In 80% of clinical trial patients, Ethizia stopped bleeding in 30 seconds – an average of six times faster than the leading commercially-available sealant patch.
Ethicon, a Johnson & Johnson MedTech company based in Raritan, New Jersey, has announced the approval of Ethizia, an adjunctive hemostat solution which has been clinically proven to achieve sustained hemostasis in difficult to control bleeding situations.
Comprised of unique synthetic polymer technology, the patch is said to be the first and only hemostatic matrix designed to be equally active and efficacious on both sides.
Designed for maximum adaptability, it can be stuffed, rolled, pulled apart, trimmed and tailored, making it easy to handle in both open and minimally invasive surgeries. In 80% of clinical trial patients studied, the patch stopped bleeding in 30 seconds – an average of six times faster than the leading commercial sealant patch.
In May 2022, Ethicon acquired GATT Technologies, a Netherlands-based company using differentiated synthetic polymers to create hemostatic and sealant products to address complex surgical bleeding and leak challenges.
The acquisition of GATT and the addition of its synthetic technology complements Ethicon’s current capabilities, enabling the development of solutions that address critical unmet needs.
In 2021 GATT announced the first successful implant of its patch at the Radboud university medical centre in Nijmegen in The Netherlands.
The flexible, fibrous sheet was highly efficiently dry impregnated with synthetic activated POx-polymers, produced using the technology of Fibroline, based in Lyon, France, following an ongoing collaboration.
The first patient implant marked the start of a multi-centre clinical trial that was conducted by three leading academic medical centres in the Netherlands.
Now, as marketed by Ethicon, the Ethizia hemostatic sealing patch has received CE Mark approval as an adjunctive hemostat for disruptive bleeding on internal organs, except cardiovascular and neurological, and is expected to launch in EMEA in the first quarter of 2024, and other key markets in North America, APAC and LATAM following regulatory approvals.