News | Stents Drug Eluting | May 12, 2017

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

PinnacleHealth CardioVascular Institute offers new treatment for heart artery blockages

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  

 

 

Related Content

Videos | Cath Lab| January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab| January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab| November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab| November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab| November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab| November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Three-Year Quality of Life Improvements Similar for PCI and CABG in Left Main Disease
News | Cath Lab| October 30, 2017
October 30, 2017 — New study results from the EXCEL trial comparing the quality of life (QoL) of patients with left m
Corindus Evaluates Incorporating HeartFlow Technology With CorPath GRX System
Technology | Cath Lab| October 26, 2017
Corindus Vascular Robotics Inc. announced that it will incorporate the HeartFlow FFRct (fractional flow reserve-...
Shockwave Medical Announces $35 Million in New Financing
News | Cath Lab| October 24, 2017
October 24, 2017 — Shockwave Medical reported $35 million in new financing, an extension of the company’s previously
Overlay Init