by Xinhua writers Guo Ying, He Xinrong
BEIJING, Sept. 8 (Xinhua) -- China's self-developed heart stent has won recognition from the international medical community, with its clinical trial results published online in the world-leading medical journal The Lancet earlier this week.
Named Firehawk, the drug-eluting stent was developed by MicroPort Scientific Corporation, a Chinese healthcare company, to treat patients with coronary artery disease.
The metal stent is 86 microns thick, which is roughly the diameter of a human hair. It contains drugs in micro grooves engraved by lasers on the surface, which prevents the drug from leaking during the transportation of the stent.
Clinical trials were conducted in 21 hospitals in 10 European countries from December 2015 to October 2016. Altogether 1,653 patients from the UK, France, Spain, Italy, Belgium, the Netherlands, Poland, Germany, Austria, and Denmark were implanted with the stent.
According to William Wijns, a professor from the National University of Ireland Galway who led the clinical study, this is the first time that China's medical device went through randomized clinical trials in Europe at such a scale.
Results showed that the safety and clinical efficacy of this stent could rival the Xience stent, one of the world's leading drug-eluting stents.
In addition, its unique structure design could save drug dosages, which help prevent side effects such as thrombus after implantation.
According to Chang Zhaohua, CEO of MicroPort Scientific Corporation, they conducted the clinical trial to further test the stent and compare the results with world-leading heart stents.
"The clinical program adopted European medical standards and was operated by European authoritative experts. We hope to win wider recognition from the international medical community," Chang said.
He said this is the first time that clinical data from a China manufactured stent has been published in such a prestigious medical journal.
"The Lancet is very strict about publishing articles, and the review cycle often lasts for months, sometimes even more than a year. It took less than a month for the journal to publish the clinical trial of the stent, and all five peer review experts gave positive feedback," Chang said.
"With its clinical results being validated in such a rigorous peer-reviewed publication, clinicians and patients may have more confidence in the safety and efficacy of the stent," he added.
According to statistics from the National Cardiovascular Center, there were 290 million cardiovascular patients in China in 2017, including 11 million patients with coronary heart disease.
China has a huge demand for medical devices such as heart stents. The market used to be dominated by costly foreign products.
Many Chinese healthcare companies have increased their research and development in high-end medical devices, making them more affordable to the public.
In addition to the heart stent, Chinese companies are making significant progress in developing cost-effective medical devices such as heart pacemakers and automatic protein analyzers.
"We hope the Firehawk stent can help cure more patients on a global scale. We also want to boost Chinese people's confidence in domestic medical products," Chang said.