Biosensors’ LEADERS FREE II BioFreedom Pivotal Study Begins Enrollment
February 15, 2017—Biosensors International Group, Ltd. announced that it has started enrollment in the new BioFreedom pivotal study, called LEADERS FREE II. The study will be conducted under an investigational device exemption (IDE) in the United States, Canada, Denmark, France, Germany, Italy, and the United Kingdom.
The company describes the BioFreedom as a drug-coated stent (DCS) that features a microstructured abluminal surface that permits the controlled release of BA9 without the use of a polymer or carrier. Biosensors developed BA9, a highly lipophilic antirestenotic drug, specifically for use with the company’s stents.
Per Biosensors, the therapeutic emphasis of the new pivotal IDE trial is similar to LEADERS FREE clinical trial, in that it focuses on patients with high bleeding risk who receive an ultrashort dual antiplatelet drug regimen of only 1 month.
Biosensors’ announcement states the BioFreedom DCS has been implanted in more than 150,000 patients across more than 40 countries, outside the United States. Professor Keith Oldroyd, who performed the first LEADERS FREE II implantation at the Golden Jubilee National Hospital in Glasgow, Scotland earlier this week, commented in the company’s press release, “We are excited to participate in the European arm of the BioFreedom DCS 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.”
Philip Urban, MD, Coprincipal Investigator of the study in Europe also commented in the company’s announcement, “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.”