News | Stents Drug Eluting | March 03, 2017

Biosensors Announces Enrollment of First Patient in New U.S. Pivotal BioFreedom Trial

LEADERS FREE II IDE trial will assess therapeutic value of drug-coated stent in patients at high bleeding risk on ultra-short dual anti-platelet therapy

Biosensors, BioFreedom drug-coated stent, LEADERS FREE II IDE trial, first patient, U.S. pivotal study

March 3, 2017 — Biosensors International Group Ltd. announced in February enrollment of the first patient in LEADERS FREE II, its new BioFreedom Pivotal Study. The study will be conducted under an Investigational Device Exemption (IDE), which will include sites in the United States, Canada, Denmark, France Germany and Italy. 

The BioFreedom drug-coated stent (DCS) has been implanted to date in over 150,000 patients in more than 40 countries outside the United States. The initiation of LEADERS FREE II marks a key milestone on the path towards obtaining U.S. Food and Drug Administration (FDA) approval for the BioFreedom DCS. Similar to LEADERS FREE, the therapeutic focus of this new U.S. pivotal IDE trial is on patients at high bleeding risk (HBR) who receive an ultra-short dual anti-platelet drug regimen of only 1 month.

Prof. Keith Oldroyd performed the first LEADERS FREE II implant at the Golden Jubilee National Hospital in Glasgow, Scotland and stated: “We are excited to participate in the European arm of the BioFreedom DCS U.S. Pivotal IDE study and further contribute to building the HBR patient experience for potential expansion of the availability of BioFreedom to American patients.”

The study is conducted under the leadership of Mitchell W. Krucoff, M.D., from Duke University, North Carolina, as principal investigator and Philip Urban, M.D., from La Tour hospital in Geneva, Switzerland, who is the co-principal investigator in Europe. The chairman of the Executive Physician Committee is Marty Leon, M.D., Columbia University, New York.

Urban commented: “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.”

For more information:

Related Content

American College of Cardiology Expands Patient Navigator Program
News | Cath Lab | March 21, 2018
March 21, 2018 — Hundreds of hospitals across the United States will have access to tools and resources to help impro
Videos | Cath Lab | March 15, 2018
A discussion with Hitinder Gurm, M.D., MBBS, FACC, professor, internal medicine, and associate chief clinical officer
News | Cath Lab | February 27, 2018
The American College of Cardiology (ACC) and the Saudi Arabian Cardiac Interventional Society have partnered to...
News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
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
Overlay Init