Biosensors International Group has obtained a conditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate a US-based clinical trial of its BioFreedom polymer-free drug-coated stent (DCS) system.
Featuring a micro-structured abluminal surface, the BioFreedom DCS permits the controlled release of a highly lipophilic anti-restenotic drug, Biolimus A9 (BA9), without the use of a polymer.
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.
According to the company, this is the first clinical study within the US evaluating polymer-free DCS, and also the first US clinical study of a device benefitting from the use of the Biolimus A9 (BA9) drug.
The multi-centre and prospective trial will enroll around 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 (DAPT) for this study.
In addition, to establish the product's safety and efficacy profile, LEADERS FREE, BioFreedom trial is applying a one-month DAPT strategy in patients at high risk of bleeding.
The objective of this trial is to confirm that BioFreedom is as safe as a bare-metal stent (BMS) in this patient group, and can deliver the anti-restenotic benefit of a drug-eluting stent (DES), with only a one-month course of DAPT.
BioFreedom demonstrated fruitful 12-month late lumen loss and sustained safety up to four years in its first-in-man (FIM) study. The polymer-free DCS also demonstrated no evidence of definite or probable stent thrombosis.
Biosensors International Group CEO Dr Jack Wang said IDE approval for the BioFreedom US trial represents a major milestone for the company because it is its first US-based clinical study of a stent.
"The US is the largest national market for medical devices," Wang said. "We look forward to introducing our unique and ground-breaking interventional cardiology products there."
Earlier in January 2013, the company obtained CE Mark approval for BioFreedom and is currently available in limited and selected markets.
Image: Biosensors announces IDE approval for BioFreedom US trial. Photo: courtesy of Biosensors International Group, Ltd.