Biosensors has announced enrolment of the initial patient in BioFreedom USA, an investigational device exemption (IDE) feasibility trial designed to collect additional US-based safety and effectiveness data for BioFreedom, the company’s novel polymer and carrier-free drug-coated stent. The company believes this is the first clinical trial within the USA to evaluate a polymer-free drug-coated stent. Results from this study will support a future pivotal IDE study in the USA.
According to a company press release, the trial design is multicentre and prospective, enrolling up to 100 patients at up to 10 centres. Due to the unique features of the BioFreedom drug-coated sent, the FDA has approved a post-implant strategy requiring only three months of dual anti-platelet therapy (DAPT) for this trial. The initial patient has been enrolled in the trial by principal investigator Ron Waksman (MedStar Washington Hospital Center, Washington DC, USA).
“I am very excited to be involved in this first U.S. study of a drug-coated stent”, commented Waksman. “This will hopefully prove to be the first step towards FDA approval of BioFreedom, offering US patients all the benefits of a drug-eluting stent but with a shorter DAPT requirement.”
The BioFreedom US IDE feasibility trial is enrolling patients with symptomatic ischaemic heart disease due to de novo native coronary artery lesions. The primary safety endpoint of the study is the occurrence of MACE (a composite of cardiac death, myocardial infarction, target lesion revascularization and definite stent thrombosis) within nine months following stent implantation. The primary efficacy endpoint is in-stent late lumen loss at nine months compared with a historical control.
Another important BioFreedom trial, LEADERS FREE, is currently applying a one-month DAPT strategy in patients at high risk of bleeding to further develop 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.