Selectively Micro-Structured
Surface
(SMS)
ステントの内腔側表面にのみSMS加工(Selectively Micro-Structured surface)を施すことで、
BA9™を微細構造化された表面内に閉じ込めることが出来るため、冠動脈病変の血管壁に高い特異性をもってBA9™を
到達させることが可能となりました。
SMSプロセスにより、表面積が増加し、標的病巣にBA9™を均一に投与することが可能になりました。
BA9™とSMS加工により、ポリマーやキャリアを必要としないBioFreedom™ Ultraは、真の薬剤コーテッドステントになります。
BIOFREEDOM™
FAMILY CLINICAL PROGRAM
BioFreedom™ - Company Managed Trials
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*
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 Sirolimus-Eluting Stent in an All-comers Population
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
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