months follow up show that so called osteoid tissue, the initial phase of bone formation is integrated into Artelon®, but mineralized bone is not formed. Because of this, Artimplant has decided to recall the product from the market. In consultation with clinicians we believe we may have identified the problem as too small pores in the product. Our plan is to further develop Bone Scaffold by changing the structure of the material.