Newswise — 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, a developer, manufacturer and marketer of innovative medical devices, 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, MD, 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 Dr. 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™ drug-coated stent (DCS) has been implanted to date in more than 150,000 patients in more than 40 countries outside the United States. The BioFreedom™ DES has CE mark approval and is commercialized outside of the US. 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.