Commercialization of a Radiopaque Spherical Embolic Agent.

Uterine Fibroids are benign tumors that affect 70% of pre-menopausal women. These fibroids are the most common reason for hysterectomy amongst women. A new medical treatment called embolization can effectively treat these tumors without the need for hysterectomy. Embolization is an elegant, minimally invasive procedure that involves a specialist doctor inserting a long flexible tube (catheter) into a blood vessel in the groin of a patient. The doctor then guides the tube to the site of the fibroid (using live X-ray imaging) and injects tiny particles through the catheter. These particles block blood flow to the tumor, and cause it to shrink. This intervention quickly eliminates fibroid symptoms, without the need for hysterectomy. However, the procedure presently has significant risks. Firstly, the particles used to block blood flow are invisible to X-ray, which means that they can accidentally block blood flow to healthy tissue instead of the tumor. Secondly, because the particles are invisible, it is difficult to tell if the vessel feeding the tumor has been fully blocked - doctors cannot be sure the procedure is successful. Thirdly, to try and visualize the particles, doctors mix the particles with an X-ray dye. However, this dye is highly toxic and significantly impairs kidney function. Consequently there is a need for a particle that is fully visible on X-ray. The research team have developed and tested a new X-ray visible material for embolization called OccluRad. OccluRad has already been subjected to rigorous safety testing against commercial materials. The tests show that OccluRad is fully visible on X-ray, and is biologically safer than conventional materials. The final requirements to commercialize the device include making OccluRad spherical (the preferred form for clinical use), to establish sterilization criteria and to finalize biological testing. This research grant provides for each of these tests to expedite commercialization of the technology.