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.
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).
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.
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.
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%.
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.