Instylla, Inc., a privately held innovator in resorbable embolic technologies for peripheral vascular embolization, has announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for its flagship product, the Embrace™ Hydrogel Embolic System (HES). The approval covers the use of Embrace HES for the embolization of hypervascular tumors in peripheral arteries measuring ≤ 5mm.
An abnormal growth in blood vessels characterizes hypervascular tumors (HVTs), which are commonly associated with poor survival rates and are found in the liver, kidney, bone, and other organs. Their high vascularity often makes surgical removal challenging due to increased bleeding risk. For patients with localized or limited progressive disease, or when tumor control is the primary goal, transcatheter arterial embolization (TAE) and transarterial chemoembolization (cTACE) remain well-established treatment approaches.
The two low-viscosity aqueous liquid precursors used in the Embrace HES technology crosslink within the vasculature to form a soft polyethylene glycol (PEG) hydrogel when they are concurrently injected into blood arteries during the embolization process. This liquid embolic is engineered for deep penetration into the tumor’s vascular network, where it solidifies to halt blood flow.
FDA approval was based on data from a prospective, randomized, multicenter pivotal study comparing Embrace HES to the standard of care (TAE or cTACE). The trial, which was carried out at 22 locations throughout the world, involved 150 patients who were randomized 2:1 to receive either normal treatment or Embrace HES. Results showed the device achieved an 88.6% technical success rate, with 99% of patients experiencing no major adverse events, and none of the events were solely device-related.
Clinical investigators highlighted the system’s unique ability to penetrate vessels as small as 10 microns, minimize non-target embolization, and avoid catheter entrapment. Additionally, its lack of imaging artifacts enables more accurate follow-up assessments.
Instylla’s leadership expressed pride in the FDA’s approval, noting the milestone as a culmination of years of innovation aimed at addressing unmet needs in cancer care and expanding treatment possibilities for interventional radiologists worldwide.
