147-21 | Instylla HES Hypervascular Tumor Pivotal Study

Overview

“Group Study to Evaluate the Safety and Effectiveness of the Instylla Hydrogel Embolic System (HES) Compared with Standard of Care Transcatheter Arterial Embolization (TAE) / Transcatheter Arterial Chemoembolization (cTACE) for Vascular Occlusion of Hypervascular Tumors; A Pivotal Study”

The purpose of this study is to evaluate the safety and performance of a new embolization device, the Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter, compared to the standard of care: transarterial embolization (TAE) or conventional transarterial chemoembolization (cTACE). These types of embolization devices are used to reduce or completely close off the blood supply to a targeted area that needs to be treated. Some embolization devices are also used to deliver a chemotherapeutic agent to the tumor. During TAE, a catheter (a thin, flexible tube) is put into an artery in the inner thigh or wrist through a small cut and eased up into the targeted area for embolization. A dye is usually injected into the bloodstream to help the doctor watch the path of the catheter. Once the catheter is in place, the embolization device is injected into the artery to stop blood flow and potentially slow or stop the growth of a tumor. cTACE involves TAE administration of one or several chemotherapy drugs which may or may not be followed by embolization of the tumor-feeding vessels with the embolic device. In order to compare the investigational HES to standard of care treatment, 2/3 of the study participants will receive HES and 1/3 will have standard of care treatment.