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: www.biosensors.com


Related Content

News | Cath Lab

September 13, 2023 — A diagnostic test, first offered in the United States at University Hospitals (UH) Harrington Heart ...

Home September 13, 2023
Home
News | Cath Lab

August 2, 2023 — Teleflex Incorporated, a leading global provider of medical technologies, announced the U.S Food and ...

Home August 02, 2023
Home
News | Cath Lab

July 13, 2023 — Mount Sinai Queens announced the opening of a new cardiac catheterization lab that will provide rapid ...

Home July 13, 2023
Home
News | Cath Lab

June 21, 2023 — Royal Philips, a global leader in health technology, announced it has teamed up with BIOTRONIK (Lake ...

Home June 21, 2023
Home
News | Cath Lab

May 16, 2023 — Royal Philips, a global leader in health technology, announced late-breaking data from the DCR4Contrast ...

Home May 16, 2023
Home
News | Cath Lab

March 14, 2023 — Royal Philips, a global leader in health technology, and the Gibraltar Health Authority, announced they ...

Home March 14, 2023
Home
News | Cath Lab

March 1, 2023 — SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for ...

Home March 01, 2023
Home
News | Cath Lab

May 31, 2022 — Innovative Health, LLC, a specialty cardiology reprocessor, announced that the company has received ...

Home May 31, 2022
Home
News | Cath Lab

May 26, 2022 — The U.S. Food and Drug Administration (FDA) has recalled the Dragonfly OpStar Imaging Catheter, and has ...

Home May 26, 2022
Home
News | Cath Lab
April 25, 2022 – NewYork-Presbyterian Hudson Valley Hospital celebrated the launch of its interventional cardiology ...
Home April 25, 2022
Home
Subscribe Now