Orsiro® Mission DES

Even better deliverability for the outstanding Orsiro DES1

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Full System

The next level of deliverability1

The next level of deliverability1

1st in Push3
Transmitting up to 57% more force from hub to tip.

Proven deliverability on the bench and in a real-world user evaluation of over 1,000 implantations:4

Proven deliverability on the bench and in a real-world user evaluation of over 1,000 implantations:4

1st in Track3
Up to 30% less force needed to follow the path to the lesion.
1st in Cross3
Up to 75% less force needed to successfully cross demanding anatomies.

Lesion crossing
with low friction,
reliable performance”

Dr. Mathias Brandt,
Paracelsus Medical University,
Salzburg, Austria

Ultrathin struts5

Ultrathin struts5

For early endothelialization

When a unique design translates into clinical benefits

Long-term safety

Low definite Stent Thrombosis (ST) out to 5 years

BIOSCIENCE, all-comers RCT (n= 2,119)10

Strut thickness in perspective6

OrsiroBIOTRONIK

CoCr-SES, 60 μm*

SynergyBoston Scientific

PtCr-EES, 74 μm

UltimasterTerumo

CoCr-SES, 80 μm

Resolute Onyx8,9Medtronic

CoNi-ZES, 81 μm

Xience FamilyAbbott

CoCr-EEs, 81 μm

PromusBoston Scientific

PtCr-EES, 81 μm

BioMatrixBiosensors

316L-BES, 120 μm

* ø 2.25 – 3.0 mm

Outstanding patient outcomes11

One of the most studied DES§
More than 55,000 patients enrolled and more than 68 Studies startedφ
BIOFLOW-V, FDA pivotal trial (n = 1,334)12, 13, 14, 15

Orsiro Mission is indicated for complex patients and lesions, including:*

ACS

STEMI

DM

HBR

B2C

SV

MVD

BIOSTEMI (n=1,300)

Continued Superiority in STEMI at 2 years.¶16

5.1%

Orsiro

8.1%

XIENCE

Target Lesion Failure (TLF) rate at 2 years.

Rate Ratio (95% BCI**): 0.58 (0.40-0.84) Posterior probability of Superiority: 99.8%

Bayesian ITT Population¤

BIO-RESORT Small Vessels (n=1,506)

Target Lesion Revascularization (TLR) rate
at 3 yrs.17

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.
§ in large RCTs, based on Taglieri et al. Meta-analysis, against currently used DES.
φ BIOTRONIK data on file, status January 2020.
◊ p-values for 36-m frequentist analysis (see supplemental material).
¶ vs. Xience, based on TLF, in the BIOSTEMI trial.
* As per IFU: ACS – Acute Coronary Syndrome; STEMI – ST-Elevation Myocardial Infarction; DM – Diabetes Mellitus.
HBR – High Bleeding Risk; B2C – Complex Lesions; SV – Small Vessels; MVD – Multi-Vessel Disease.
** BCI: Bayesian Credibility Interval.
¤ n= 1,300 newly enrolled STEMI patients including 407 patients from the BIOSCIENCE STEMI subgroup used as prior information.
‡ Based on a Rate Ratio of 0.58.

1. In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability, BIOTRONIK data on file; 2. Per investigators’ interpretation of preclinical studies with Orsiro as mentioned in Cassese et al. J Thorac Dis 2018;10(2):688-692; 3. BIOTRONIK data on file; 4. Evaluation of Market Acceptance, BIOTRONIK data on file; 5. As characterized with respect to strut thickness in Bangalore et al. Meta-analysis; 6. Stefanini GG et al. Coronary stents: novel developments. Heart. 2014 Jul 1;100(13):1051-61; 7. 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 17.1 (2016): 38-43; 8. Low AF. Stent platform for procedural success: Introducing the Continuous Sinusoidal & Core Wire Technologies. Presented at: AsiaPCR; 22-24 January, 2015; Singapore, Singapore; 9. Tolentino A. Evolving DES Strategy: Biodegradable Polymer vs. Bioabsorbable Scaffold. Presented at: Cardiovascular Nurse/Technologist Symposium; June 17, 2016; New York, USA; 10. Pilgrim T et al. 5-year outcomes of the BIOSCIENCE randomised trial. Supplementary appendix; Lancet 2018; published online Aug 28. http://dx.doi.org/10.1016/ S0140-6736(18)31715-X; 11. Based on investigator’s interpretation of BIOFLOW-V primary endpoint result; 12. 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 E SC 2017; 13. Kandzari D et al. Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents: Journal of American College of Cardiology (2018), doi: https //doi.org/10.1 016/j.jac c.2018. 09.019; 14. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020, doi: 10.1016/ j.jcin.2020.02.019; 15. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020. Supplemental Material; 16. Pilgrim et al. Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial. J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011; 17. 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. Published online May 21, 2019. doi:10.1001/jamacardio.2019.1776; ClinicalTrials.gov: NCT01674803. 

Synergy and Promus are trademarks or registered trademarks of the Boston Scientific Group of Companies. Resolute, Resolute Onyx and 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. Ultimaster is a trademark or registered trademark of the Terumo Group of Companies. BioMatrix is a trademark or registered trademark of the Biosensors International Group.

Orsiro, Orsiro Mission, proBIO and BIOlute are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

Disclaimer
Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical outcomes.

© 2022 BIOTRONIK AG – All rights reserved.
Specifications are subject to modification, revision and improvement.