Q3 Medical Devices company amg International has secured CE mark approval for its UNITY-B fully biodegradable stent.
Designed for endoscopic use, the UNITY-B balloon expandable biodegradable biliary stent (BEBS) is said to compliment the pancreaticobiliary biodegradable implant called ARCHIMEDES.
The company is offering ARCHIMEDES stent in fast, medium, and long-lasting degradation profiles.
It secured CE mark approval in 2018 and was introduced into the market via a global distribution partnership with Medtronic.
The UNITY-B biodegradable stent, which is a large diameter balloon expandable implant, will enable the drainage of obstructed ducts requiring larger openings.
amg has designed the biodegradable stent to help eliminate the second removal procedures generally conducted by the traditional fully and partially covered self-expanding metallic stents.
According to the company, the UNITY-B stent demonstrated no adverse events and no serious adverse events in a recently conducted safety and efficacy clinical study.
Q3 Medical Devices CEO Eric Mangiardi said: “The CE mark approval of the UNITY-B stent represents yet another milestone for amg International and all the companies of Q3 Medical and our mission to ‘Create Value By Helping People’.
“In these uncertain times, being able to reduce the total cost of care using advanced, clinically proven products is more important than ever.”
According to the company, the amg biodegradable portfolio is designed to help gastroenterologists, surgeons and interventional radiologists to minimise the total cost of care and complications related with the older generation of non-biodegradable plastic and metallic implants.
Q3 Medical Devices is an Ireland based holding company with operations in Germany, China, and the US.
It is engaged in the development of novel bioresorbable, micro invasive, localised intraluminal drug delivery, and core products platforms for interventional cardiology, peripheral vascular, and non-vascular diseases.
