ストレートリンク● 細胞増殖抑制性能を示すリムス系薬剤BA9● 高い親油性により、素早く組織に浸透し、細胞に取り込まれます● 高い局所的バイオアベイラビリティ：●

標的病変への持続的な薬剤のリリースが可能8●

一般的なリムス系薬剤より半減期が長い8S-リンク

8.3x
GREATER TISSUERETENTION10MINIMALSYSTEMIC WASH-OF10STENTPLATFORM

vs Sirolimus

vs Sirolimus

10X MORE
LIPOPHILIC8VS OTHER LIMUS DRUGSLONG 20-DAY
HALF-LIFESMS

TREATMENT(ABLUMINAL SURFACE)
Powered by

BA9TM drug 10 times more lipophilic than Sirolimus

DCS

100

BA9 APPLICATIONDIRECTLY ON
THE STENT

806040200%Sirolimus

Zotarolimus

Everolimus

Biolimus A9TM+/-2.8%(valid for all drugs tested)

1. Ueki et al. Validation of Bleeding Risk Criteria (ARC-HBR) in Patients Undergoing Percutaneous Coronary Intervention and Comparison with Contemporary Bleeding Risk Scores. EuroIntervention. 2020 Feb 18. doi:
10.4244/EIJ-D-20-00052

ULTRA RESPONSIVE

2. Data from BioFreedom Ultra. Bolimus-A9 coated thin Strut Stents in High Bleeding Risk Patients Evidence from the LEADERS FREE III Study. F.R.Eberli et al., Presented at PCR eCourse June 2020

FO R AL L S T E P S
O F T H E P A T IE NT JO U R NE Y

3. Data from BioFreedom in LEADERS FREE: Urban P. et al. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk New England Journal of Medicine 2015, October 14, DOI: 10.1056/NEJMoa1503943
4. Data from Gazelle. Urban P. et al. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. New England Journal of Medicine 2015, October 14, DOI: 10.1056/NEJMoa1503943
5. Data from BioFreedom. Garot P et al. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. JACC VOL.6 9, No.2 , 2017
6. M. W. Krucoﬀ. Global Approach to High Bleeding Risk Patients With Polymer-Free Drug-Coated Coronary Stents: ﬔe LF II Study. Circ Cardiovasc Interv. 2020 Apr;13
7. S. Saito. LEADERS FREE Japan study (single BioFreedom DCS arm with 1-month DAPT, compared to BMS arm of LEADERS FREE). ePoster EuroPCR 2017
8. Biosensors International data on ﬁle
9. With BioFreedom compared to BMS. BioFreedon is the predicate device of BioFreedom Ultra
10. Sirolimus analog lipophilicity dictates release kinetics and tissue retention after implantation of polymer free drug eluting stents. R. Tzafriri, Poster Presentation EuroPCR 2017§. Struts for speciﬁc stent diameter (small vessel).

BioFreedom™ Ultraは、Biosensors International Group, Ltd.の登録商標です。

■ 販売名： BioFreedom Ultra 薬剤コーテッドステント

BioFreedom™ Ultraは、CEマークの承認を受けています。

■ 医療機器承認番号：30400BZX00081000［お問い合わせ先］

日本バイオセンサーズ株式会社〒101-0054

東京都千代田区神田錦町3-6 D'sVARIE神田錦町 3F

TEL.03-6811-7910 FAX.03-6811-7912

www.biosensors.com

BSJ202203TI2-500［製造販売元］DCS CoCr
LF Ⅲ2

DCS StS
LFⅠ3BMS
LFⅠ4(n=401)(n=1221)(n=1211)

Primary Safety Endpoint*

8.0%

9.2%

12.7%

Cardiac Death

3.7%

4.1%

5.1%

Myocardial Infarction

4.4%

5.9%

8.7%

Def/Prob. Stent ﬔrombosis

1.0%

2.0%

2.2%

Clinically-Driven TLR**

4.2%

4.9%

9.3%

BARC 3-5

5.4%

7.2%

7.2%

All Death

6.4%

7.5%

8.7%

Lesion Success

99%

98%

98%

Device Success

99%

98%

98%

Procedure Success

97%

94%

94%

Clinical outcomes at 1 year

L E A D I N G T H E WAY AT
DECISIVE MOMENTS
What if the choices you make today,
could allow you to focus on what matters most to you?

ULTRA EFFICACY

Procedural characteristics

40%

1

OF PATIENTSARE HBR* p-value for non-inferiority vs DCS LF I: 0.0006 (non-inferiority margin: 3.9%)** p-value for superiority vs BMS LF I: < 0.0001

LEADERS FREE LEGACY
WITH LONG TERM DATA

99%

2

EASE OF NAVIGATION
THROUGH TORTUOUS VESSELS

DEVICE SUCCESS

ALL-COMER HBR: HBR, HBR-ACS, UNCERTAIN§とステントデザイン、薄いコバルトクロム製ストラット（84μm）
改良されたデリバリーシステムの組み合わせにより、優れたトラッカビリティとプッシャビリティを発揮し、クロッサビリティを向上しました。

Ease of delivery
BA9TM UNIQUE DRUG
PROPERTIESSHORTENDAPTULTRA SAFETY

約28日間で、およそ98％のBA9がステントから放出されます8

LEADERS FREE Ⅲ2ST at 1 year

ULTRA REPRODUCIBLE
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）2,6,7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。

very late ST at 2 years

0.1%

DURING IMPLANTATION

Positibve outcomes reproducible to all patients
81%

LEADERS FREE5

AFTER IMPLANTATIONULTRA DELIVERABLEQUALITY OF LIFE

Eﬃcient procedure

BioFreedom™ Ultraは、手技時間を短縮することに貢献し、患者様の負担を軽減することが可能です。

BEFORE IMPLANTATION

51% Cardiac Death reduction in ACS Patientswith BioFreedomTM 3,7
1% ST at 1 year in HBR patientswith BioFreedomTM Ultra2

51%RRR

p=0.049

350,000

patients
treated

8Cardiac Death
GazelleTM BMS(n=329)BioFreedomTM
DCS(n=330)