Medical devices firm Biosensors International Group has begun enrolment in the US pivotal clinical trial (LEADERS FREE II) of its BioFreedom drug-coated stent (DCS) in high-bleeding risk (HBR) patients.
Being conducted under an Investigational Device Exemption (IDE), the trial includes sites in the US, Canada, Denmark, France Germany, Italy and the UK.
While the stent has been implanted in more than 150,000 patients in more than 40 countries outside the US, the current trial is being conducted to obtain the US Food and Drug Administration (FDA) approval for the device.
The first implant for the trial was performed at the Golden Jubilee National Hospital in Glasgow, Scotland, by Professor Keith Oldroyd.
Oldroyd said: “We are excited to participate in the European arm of the BioFreedom DCS US Pivotal IDE study and further contribute to building the HBR patient experience for potential expansion of the availability of BioFreedom to American patients.”
The trial will be conducted in HBR patients, who will be given an ultra-short dual anti-platelet drug regimen for one month.
The study's principal investigator in Europe Philip Urban said: "The results of the LEADERS FREE trial underscore the need to improve treatment of patients at high-bleeding risk throughout the world.
"With the development of the BioFreedom stent, Biosensors has successfully addressed an unmet need for a patient population that had been very largely overlooked.”
Equipped with the firm's stent technology, BioFreedom has a micro-structured abluminal surface to allow the controlled release of the lipophilic anti-restenotic drug BA9 without the use of a polymer or a carrier.
Image: BioFreedom stent. Photo: courtesy of Biosensors.