Hidroxiapatita Porosa Coralina Hap-200. 15 Años de Aplicaciones Clinicas.

Coralline Porous Hydroxyapatite HAP-200 is a biomaterial for bone implants developed for more than 15 years in Cuba and it has been applied with success as bone graft substitute and as integrated ocular implant. In this paper we report summarized information of the main results obtained in the development stage and clinical applications of this product. This biomaterial in the shape of blocks and spheres with different dimensions as well as granulated with different sizes of the particles has been evaluated keeping in mind all the parameters of its clinical and preclinical behavior according to the evaluation and registration standards of biomaterials of the CCEEM at the MINSAP of Cuba. They have been carriying out several protocols of clinical trials, as controlled as multicentrics, of postproduction and study of the clinical behavior at long term, of introduction in the national system of health as well as studies and design of the productive system and of management of the quality that endorse the obtainment several certificates of registry in Cuba and in some foreign countries and abroad as well as the certificates of good manufacture practice. During the 15 years of clinical applications in Cuba 9 613 patients have been treated in odontology and maxilofacial surgery specialties, 783 people have received ocular implant and 2 592 have been treated on bony defects of the long bones and others in orthopedics and traumatology. Only 3,2 % of failure has been reported and the causes are associated to the surgical treatment and in any case caused by the biomaterial, demonstrating that the latter has an excellent biocompatibility with integration and incorporation to the natural dynamics of the bone tissue. The obtained results are excellent not only from the point of view of the characteristics and properties of the biomaterial but also for its behavior "in vivo" and the impact in health and life quality of our population. [ABSTRACT FROM AUTHOR]