Instylla today announced that Ripal Gandhi (Baptist Health South Florida, Coral Gables, USA) has completed the first commercial procedure using the Embrace hydrogel embolic system (HES).
“Ongoing innovation is fundamental to how we continue to advance interventional radiology,” said Gandhi. “Our field relies on tools that allow us to treat complex disease with greater precision and procedural confidence. In this case, I was pleased that Embrace HES allowed me to achieve deep, distal penetration into the tumour vascular bed, which helped me tailor the embolization to the patient’s anatomy and treatment goals. It has been encouraging to see how Embrace HES has evolved with a focus on practical ease of use in the clinical setting. I look forward to further experience with this technology as we continue to evaluate how it can best support patient care.”
“I was pleased that Embrace HES allowed me to achieve deep, distal penetration into the tumour vascular bed,” said Gandhi.
This milestone marks the first patient treated with Embrace HES following US Food and Drug Administration (FDA) Premarket approval, granted in August 2025, for the embolization of hypervascular tumours in peripheral arteries ≤5mm. Approval was based on results from a prospective, randomised, multicentre pivotal study evaluating the safety and effectiveness of Embrace HES compared with standard of care transcatheter arterial embolization (TAE) and transarterial chemoembolization (cTACE).
Embrace HES consists of two low-viscosity liquid precursors that combine intravascularly when simultaneously injected, forming a soft, polyethylene glycol (PEG) hydrogel during the embolization procedure. This liquid embolic is designed to deeply penetrate the tumour vascular bed to create a rapid and sustained occlusion upon delivery and then liquifies via hydrolysis over approximately 11 months.
“This first commercial procedure represents an important milestone for Instylla and for the physicians who participated in the development of Embrace HES,” said Sean Boyle, chief executive officer of Instylla. “Following FDA approval, we are proud to see Embrace HES transition into clinical practice, providing physicians with a transformational embolic platform technology solving critical unmet needs for cancer patients with hypervascular tumours.”
