Shanghai firm's innovative stent approved by FDA

A  pharmaceutical company based in Shanghai Friday announced that what it calls the world's first innovative, targeted-drug-delivery stent for coronary disease has been approved by the State Food and Drug Administration.

Unlike traditional drug-delivery stents with the drug coating the entire stent, the stent developed by MicroPort in Shanghai uses a groove in the stent to hold the drug targeting the artery wall. It uses only one-third the amount of the drug required by a traditional stent.

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 stented artery.

The stent is usually placed within the coronary artery by doctors during an angioplasty procedure.

But traditional drug-delivery stents have been found to lead to a risk of a blockage, or thrombus, caused by a new clot in the long term. Polymers in those stents have been shown to be the main cause of that problem.

A polymer is a compound that has large molecules made up of many relatively simple repeated units.

"The new stent with less drug and less polymer can greatly reduce of risk of thrombus," said Luo Qiyi, chief technology office of MicroPort.

There are 29 million people with cardiac vascular diseases in China and many people with coronary disease need stents.