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

Resolute Onyx Stent With Improved Radiographic Visibility Found to Be Safe and Effective
News | Stents Drug Eluting | October 01, 2018
October 1, 2018 — Recent results from the BIONYX randomized clinical study showed the novel, thin-strutted, polymer-c
Boston Scientific Receives FDA Approval for Eluvia Drug-Eluting Vascular Stent
Technology | Stents Drug Eluting | October 01, 2018
Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA)...
Eluvia Drug-Eluting Stent Demonstrates Superior Patency in IMPERIAL Trial
News | Stents Drug Eluting | September 26, 2018
Positive 12-month data from the late-breaking IMPERIAL trial was presented at the 2018 Transcatheter Cardiovascular...
Titanium-Nitride-Oxide Stent Superior to Bioabsorbable DES in Acute Coronary Syndrome Patients

Image courtesy of Hexacath

News | Stents Drug Eluting | May 31, 2018
Late-breaking trial results presented at the EuroPCR Congress, May 21-24 in Paris, France, found the Optimax titanium-...
Orsiro DES Shows Lowest Two-Year Target Lesion Failure in BIO-RESORT Trial
News | Stents Drug Eluting | May 31, 2018
Two-year outcome data from the BIO-RESORT randomized controlled trial were presented in a late-breaking clinical trials...
OCT Reveals Excellent Healing Profile for Complex CAD Patients With Resolute Onyx DES
News | Stents Drug Eluting | May 29, 2018
Investigators recently unveiled clinical data from the independently run Onyx 1-Month OCT Study showing strong early...
Abbott's Xience Sierra Stent Receives FDA Approval
Technology | Stents Drug Eluting | May 25, 2018
Abbott announced it received approval from the U.S. Food and Drug Administration (FDA) for Xience Sierra, the newest...
Medtronic Launches 2 mm Onyx DES
Technology | Stents Drug Eluting | February 26, 2018
February 26, 2018 – Designed specifically for small vessels, Medtronic plc announced U.S.
Detroit Medical Center Heart Hospital Uses Michigan's First EluNIR Drug-Eluting Stent
News | Stents Drug Eluting | February 19, 2018
February 19, 2018 — The Detroit Medical Center’s (DMC) interventional cardiology team at Heart Hospital recently beca
Biotronik Symposium Highlights Differing Roles of Drug-Eluting Stents and Magnesium Scaffolds in Clinical Practice
News | Stents Drug Eluting | January 25, 2018
January 25, 2018 – Data presented at the Biotronik-sponsored...
Overlay Init