The data, which were presented at the European Society of Cardiology’s ESC Congress and published by The Lancet, showed a 6.2% TLF rate at 12-months for patients treated with Orsiro compared to 9.6% for patients treated with Xience.
The pivotal investigational device exemption trial was designed to support an upcoming premarket approval submission, Biotronik reported.
The study enrolled 1,334 patients and treated 884 with Orsiro and 450 with Xience.
After 12 months, patients with Orsiro had a 4.6% rate of target vessel myocardial infarction, compared to 8.3% of patients treated with Xience. The study also showed a 2% rate of clinically-driven target lesion revascularization for those treated with Orsiro compared to 2.4% for those treated with Xience.
“Orsiro’s rate of TLF shows an unprecedented improvement in DES outcomes compared with a control stent that has served as a standard in interventional cardiology,” principal investigator Dr. David Kandzari said in prepared remarks. “Orsiro also notably has exceptional deliverability that is essential for PCI procedures. We believe Orsiro’s ultrathin 60 micron struts, bioresorbable polymer and proven antiproliferative drug are the key elements to its superior performance.”
“At Biotronik, we’re committed to bringing proven innovation to market because we care about positively impacting lives. The data from the Bioflow-V study is evidence of the potential for Orsiro to enter the US DES market and become the standard of care in PCI,” president Marlou Janssen added. “Where Orsiro is available around the world, hospitals, physicians and patients can confidently rely on this drug-eluting stent to deliver exceptional results.”