MicroPort, a Shanghai-based enterprise, has announced that its next-generation biodegradable heart stent, Firesorb, has received regulatory approval from the National Medical Products Administration, heralding a new era of hope for coronary heart disease patients.

This innovative stent not only completely degrades inside the human body, but also addresses the global challenge of high thrombosis rates associated with degradable heart stents.

Clinical studies have shown that Firesorb has an actual thrombosis rate of only 0.34 percent, according to the company.

Ge Junbo, an academician of the Chinese Academy of Sciences and chief of Cardiology at Fudan University's Zhongshan Hospital, said that the heart stent has a thickness of 100-125 microns, allowing for rapid degradation. Wang Jian'an, also an academician of the Chinese Academy of Sciences and professor at the Second Affiliated Hospital of Zhejiang University's School of Medicine, noted that compared to existing mainstream metal stents, Firesorb boasts a lower thrombosis rate thanks to its innovative design and manufacturing technology.

MicroPort established itself as a leader in the global field of heart stents in 2014 with the release of its innovative coronary rapamycin drug-eluting stent, aptly named Firehawk. The research findings of this product were published in the top international medical journal The Lancet. In 2009, MicroPort started to research and develop bioabsorbable stents, which eventually led to the release of Firesorb.

Bioabsorbable stents, which can support diseased blood vessels in the short term and completely degrade within the human body in the long term, are hailed as the "future of heart stents". However, previous bioabsorbable stents faced the challenge of high thrombosis rates among patients. In 2011 and 2016, a well-known American company's bioabsorbable stents were launched in Europe and the United States, only to face high clinical thrombosis rates 2-3 years after the intervention surgeries, leading to the product's withdrawal from the market in 2017.

MicroPort's research revealed two main reasons for the high thrombosis rates brought by the stents: excessively thick stent walls and high drug loads. Based on multiple technological breakthroughs, the Shanghai-based company established the core processes for bioabsorbable stents, making Firesorb the first domestically produced stent capable of full-size lesion coverage and the only stent suitable for treating small vessel lesions with a diameter of 2.5 millimeters. Clinical studies involving 1,468 patients have shown that Firesorb can restore diseased blood vessels to their original state and completely degrade into water and carbon dioxide three years after implantation.

Source: Jiefang Daily