First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent

May 12, 2017 — PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and effectiveness of a new stent to treat patients with coronary heart disease who are at higher risk for bleeding.

Biosensors International Group Ltd is testing its BioFreedom drug-coated stent in the LEADERS FREE II Pivotal Study, with the therapeutic focus on patients at high bleeding risk (HBR) who can only receive an ultra-short dual anti-platelet regimen of only one month. William Bachinsky, M.D., FACC, medical director of cardiac catheterization labs at PinnacleHealth CardioVascular Institute, serves locally as principal investigator at PinnacleHealth.

Coronary artery disease is the narrowing or blockage of vessels that carry blood to the heart muscle, effecting millions of Americans and results in symptoms of shortness of breath, chest pain, heart attack and death. Blockages of the heart arteries are often treated with stents, thin metallic scaffolds that are implanted to help open the artery and alleviate these issues. Most patients require two anti-platelet medications for the first few months after the procedure, which for some patients is a concern because of an increased risk for bleeding. An option to reducing the length of time needed for these extra blood thinners would be favorable for HBR patients.

“We are very excited to be the first to treat a Pennsylvania patient in the global study testing a heart stent that may require shorter dual antiplatelet medication for patients with coronary heart disease,” said Bachinsky. “The polymer-free BioFreedom stent may allow us to address the unmet need of our patients, who are at higher risk for bleeding, but require treatment with an active stent.

The BioFreedom DES has CE mark approval and is commercialized outside of the United States. The LEADERS FREE II trial will be conducted at up to 85 clinical sites in the United States, Canada, Denmark, France, Germany, Italy and the United Kingdom.

Read the article “Biosensors Announces Enrollment of First Patient in New U.S. Pivotal BioFreedom Trial”

Read the article “Polymer-Free Drug-Coated Stents More Effective Than Bare-Metal Stents in High Bleeding Risk Patients”

Read the article “BioFreedom Trial Demonstrates Comparable Long-Term Safety, Efficacy to Conventional DES”

For more information: www.biosensors.com