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A China-developed stent has achieved a first with a review by the prestigious medical journal The Lancet this week. For the first time in its 200-year history, The Lancet published on Tuesday a report on the clinical tests of a China-made device, the Firehawk rapamycin target eluting coronary stent, a drug-eluting stent developed by the Shanghai-based MicroPort Scientific Corp.
According to the journal, the stent could be a solution to a longstanding problem in the field of cardiovascular intervention.
“Ideally, the Firehawk stent is expected to solve the problem of blood clots after [heart] surgery, which could adversely influence cardiovascular intervention therapy,” said an expert at the Beijing Chaoyang Hospital who took part in the clinical test.
The MicroPort Scientific Corporation has spent 15 years developing the stent, finally adopting a polymer coating technology to precisely deliver the drug within the blood vessel and save patients who need post-surgery medication a great deal of money.
This target eluting design allows Firehawk to achieve the same level of clinical efficacy as the “best-in-class” drug-eluting stents, but with the lowest drug dosage to prevent restenosis, the company said.
Firehawk is MicroPort’s third-generation drug-eluting stent developed to treat patients with coronary artery disease. The drug and biodegradable polymer are eluted from microgrooves laser-cut on the abluminal side of the stent struts.
Firehawk also overcomes the late thrombosis event weakness inherent in drug-eluting stents while maintaining a long-term safety profile commensurate with traditional bare metal stents. Mortality from late thrombosis can be as high as 50%.
Publication of the study in The Lancet is a “landmark achievement” for the study of a drug-eluting stent manufactured in China, said Dr Zhaohua Chang, founder, chairman and CEO of MicroPort.
“With the Firehawk clinical results having been validated in such a rigorous peer-reviewed publication, clinicians and patients should have every confidence in the safety and efficacy of Firehawk to treat patients with coronary artery disease,” he added.
The stent has also been tested at some hospitals in Europe without letting participating doctors and volunteers know the origin of the device.
Initial trial sales of the new stents will start next year in hospitals in China, pending regulatory approval by the Chinese food and drug administration.