PRODUCT OVERVIEW

biofreedom-ultra

LEADING THE WAY AT
DECISIVE MOMENTS

What if the choices you make today,
could allow you to focus on
what matters most to you?

biofreedom-ultr

特長

ULTRA REPRODUCIBLE

Positibve outcomes reproducible to all patients

3,000人のHBR患者を対象とした無作為化臨床試験
LEADERS FREE global clinical trial(I、II、III、Japan)では、
HBR患者の幅広い領域で治療効果の有意な改善が証明されています。

特長

製品情報

PRODUCT INFORMATION

製品表

*印のついている製品は在庫をご確認の上、ご注文ください。

  • ■ 販売名: BioFreedom Ultra 薬剤コーテッドステント
  • ■ 医療機器承認番号:30400BZX00081000
BioFreedom™ Ultraは、Biosensors International Group, Ltd.の登録商標です。
BioFreedom™ Ultraは、CEマークの承認を受けています。

コンプライアンスチャート

COMPLIANCE CHART

コンプライアンスチャート 表

アイコン

BIOFREEDOM™
FAMILY CLINICAL PROGRAM

BioFreedom™ - Company Managed Trials

特長

11855-000-EN_Rev.03d8

  • 1. BioLimus-A9™ coated thin strut stents in High Bleeding Risk patients Oral abstract presentation Eberli R. PCR e-course 2020
  • 2. Global Approach to High Bleeding Risk Patients With Polymer-Free Drug-Coated Coronary Stents: The LF II Study. M.W. Krucoff. Circ Cardiovasc Interv. 2020 Apr;13
  • 3. ePoster Dr Saito Euro PCR 2017
  • 4. Polymer-free Biolimus A9-coated stents in the treatment of de novo coronary lesions with short DAPT: 9-month angiographic and clinical follow-up of the prospective,
    multicenter BioFreedom USA clinical trial Waksman R. et al CRM 18 (2017) 475–481
  • 5. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. Garot P et al. JACC VOL.6 9, NO.2 , 2017
  • 6. Main results of the BioFreedom QCA trial. Sabate M. PCR e-course 2020
  • 7. Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions 4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial Costa R et al. J Am Coll Cardiol Intv 2016;9:51–64

BioFreedom™ - Physician Managed Trials

with support from Biosensors International*

特長

11855-000-EN_Rev.03d8

  • *   Biosensors has provided financial support for these PITs
  • 6. Randomised Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent with the Ultrathin Strut Biodegradable Polymer Sirol
    Treated with Percutaneous Coronary Intervention: The SORT OUT IX Trial. Published online Jensen L. 10.1161/CIRCULATIONAHA.119.0
  • 7. Safety and efficacy of polymer-free Biolimus eluting stents in all-comer patients: The RUDI FREE study Sardella G, et al. EuroIn
  • 8. Establishment of healing profile and neointimal transformation in the new polymer-free biolimus A9-coated coronary stent by lon
    assessments: the EGO-BIOFREEDOM study Lee SWL et al. EuroIntervention. 2018 Sep 20;14(7):780-788

BioFreedom™ - Trials

with no Biosensors International involvement

特長

11855-000-EN_Rev.03d8

  • 9. Angiographic and clinical performance of polymer-free biolimus-eluting stent in patients with ST-segment elevation acute myocardial infarction
    in a metropolitan public hospital: The BESAMI MUCHO study Gaspardone A Catheter Cardiovasc Interv.2017;00:1–8
  • 10. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk Windecker S, et al. N Engl J Med. 12th February 2020; 1-11

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