Instylla, Inc. announced premarket approval (PMA) from the FDA for the company’s flagship Embrace hydrogel embolic system. The device has been approved for the embolization of hypervascular tumors in peripheral arteries ≤ 5 mm.
According to the company, Embrace HES consists of two low-viscosity aqueous liquid precursors that interact to crosslink intravascularly when simultaneously injected into blood vessels during the embolization procedure to form a soft, polyethylene glycol (PEG) hydrogel. The liquid embolic is designed to deeply penetrate the tumor vascular bed, crosslink, and stop blood flow, stated the company.
Instylla advised that the PMA for the Embrace HES was granted based on results from a prospective, randomized, multicenter pivotal study that evaluated its safety and effectiveness for the embolization of hypervascular tumors compared to the standard of care (SOC): transcatheter arterial embolization or transarterial chemoembolization.
The Instylla HES hypervascular tumor pivotal study was conducted at 22 global institutions and enrolled 150 patients with hypervascular tumors who were randomized 2:1 to receive either Embrace HES or SOC treatment.
The company reported that Embrace HES met both primary safety and effectiveness endpoints, demonstrating 88.6% technical success as confirmed by an independent core lab and 99% freedom from major adverse events, as adjudicated by a Clinical Events Committee. There were no adverse events classified as device-related only, noted Instylla.
The National Principal Investigator of the study is Nadine Abi-Jaoudeh, MD, Chief of Interventional Radiology at the University of California, Irvine, in Orange, California.
“The pivotal trial was designed to evaluate the Embrace HES system in patients with hypervascular tumors,” commented Dr. Abi-Jaoudeh in the company’s press release. “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.”
Dr. Abi-Jaoudeh continued, “Delivered as two liquid precursors that polymerize in situ to minimize nontarget 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 IR repertoire.”