The Chinese National Medical Products Administration has granted market approval to Biotronik’s sirolimus-eluting Orsiro stent. A press release reports that the company expects to make the device, which has a biodegradable polymer, available to Chinese patients and physicians in the coming months. As the second largest drug-eluting stent market in the world, China is the next major country to approve Orsiro. In the last two years, the stent has become available in other important markets such as Japan and the USA.
According to the press release, safety, efficacy and clinical performance of the Orsiro stent have been investigated in clinical studies with more than 48,500 patients enrolled to date. Significantly lower rates of target lesion failure and target vessel myocardial infarction were observed at 12 months in comparison to a durable polymer everolimus-eluting stent in the BIOFLOW V study. In addition, according to data from the BIOSTEMI trial, Orsiro has demonstrated superiority over durable polymer everolimus-eluting stent with respect to target lesion failure rates at 12 months in patients presenting with ST-segment elevation myocardial infarction (STEMI).
Yuejin Yang, principal investigator of the BIOFLOW VI study, says: “Orsiro will be a valuable addition to our percutaneous coronary intervention (PCI) toolbox here in China due to its ultra-thin stent characteristics. In our investigation we demonstrated that the treatment outcome of Orsiro was comparable to the current clinical standard in a Chinese population. Based on the data we have seen in other recent studies such as BIO RESORT and BIOSCIENCE, Orsiro may also offer unique benefits in certain indications.”
Gunnar Wochnowski, regional vice president Asia Pacific at Biotronik, comments: “Biotronik has reaffirmed its commitment to making their proven technologies available in China and investing in the wider Asia-Pacific region. We are bringing our lifesaving technology to Chinese hospitals, because patients and physicians deserve the best. With its extensive clinical data and ultrathin design, physicians can rely on Orsiro to treat even challenging patient groups.”