Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent.
Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.”
“Orsiro will be a valuable addition to our [percutaneous coronary intervention] toolbox here in China due to its ultra-thin stent characteristics,” Dr. Yuejin Yang, principal investigator in Biotronik’s BioFlow VI study, said in prepared remarks. “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.”
Biotronik won pre-market approval from the FDA for Orsiro in February. China is the world’s second-largest DES market, according to the company.
“We are bringing our life-saving technology to Chinese hospitals because patients and physicians deserve the best,” added Asia Pacific VP Gunnar Wochnowski. “With its extensive clinical data and ultra-thin design, physician can rely on Orsiro to treat even challenging patient groups.”