China’s first drug-releasing heart stent passes clinical trials in Europe
Device developed by Shanghai company performs on par with global leader in clinical trials
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.
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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 deliver medicine to prevent treated arteries from reclogging.
In a 2015 study, researchers at the Technical University of Munich in Germany found in that patients who used bare-metal stents suffered a higher rate of reclogging within 30 days of installation compared with those with received drug-coated ones.
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But there was a higher incidence of clotting with drug-coated stents over the longer term, according to the study. The German researchers said the drugs used in the coated stents could be the cause of the blood-clotting risk.
MicroPort said it used the lowest possible dosage of medication on the device, reducing the chance of an adverse reaction in the blood.
Chinese drug-coated stents are up to half the price of imported ones, selling at about 10,000 yuan (US$1,455), and have around 70 per cent of the domestic market. But the international market is dominated by players such as Abbott, Boston Scientific and Medtronic, which together have about 90 per cent of the global market share, according to consultancy GlobalData.
Cardiovascular diseases kill 17.3 million people around the world each year, according to the World Health Organisation. And China has one of the highest rates of the disease in the world, with the condition accounting for two in five adult deaths in the country, the World Heart Federation said.
Annually, heart stents are used in more than 2 million patients worldwide. But for every 100 patients, five have severe complications and two die suddenly from stent failure, according to an international research team The Coronary Atlas.