The Gandras catheter for uterine artery embolization: the procedure-driven development of a novel medical device.

Uterine artery embolization (UAE) is a safe and effective therapy for women suffering from symptomatic fibroid tumors of the uterus. In order to complete the procedure, the interventionalist must be able to catheterize both uterine arteries from a single femoral puncture site. The uterine arteries are subsequently embolized, or occluded, to stasis by injecting small particles mixed with radio opaque contrast under fluoroscopic guidance. Historically, it has been necessary to use several different catheters of varying shapes, lengths and materials to accomplish the catheterization of both uterine arteries when performing UAE. Every catheter exchange increases the length and difficulty of the procedure. The risk and radiation dose of any interventional radiological procedure is directly proportional to its overall duration. Thus if a single catheter could achieve the objective of catheterizing the bilateral uterine arteries for UAE throughout the procedure, its use would decrease the length of the procedure and consequently decrease the overall risk to the patient, thus representing an improvement over the technology currently available. The purpose of this paper is to outline the anatomical and technical considerations that governed the development of an ideal catheter to perform UAE, the Gandras catheter.