Biotronik has released Orsiro, a drug-euting stent that combines an active biolute coating and a passive probio coating, on to the French market. The release comes after a succession of studies demonstrating the safety and efficiency of the stent in the treatment of discrete de-novo stenotic lesions and in-stent restenotic lesions.
Two studies, BIOFLOW-II and BIOFLOW-III, showed Orsiro performing as best in class. BIOFLOW-II was a prospective, international, multi-centre, randomised trial evaluating the safety and efficacy of Orsiro compared with Xience Prime. The BIOFLOW-II and -III subgroup analyses released this year demonstrated the top performance of Orsiro in the treatment of patients with small vessel disease and complex B2/C lesions, respectively. The results of the much larger investigator-initiated BIOSCIENCE trial, which compared Orsiro with Xience Prime in a larger patient population more reflective of routine clinical practice, have further confirmed the ultra-thin Orsiro as best in class. The BIOSCIENCE results were published in the prestigious general medical journal The Lancet.
“We have been tracking Orsiro closely as its use widens globally, waiting for it to come to us,” said Didier Carrié, interventional cardiologist, University Hospital of Toulouse, France, who was among the first to implant one of the new stents. “It is of great benefit to my practice that I am now able to offer treatment with Orsiro to patients here in France. Thanks to its bioabsorbable polymer coating, it is the best chance we have at minimising adverse events.”
Based on the PRO-Kinetic Energy platform, a company press release claims, Orsiro offers flexibility without compromising scaffolding or fatigue resistance, while a thinner 60 µm strut design ensures minimal vessel injury. The stent will be offered in up to 40mm lengths, making it one of the longest drug-eluting stents on the market. Its design allows for stent expansion without affecting the performance of the polymer coating, ensuring improved patient outcome when treating coronary artery stenosis, even in patients with particularly long lesions.