Biosensors has announced that the US Food and Drug Administration (FDA) recently granted conditional investigational device exemption (IDE) approval for a US-based clinical trial of the BioFreedom polymer-free drug-coated stent system.
The BioFreedom US IDE Feasibility Trial is designed to collect additional safety and effectiveness data for the BioFreedom system and to support a future pivotal IDE study. The company believes this is the first clinical study within the USA evaluating polymer-free drug-coated stent, and also the first US clinical study of a device benefitting from the use of the Biolimus A9 (BA9) drug. The trial design is multicentre and prospective, enrolling 100 patients at up to five centres. Due to the unique features of BioFreedom, the FDA agreed with a post-implant strategy requiring only three months of dual anti-platelet therapy for this study.
Another important BioFreedom trial, LEADERS FREE, is applying for a one-month dual anti-platelet therapy strategy in patients at high risk of bleeding to further establish the product’s safety and efficacy profile. The goal is to demonstrate that treatment with BioFreedom delivers the safety profile of a bare-metal stent with the anti-restenotic benefit of a drug-eluting stent.
BioFreedom represents the latest development in Biosensors’ stent technology, featuring a micro-structured abluminal surface that permits the controlled release of BA9 without the use of a polymer or other carrier. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents. In its First in Man (FIM) study, treatment with BioFreedom demonstrated excellent 12-month late lumen loss and sustained safety up to four years, including absence of definite and/or probable stent thrombosis.
BioFreedom received CE mark approval in January 2013 and is currently available in limited and selected markets.