New liquid embolic agent for hypervascular tumors gains FDA’s premarket approval
Instylla, a Massachusetts-based medtech company, has received premarket approval from the U.S. Food and Drug Administration (FDA) for its Embrace Hydrogel Embolic System (HES).
Embrace HES, the company’s flagship product, includes two low-viscosity aqueous liquid precursors that work together when injected into a patient’s blood vessels to form a soft hydrogel. It was designed to “deeply penetrate the tumor vascular bed, cross link and stop blood flow” during the embolization of hypervascular tumors in peripheral arteries ≤ 5mm. This reduces the bleeding risk during these procedures, making them a much safer treatment option for a wider selection of patients.
“This milestone represents years of innovation and dedication of our team to advancing interventional oncology,” Sean Boyle, CEO of Instylla, said in a statement. “More importantly, it brings new hope to patients and their families facing the challenges of cancer. We are motivated and committed to delivering technically advanced, clinically impactful solutions that empower interventional radiologists and expand therapeutic options across a broad range of vascular conditions.”
The FDA’s decision was largely based on data from a pivotal trial that focused on 150 patients with hypervascular tumors treated at one of 22 different facilities around the world. These patients either underwent treatment with Embrace HES or the standard of care. Overall, Embrace HES was linked to a technical success rate of 88.6% and a freedom from major adverse event rate of 99%.
“Embrace HES is the first liquid embolic approved specifically for this indication, with a unique design that enables deep penetration into vessels as small as 10 microns,” Nadine Abi-Jaoudeh, MD, chief of interventional radiology at the University of California, Irvine, said in the same statement. “Delivered as two liquid precursors that polymerize in situ to minimize non-target embolization, the cohesive embolic also avoids catheter entrapment. Additionally, Embrace HES does not have any imaging artifacts, allowing us to assess follow-up imaging with confidence. The trial met both its safety and efficacy endpoints, and I am excited to have this wonderful new tool in the interventional radiology repertoire.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.