Zeitschrift für Materialwissenschaften und Ingenieurwesen

Translational Development of Biocompatible X-Ray Visible Microspheres for Use in Transcatheter Embolization Procedures

Abstract

Benzina A, Aldenhoff YB, Heijboer R and Koole LH

Embolization is a minimally invasive treatment that specifically blocks the arterial blood flow into a target blood vessel bed, which is usually a benign or malignant tumor. The aim of the procedure is to shrink the tumor and/or to retard its growth. Embolization the injection of embolic particles via a catheter tube, of which the tip has been navigated carefully (under X-ray guidance) into an arterial branch that exclusively feeds the tumor, and no surrounding healthy tissues. Most of the clinical experience with embolization relates to treatment of leiomyomata (benign tumors growing in the wall of the uterus). There is solid evidence that catheter-based embolization of leiomyomata provides a fully acceptable therapeutic alternative for much more demanding surgical procedures (i.e., hysterectomy and myomectomy). Embolization offers much faster recovery, possible options to become pregnant, and considerable cost saving. There are several commercial brands of embolization agents, suitable to treat leiomyomata. We hypothesized, some years ago, that these products are suboptimal, and that embolization of leiomyomata may be improved further through better engineering of the embolic particles. We developed injectable radiopaque polymer microspheres, which can be monitored during and after the embolization procedure. The embolic microbeads are X-ray traceable, and this has been achieved without compromising other essential properties, such as structural stability and excellent biocompatibility. Herein, we describe new the features of the new embolic microspheres, as observed in preclinical experiments and in the first clinical cases. It is mentioned briefly that this work became an example of successful translation: it has led to a new medical device (Class-IIB) that is now CE-certified and commercially available throughout Europe.