First patients enrolled in the Embrace hydrogel embolic system global randomised multi-centre clinical trial

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Embrace
Representative images of arterial embolization in a rabbit kidney with Hydrogel Embolic System. Image panel includes a) baseline angiogram of right kidney, b) hydrogel embolic delivery under fluoroscopy c) digital subtraction angiography confirming stasis and embolization (inlay non-subtracted), and d) microscopic image showing hydrogel embolic (stained with trypan blue) in vessels large and small <25 um.

The initial patients have been enrolled in the Embrace hydrogel embolic system (HES) global randomised clinical trial for the treatment of hypervascular tumours, Instylla has announced. As demonstrated previously in the completed first-in-human (FIH) study, Embrace HES was effective at embolizing malignant and benign hypervascular tumours by blocking tumour blood supply with complete technical success and persistent embolization as noted in imaging follow up at 30-days.

“I am pleased to be evaluating this new technology for hypervascular tumour embolization,” comments Gerard Goh, head of Interventional Radiology at The Alfred Hospital, Melbourne Australia, and president of the Interventional Radiology Society of Australasia (IRSA). “While participating in the first-in-human study prior to this trial, Embrace showed great promise with good control, favourable patient outcomes, and no tumour revascularisation. We are excited to be the first centre to enrol in this global, randomised trial.”

A hypervascular tumour, which can be found in the liver, kidney, or elsewhere, has an increased number of blood vessels relative to other tissues. These tumours are often associated with low survival rates. Due to the increased risk of bleeding, hypervascular tumours can be challenging to remove. Transcatheter arterial embolization (TAE) and conventional transarterial chemoembolization (cTACE) are established treatments for hypervascular tumours, particularly for patients with limited progressive disease. Embrace HES, an investigational product, is a liquid embolic designed to deeply penetrate the tumour vascular bed, solidify, and stop blood flow. The Embrace HES embolization uses no solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment. Its main components are water and polyethylene glycol (PEG). PEG has a long history of safe use in implantable medical devices, Instylla claim.

“We are thrilled to be the first centre in the USA to treat a patient on this study. Embrace’s predictability helps me embolize the tumour while avoiding non-target embolization,” adds Edgar D St Amour, interventional radiologist from CARTI Cancer Center in Little Rock, USA. “I look forward to continued evaluation of this new advancement in treating hypervascular tumours.”


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