Instylla has secured premarket approval from the US Food and Drug Administration (FDA) for its Embrace Hydrogel Embolic System (HES), designed for peripheral vascular embolisation.
The approval allows Embrace HES to be used for the embolisation of hypervascular tumours in peripheral arteries measuring 5mm or less.
Hypervascular tumours, often found in organs like the liver, kidney, and bone, are characterised by an increased number of blood vessels, complicating surgical removal due to bleeding risks.
For patients with limited disease progression or for controlling local tumours, transcatheter arterial embolisation (TAE) and transarterial chemoembolisation (cTACE) remain standard treatments.
Embrace HES operates by injecting two low-viscosity liquid precursors into blood vessels, where they crosslink to form a polyethylene glycol hydrogel. The hydrogel is intended to penetrate the tumour’s vascular bed, effectively halting blood flow.
The FDA’s approval followed a pivotal study that assessed Embrace HES against standard care options like TAE and cTACE.
Conducted across 22 global sites, the study involved 150 patients with hypervascular tumours, with participants randomly assigned in a 2:1 ratio to receive either Embrace HES or standard treatments.
The study’s findings demonstrated that Embrace HES achieved an 88.6% technical success rate, verified by an independent core lab, said the company.
The device also showed a 99% rate of freedom from major adverse events, as determined by a Clinical Events Committee. Notably, no adverse events were attributed solely to the device.
University of California, Irvine interventional radiology chief Dr Nadine Abi-Jaoudeh and the study’s national principal investigator Nadine Abi-Jaoudeh said: “The pivotal trial was designed to evaluate the Embrace HES system in patients with hypervascular tumours.
“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.
“Delivered as two liquid precursors that polymerise in situ to minimise non-target embolisation, 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 IR repertoire.”
Instylla CEO Sean Boyle said: “We are incredibly proud to receive FDA approval for Embrace HES, offering a transformational embolic platform technology solving critical unmet needs for cancer patients with hypervascular tumours.
“This milestone represents years of innovation and dedication of our team to advancing interventional oncology. More importantly, it brings new hope to patients and their families facing the challenges of cancer.”
