A drug-coated heart stent has become the first of its kind from China to pass clinical trials for use in Europe, a key step on the road to entry into the overseas market.
The Firehawk – China’s first drug-releasing heart stent – performed on par with global leader Xience, according to the results of the trials published in the medical journal The Lancet this month.
The Firehawk is designed by the Shanghai-based health care company MicroPort Scientific while Xience was developed by the American firm Abbott.
The clinical trials for the made-in-China stent involved more than 1,600 patients at 21 hospitals in 10 European countries between December 2015 and October 2016.
The trials were open to anyone with coronary artery disease requiring medical intervention, regardless of the patient’s age and severity of illness.
The results were then put through a peer review process.
“Firehawk was found to be as safe and effective as Xience after testing in a large randomised post-market study and compared against the market’s leading drug-coated stent,” said Alexandra Lansky, a lead author of the study.
Lansky is a professor of cardiovascular medicine at Yale University in the United States and a researcher with the Barts Heart Centre at Queen Mary University in Britain.
The next step in the process is for MicroPort to submit documentation for European Union approval.
Stents – tiny tubular devices used to prop open narrowing heart arteries – have been used widely for nearly three decades.
Implanting a scaffolding stent into the diseased artery of the heart is a standard treatment for coronary artery disease.
Made of stainless steel or cobalt alloy, the mesh tubes of conventional stents are usually less than 3mm in diameter and about 1cm long.
In 2003, the United States approved drug-coated stents, a more expensive version of the device that could also…
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