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Orsiro® Mission DES

Even better deliverability for the outstanding Orsiro DES1.
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Find out how Orsiro Mission can benefit your daily practice.

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Full system

* Nominal strut thickness for size ø 2.25 - 3.0 mm, mean diameter 62 μm.

The next level of deliverability1

1st in Push3

Transmits more force from hub to tip.

1st in track3

Less force needed to follow the path.

1st in Cross3

Less force needed to successfully cross demanding anatomies.

Ultrathin struts4 – thinnest available in the US5

For early endothelialization

When a unique design translates into clinical benefits

BIO-RESORT trial

Small vessels. Ultrathin struts. Big difference.

Small vessel subgroup analysis (n = 1,506) of a large scale all-comers BIO-RESORT (n = 3,514) trial.

Lower target lesion revascularization (TLR) rate compared to Resolute Integrity at 36 months.11

Δ Images: Secco G et al. Time-related changes in neointimal tissue coverage following a new generation. SES implantation: an OCT observational study. Presented at: euro PCR, May 20, 2014; Paris, France.
n = number of struts analyzed.

Strut thickness in perspective8
Orsiro
BIOTRONIK

CoCr-SES 60 μm*

Synergy
Boston Scientific

PtCr-EES, 74 μm

Resolute Onyx9,10
Medtronic

CoNi-ZES, 81 μm

Xience Family
Abbott

CoCr-EES, 81 μm

*Nominal strut thickness for size ø 2.25 - 3.0 mm,
mean diameter 62 μm.

Outstanding patient outcomes12

ONE OF THE MOST STUDIED DES◊

STUDY NAME STUDY TYPE PATIENTS STATUS PRIMARY ENDPOINT
BIOSTEMI RCT 1,300 24-Month FU available TLF at 12 Months
TAGLIERI et al. Network Meta-Analysis 99,039 - TLF at 12 months and the longest FU available
BIOFLOW-V RCT 1,334 36-month FU available TLF at 12 Months
BIO-RESORT RCT 3,514 36-month FU available TVF at 12 Months
BIONYX RCT 2,488 36-month FU available TVF at 12 Months
BIOSCIENCE RCT 2,119 Completed, 60-month FU available TLF at 12 months

 

Taglieri et al. network meta-analysis

Orsiro - ranked as the best DES‡

99,039 patients in a network meta-analysis of 77 RCTs14

Orsiro is associated with a lower 1-year rate of TLF compared with Xience (OR (95% CI) 0.84 [0.71, 0.98], p=0.03) and Resolute§ (OR (95% CI) 0.81 [0.68, 0.95], p = 0.01).

Orsiro – the highest probability (70.8%) to rank as the best stent.‡

SUCRA – Surface Under the Cumulative Ranking Curve.
◊ In large RCTs, based on Taglieri et al. Meta-analysis, against currently used DES.
‡ Based on 1-year TLF SUCRA score, in comparison to Xience, Resolute and Nobori/BioMatrix, after a median follow-up period of 50 months.
§ Resolute Integrity and Resolute Onyx.
ψ The Nobori, BioMatrix, Cre8, Biofreedom and Cypher drug eluting stents are not available in the US.

BIOFLOW-V trial

Improving patient outcomes, year after year15

BIOFLOW-V (n = 1,334) FDA pivotal trial16,17,18,19,20
Significant differences in TLF observed at year 1 and 2 were maintained and further increased at year 3 (8.6% vs. 14.4%, p = 0.003), driven by significant differences in TV-MI (5.5% vs. 10.1%, p = 0.004) and Ischemia-driven TLR (3.4% vs. 6.9%, p = 0.008) that favor Orsiro over Xience.

TLF and components at 12, 24 and 36 Months

40%

lower TLF rate20 ф
(p=0.003)

46%

lower TV-MI rate20 ф
(p=0.004)

52%

lower Ischemia-driven TLR rate20 ф
(p=0.008)

Ischemia-driven TLR Landmark Analysis19

ST at 36 Months19

1. In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability, BIOTRONIK data on file; 2. As characterized with respect to strut thickness in Bangalore et al. Meta-analysis; 3. Based on investigator’s interpretation of BIOFLOW-V primary endpoint result; 4. BIOTRONIK data on file; 5. Per investigators’ interpretation of preclinical studies with Orsiro as mentioned in Cassese et al. J Thorac Dis 2018;10(2):688-692; 6. When compared to FDA approved Drug Eluting Stents. BIOTRONIK data on file; 7. Foin N et al. International journal of cardiology. 2014 Dec 20;177(3):800-8; 8. Stefanini GG et al. Coronary stents: novel developments. Heart. 2014 Jul 1;100(13):1051-61; 9. Low AF. Stent platform for procedural success: Introducing the Continuous Sinusoidal & Core Wire Technologies. Presented at: AsiaPCR; 22-24 January, 2015; Singapore, Singapore; 10. Tolentino A. Evolving DES Strategy: Biodegradable Polymer vs. Bioabsorbable Scaffold. Presented at: Cardiovascular Nurse/Technologist Symposium; June 17, 2016; New York, USA; 11. Secco G et al. Time-related changes in neointimal tissue coverage of a novel Sirolimus eluting stent: Serial observations with optical coherence tomography. Cardiovascular Revascularization Medicine 2016; 17(1): 38-43; 12. Buiten R et al. Outcomes in patients treated with thin-strut, very thin-strut, or ultrathin-strut drug-eluting stents in small coronary vessels - A prespecified analysis of the randomized BIO-RESORT trial. JAMA Cardiol. 2019. doi:10.1001/jamacardio.2019.1776: Clinical Trials. gov: NCT01674803; 13. BIOTRONIK data on file, as of January 2020; 14. Taglieri N et al. Target lesion failure with current drug-eluting stents: Evidence from a comprehensive network meta-analysis. JACC 2020 13(24):2868-78; 15. Compared to Xience in BIOFLOW-V, based on three consecutive years; 16. Kandzari D et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017. 390(10105):1843-1852; 17. Kandzari D, et al. BIOFLOW-V: A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions Science. Presentation at ESC 2017; 18. Kandzari D et al. Ultrathin bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents. JACC. 2018. 72(25):3287-97; 19. Kandzari, D et al. Ultrathin bioresorbable-polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents for coronary revascularization: 3-year outcomes from the randomized BIOFLOW V trial. JACC: Cardiovascular Interventions. 2020, doi: 10.1016/j. jcin.2020.02.019; 20. Kandzari D et al. D et al. Ultrathin bioresorbable-polymer sirolimus-eluting stents versus thin durable-polymer everolimus-eluting stents for coronary revascularization: 3-year outcomes from the randomized BIOFLOW V trial. JACC: Cardiovascular Interventions. 2020. Supplementary material.


Orsiro, Orsiro Mission, proBIO and BIOlute are trademarks or registered trademarks of the BIOTRONIK Group of Companies. Synergy, Promus and Taxus are trademarks or registered trademarks of the Boston Scientific Group of Companies. Resolute, Integrity, Resolute Onyx and Resolute Integrity are trademarks or registered trademarks of the Medtronic Group of Companies. Xience and Xience Sierra are trademarks or registered trademarks of the Abbott Group of Companies. Biofreedom and BioMatrix are trademarks or registered trademarks of the Biosensors International Group. Cre8 is a trademark or registered trademark of the Alvimedica Group of Companies. Nobori is a trademark or registered trademark of the Terumo Group of Companies. Cypher is a trademark or registered trademark of the Cardinal Health Group of Companies.