J&J’s Ethicon gets CE mark approval for ETHIZIA haemostatic sealing patch
16 Nov 2023
AcquisitionClinical ResultDrug Approval
Made from synthetic polymer technology, ETHIZIA is an adjunctive haemostat solution designed to achieve sustained haemostasis in difficult to control bleeding conditions
Ethicon has received European approval for ETHIZIA sealing patch. (Credit: Debora Alves from Pixabay)
Johnson & Johnson MedTech’s Ethicon, a surgical instruments maker, has received the CE Mark for the ETHIZIA haemostatic sealing patch.
ETHIZIA is an adjunctive haemostat solution designed to achieve sustained haemostasis in difficult to control bleeding conditions.
Made from synthetic polymer technology, the sealing patch is said to be the first and only haemostatic matrix designed to be equally effective and active on both sides.
According to Ethicon, the patch allows easy handling in both open and minimally invasive procedures due to its maximum adaptability design.
Additionally, ETHIZIA can be packed, rolled, pulled apart, trimmed, and tailored.
The haemostatic sealing patch stopped bleeding in 30 seconds in 80% of the patients who were examined in a clinical trial.
The results were equal to an average of six times faster than the leading Fibrin Sealant Patch, the Johnson & Johnson MedTech company said.
Ethicon company group chairman Vladimir Makatsaria said: “As a global leader in surgery, we are committed to empowering healthcare providers to safeguard patients from surgical complications by continuously delivering breakthrough solutions.
“Disruptive bleeding can contribute to serious complications, and with the addition of ETHIZIA to our portfolio, we are well positioned to deliver critical haemostasis solutions for patients.”
The surgical instruments maker has received European approval for the sealing patch as an adjunctive haemostat for internal organs’ disruptive bleeding with the exception of cardiovascular and neurological.
With regulatory permissions in place, ETHIZIA is anticipated to launch in Q1 2024 across Europe, the Middle East and Africa (EMEA) and other markets in North America, Asia–Pacific (APAC), and Latin America.
In May last year, Ethicon acquired Netherlands-based GATT Technologies, which is engaged in the development of haemostatic and sealant products by using synthetic polymer to handle difficult surgical bleeding and leak issues.
The synthetic technology from GATT and the company’s acquisition enhances Ethicon’s existing capabilities to create new solutions including ETHIZIA haemostatic sealing patch for critical unmet needs.
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