Atrium Medical Devices Being Sold in Australia Despite Breaking U.S. Quality Guidelines
A COMMONLY used lifesaving stent that prises open blocked arteries of heart attack victims is being sold in Australia even though its manufacturer breached US quality guidelines.
Our own medical regulator the Therapeutic Goods Administration (TGA) also identified problems at the US factory during an inspection but is still allowing the device to be sold here.
The stent is used in 135 Australian hospitals and in nine out of ten patients who receive a balloon expandable covered stent (Atrium Advanta v12 stent) during cardiac procedures.
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Our own medical regulator the Therapeutic Goods Administration (TGA) also identified problems at the US factory during an inspection but is still allowing the device to be sold here.
The stent is used in 135 Australian hospitals and in nine out of ten patients who receive a balloon expandable covered stent (Atrium Advanta v12 stent) during cardiac procedures.
Help employers find you! Check out all the jobs and post your resume.