October 30, 2019

Biotronik's Orsiro DES Approved in China

October 30, 2019—Biotronik announced that its Orsiro coronary drug-eluting stent (DES) has been approved for sale in China by the National Medical Products Administration. The company expects to make the device available to Chinese patients and physicians in the coming months.

Approval in China was supported by results from the BIOFLOW-VI trial, which began enrollment in August 2015 to further demonstrate the safety and efficacy of the Orsiro DES. Professor Yuejin Yang, MD, serves as principal investigator of the BIOFLOW-VI.

In Biotronik’s announcement, Prof. Yang commented, “Orsiro will be a valuable addition to our percutaneous coronary intervention toolbox here in China due to its ultrathin 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.”

According to Biotronik, the safety, efficacy, and clinical performance of the Orsiro stent have been investigated in clinical studies with more than 48,500 patients enrolled to date. The device was approved in the United States in February 2019. It was approved in Japan in January 2019.

The company noted that the device has shown significantly lower rates of target lesion failure and target vessel myocardial infarction at 12 months in comparison to a durable-polymer, everolimus-eluting stent in the BIOFLOW-V study. The 12-month BIOFLOW-V data were presented in August 2017 at the European Society of Cardiology's ESC Congress 2017 in Barcelona, Spain, and published by David E. Kandzari, MD, et al in The Lancet (2017;390;1843–1852).

Additionally, recently released data from the BIOSTEMI randomized controlled trial demonstrated the Orsiro’s superiority over durable-polymer everolimus-eluting stent (DP-EES) with respect to target lesion failure rates at 12 months in patients presenting with ST-segment elevation myocardial infarction. On September 2, Biotronik announced the presentation of data from the BIOSTEMI randomized controlled trial at the European Society of Cardiology’s 2019 congress held August 31 to September 4 in Paris, France. The results were published in The Lancet (2019;394:1243-1253).


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