News | January 31, 2013

Biosensors Receives CE Mark Approval for BioFreedom

Stent is among the first DES released to market without a drug-carrying polymer

BioSensors International BioFreedom Drug Coated Stent CE mark

January 31, 2013 — Biosensors International has announced CE mark approval for its polymer-free drug-coated stent (DCS), BioFreedom.

BioFreedom represents the latest development in Biosensors’ stent technology, featuring a micro-structured abluminal surface, which permits the controlled release of Biolimus A9 (BA9) without the use of a polymer. BA9 is a highly lipophilic anti-restenotic drug developed by Biosensors specifically for use with stents.

CE mark approval for BioFreedom was supported by strong data from the BioFreedom First in Man study. In this study BioFreedom was compared to Boston Scientific’s Taxus Liberté drug-eluting stent (DES). At 12 months, BioFreedom demonstrated equivalent efficacy, measured by in-stent late lumen loss, compared with Taxus Liberté, with a trend towards superiority. Median in-stent late lumen loss in patients receiving BioFreedom was reduced to 0.17 mm as compared with a median in-stent late lumen loss of 0.35 mm in the Taxus Liberté group. Three-year clinical results, presented at TCT in October 2012, showed similar rates of MACE (major adverse cardiac events) between BioFreedom and Taxus Liberté, with no evidence of stent thrombosis in either group.

To further evaluate BioFreedom in a larger patient population, Biosensors recently announced initiation of enrolment in LEADERS FREE, the world’s first prospective, randomized double-blind trial between a DCS and bare-metal stent (BMS), exclusively involving patients at high risk of bleeding. The study has been designed to confirm that BioFreedom is as safe as a BMS in this patient group, and can deliver the anti-restenotic benefit of a DES, with only a one-month course of dual anti-platelet therapy administered to all patients.

This trial will provide additional data to support the launch of BioFreedom in select markets during 2013. The full commercial launch is currently anticipated during 2014.

For more information: www.biosensors.com

Related Content

Baylis Medical and Siemens Co-Sponsor Transseptal Access Training Course
News | EP Lab| October 18, 2017
Baylis Medical Co. Inc. and Siemens Healthineers are co-sponsoring a first-of-its kind training program aimed at...
Societies Issue New Performance and Quality Measures for Treating Patients with Heart Attack
News | Cath Lab| October 17, 2017
The American College of Cardiology and the American Heart Association recently released updated clinical performance...
First Patient Enrolled in U.S. Arm of ALIVE Pivotal Heart Failure Trial
News | Heart Failure| October 17, 2017
October 17, 2017 — BioVentrix Inc. recently announced enrollment of the first patient in the U.S.
Dee Dee Wang runs Henry Ford Hospital's 3D printing lab for its complex structural heart cardiology program.

Dee Dee Wang, M.D., runs Henry Ford Hospital's 3-D printing lab that supports its complex structural heart program.

Feature | 3-D Printing| October 13, 2017 | Dave Fornell
Three-dimensional (3-D) printed anatomic models created from a patient’s computed tomography (CT), magnetic resonance...
Videos | Chronic Total Occlusion (CTO)| October 09, 2017
Bill Lombardi, M.D., director of complex coronary artery interventions at the University of Washington, discusses the
BTG Acquires Roxwood Medical
News | Business| October 05, 2017
BTG plc announced it has acquired Roxwood Medical, provider of advanced cardiovascular specialty catheters used in the...
TVA Medical Receives CE Mark for Next-Generation EverlinQ 4 EndoAVF System
News | Vascular Access| October 04, 2017
TVA Medical Inc. announced that its everlinQ 4 endoAVF System has received CE Mark in the European Union. The...
Reflow Medical's Wingman Crossing Catheter Receives FDA Clearance for Coronary Indication
News | Catheters| October 02, 2017
October 2, 2017 — Reflow Medical Inc. announced that the company has received 510(k) clearance from the U.S.
TherOx Gains FDA PMA Approval for SSO2 Therapy System
Technology | Cath Lab| September 29, 2017
September 29, 2017 — TherOx Inc. announced that the U.S.
Avinger Receives CE Mark for In-Stent Restenosis Indication With Pantheris Image-Guided Atherectomy
Technology | Atherectomy Devices| September 29, 2017
Avinger Inc. recently announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the...
Overlay Init