Chinese device for heart disease passes muster in Europe

A stent for treating coronary artery disease, known as the Firehawk, that was invented by researchers in Shanghai has been found safe and effective in European patients.

In a clinical trial involving 1,653 patients in Europe at 21 sites between December 2015 and October 2016, no significant differences were observed in the stent when compared with the global-standard product, the Xience stent, by healthcare company Abbott. Both are drug-delivering stents that are coated with medication.

A stent is a device that expands inside a blocked artery to keep it open so that blood can flow through.

Data observed 12 months after implantation of both the Firehawk and the Xience stent showed only a slight difference in indicators for cardiac arrest, myocardial infarction and the stent thrombosis rate. The rate of revascularization was lower in the Firehawk stent.

A paper about the clinical trials after the invention of the stent by Shanghai MicroPort Medical (Group) Co was published on Tuesday on the website of the Lancet, a world-leading medical journal based in the United Kingdom.

The stent achieves the same level of clinical effectiveness as the best-performing drug-delivering－or drug-eluting－stents, with the lowest drug dosage so far in the world, the company said.

"The clinical trial confirms that the Firehawk stent is safe and effective across a broad spectrum of patients and lesion complexity," said the paper's lead author, Alexandra Lansky of the Yale University School of Medicine.

Zheng Ming, vice-president of clinical medical affairs at the Shanghai company, said: "The Firehawk stent solved the dilemma between the late thrombosis event weakness of the drug-eluting stents and the low efficacy of the bare metal stents－the two main categories of stents currently used worldwide. It combines the advantages of both categories: high efficacy and longterm safety."

Late thrombosis is an extremely dangerous event for such patients, and the death rate can be as high as 50 percent, doctors said.

The innovation was that the drug is eluted from laser-cut micro grooves on the abluminal side of the stent struts, the researchers said, and the surface area of all the grooves on the stent is less than 5 percent of the total surface area of the stent while the remaining 95 percent of the stent surface remains bare metal.

"The process of laser cutting involves digging nearly 600 grooves on a hard metal as thin as hair," Zheng said.

Chang Zhaohua, founder, chairman and CEO of Micro-Port, called the research a landmark, given that it's the first time that clinical data from a drug-eluting stent manufactured in China has been published in such a prestigious medical journal.

"We strongly believe and expect that the Firehawk stent, which made its market debut in Chinese hospitals in 2014 and has been approved for use and marketed in 36 countries and regions, will save millions of global patients in the years to come," he said.

According to the China Cardiovascular Disease Report 2017 published by the National Center for Cardiovascular Diseases in May, there are 290 million patients in China, and they are becoming younger. The number of male patients between 35 and 44 increased by 111 percent in the past 15 years. Altogether, 750,000 intervention treatments for coronary disease were carried out that year.