Locally produced degradable heart stent passes early test
Biodegradable cardiovascular stents produced locally have been approved.
A biodegradable cardiovascular stent produced in Shanghai has passed the National Medical Products Administration's evaluation.
One way of treating coronary artery disease is by implanting cardiovascular stents. Clinical results for both drug-eluting and bare-metal stents are encouraging.
However, their ongoing presence can lead to dangerous complications like blood clots. It can cause severe problems like thrombosis, heart attacks, and strokes.
MicroPort, a Shanghai-based producer of medical devices, has revealed that its Firesorb stent can completely degrade inside patients' bodies and lower the risk of clotting to 0.34 percent.
Over 11 million people in China suffer from coronary diseases, and the incidence of mortality keeps on rising.
A heart stent is a useful medical intervention. While the drug-eluting stent has a high risk of blood clots, bare metal can result in a 15-30 percent relapse of narrow arteries.
Biodegradable stents are now the main focus of both domestic and international medical equipment industry research. Numerous businesses have been working on the development of biodegradable stents since 2000, but most of the first generation of these devices have a significant risk of blood clots.
MicroPort said it has created a high-polymer substance on its own to construct the new generation of stents and invented the Firesorb stent because there were no vendors to fulfill the huge demand. It carried out a five-year clinical trial with 1,468 participants. The stents have broken down into carbon dioxide and water, significantly lowering the risk of a clot.
"These findings demonstrate the efficacy and safety of the locally-made biodegradable stents," said a leading expert on the clinical trial and Chinese Academy of Engineering academic Dr Gao Runlin. "It is a very encouraging result for both patients and the medical field."
