our news
JAPANESE PMDA APPROVAL FOR BIOFREEDOM™ ULTRA AND US FDA APPROVAL FOR BIOFREEDOM™
April 21, 2022 | News | BioFreedom™ JAPAN + USA
Biosensors International is pleased to announce both Japanese PMDA approval for BioFreedom™ Ultra on 31st March 2022 and also US FDA approval for BioFreedom™ on 14th April 2022.
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Biosensors International Announces Enrollment of First Patient in Pivotal Trial of New Coronary Microcatheter - "BIOMICS".
April 05, 2022 | News | Microcatheter
The BIOMICS study is a prospective, multi-center evaluation of the safety and effectiveness of the Biosensors Microcatheter in patients undergoing Percutaneous Coronary Intervention (PCI) for the treatment of chronic total occlusions (CTO).
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BIOSENSORS INTERNATIONAL ANNOUNCES ENROLLMENT OF FIRST PATIENT IN NEW SEMI-COMPLIANT BALLOON TRIAL “RISE SC STUDY".
February 4, 2022 | News | Drug-eluting Balloons
This ongoing trial will evaluate the performance of the new RISETM SC balloon which will complete the Biosensors International balloon portfolio.
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The primary endpoint of BIO-RISE CHINA was presented at TCT 2021 Late Breaking Trials
November 7, 2021 | News | Bio-Rise China
This first-in-human study assessed the safety and efficacy of a Biolimus A9™ coated balloon and showed excellent results in small vessels with 0.16 mm late loss at 9 months.
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TWO-YEAR RESULTS FROM THE BIOMATRIX ALPHA REGISTRY PUBLISHED IN JOURNAL OF INTERVENTIONAL CARDIOLOGY
April 29, 2021 | News | BioMatrix Alpha
MACE 7.2% Cardiac Death 1.3% MI 2.8% & ST 1.1%.
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CE Mark Approval for Biolimus A9™ Coated Cobalt Chromium Coronary Stent System BioFreedom™ Ultra
October 19, 2020 | News | BioFreedom™ Ultra
BioFreedom™ Ultra is Biosensors International new, novel thin strut CoCr polymer and carrier-free Drug Coated Stent with Biosensors proprietary limus BA9™, a highly lipophilic anti-restenotic drug, developed specifically for use in coronary vascular applications. BioFreedom™ Ultra successfully extends the LEADERS FREE legacy in LEADERS FREE III.
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