Biosensors has announced that the first patient has been enrolled in LEADERS FREE II—the BioFreedom pivotal study, which is being conducted under an investigational device exemption (IDE). The study includes sites in the USA, Canada, Denmark, France Germany, Italy, and the UK and will be evaluating the use of the BioFreedom drug-coated stent. A press release reports that the stent has been implanted to date in more than 150,000 patients in more than 40 countries outside the USA.
According to the press release, the initiation of LEADERS FREE II marks a key milestone on the path towards obtaining FDA approval for the BioFreedom device. Similar to LEADERS FREE, the therapeutic focus of this new US pivotal IDE trial is on patients at high bleeding risk who receive an ultra-short dual antiplatelet drug regimen of only one month.
Keith Oldroyd (Golden Jubilee National Hospital in Glasgow, Scotland) performed the first LEADERS FREE II implant earlier this week and says: “We are excited to participate in the European arm of the BioFreedom drug-coated stent US Pivotal IDE study and further contribute to building the high-bleeding risk patient experience for potential expansion of the availability of BioFreedom to American patients.”
The study is being conducted under the leadership of Mitchell W Krucoff (Duke University, USA), who will be the principal investigator, and Philip Urban (La Tour hospital in Geneva, Switzerland), who is the co-principal investigator in Europe. The chairman of the executive physician committee is Marty Leon (Columbia University, New York, USA). Urban comments: “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.”