Local heart stent proved safe in large-scale European study
The Firehawk targeted-drug-delivery heart stent developed by MicroPort in Shanghai's Zhangjiang High-Tech Park in Pudong.
The world's first targeted-drug-delivery heart stent developed by a local company has proved to be safer and more effective than similar products after a global clinical study.
The Firehawk stent for coronary disease, developed by MicroPort in Shanghai's Zhangjiang High-Tech Park in Pudong, features a groove to hold drugs targeting the artery wall.
It uses only one-third the amount of the drugs required by a traditional stent, the lowest amount among similar products in the world, according to a report on the year-long study released over the weekend.
A stent is a small scaffold inserted into a narrowed, diseased coronary artery to hold it open and help prevent a heart attack. They typically contain drugs that are released slowly to prevent cell proliferation that could block the artery.
A total of 1,653 patients using the Firehawk stent from 21 hospitals in 10 European countries, such as the United Kingdom, Spain, France, Italy, Belgium, Netherlands, Germany and Denmark, took part in the study between December 2015 and October 2016.
Traditional drug-delivery stents have been found to lead to a risk of a blockage, or thrombus, caused by a new clot over the long term.
However, the stent developed by MicroPort has an extremely low rate of blockage or other failures, according to the report.
William Wijns, a professor with the National University of Ireland Galway who led the study, said their data showed the exceptional performance and safety of the Firehawk stent.
"Firehawk has the potential to positively impact patient care by further reducing the risk of late adverse events and the need for device-mandated prolonged therapy," he added.
It is the first time a domestically manufactured medical device has featured in such a large scale clinical study in Europe, Zheng Ming, vice president of clinical science and medical affairs for MicroPort said. Further experiments and studies will be carried out on the stent to prove its safety and reliability.
There are 29 million people with cardiovascular diseases in China, many of whom need stents.
Hong Kong-listed MicroPort Scientific Corporation was established in Shanghai in 1998. It has become a leading medical device company with business focusing on the innovation, manufacturing, and marketing of domestically manufactured medical devices globally.
