Instylla has announced the enrolment of the first patient in the HALT study for the treatment of peripheral arterial bleeds. The HALT study is a prospective, multicentre, single-arm study to evaluate the safety and effectiveness of the Embrace hydrogel embolic system (HES) for the embolization of arterial bleeding in solid organs and peripheral arteries.
According to the American Association for the Surgery of Trauma (AAST), injury is a major public health problem accounting for over 150,000 deaths and over 3 million non-fatal injuries annually. Traumatic injuries, specifically pelvic and hepatic injuries, are the leading causes of haemorrhage in trauma patients. Transcatheter arterial embolization (TAE) has played an increasingly significant role in controlling haemorrhage, with an efficacy rate of 81%–100% in unstable pelvic fractures for example.
Acute gastrointestinal bleeding has a mortality rate ranging from 4% to 10%. TAE facilitates highly selective embolization of bleeding vessels, with clinical success rates of 74.7% in treating acute upper gastrointestinal bleeding.
“We are excited to have enrolled the first patient nationally in the prospective HALT study, evaluating an innovative, in situ-forming liquid embolic for haemorrhage control in patients,” commented David Tahour, chief of vascular and interventional radiology at MemorialCare Long Beach Medical Center (Long Beach, USA). “Embrace HES has demonstrated rapid and durable haemostasis in preclinical studies while reducing the risk of non-target embolization. I look forward to being involved with this innovative technology which will change the standard of care for future embolizations.”
The HALT study is led by Suvranu Ganguli, section chief, interventional radiology at Boston Medical Center (Boston, USA). The study is estimated to enrol 118 patients at up to 25 US sites. Patients with upper gastrointestinal bleeds, kidney, liver, or spleen bleeds, spontaneous haematomas, or other peripheral arterial bleeds such as pelvic haemorrhage may be considered suitable for this study.
“I would like to thank Dr Tahour and his team for their effort in achieving this significant clinical milestone,” said Amar Sawhney, Instylla CEO. “We are excited to study the performance of the Embrace HES in this additional indication, which reflects the versatility of this novel liquid embolic.”