Orsiro DES | Orsiro

Orsiro®DES

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Outstanding patient Outcomes

Improving Patient Outcomes, Year After Year*

BIOFLOW-V (n = 1,334) the FDA pivotal trial1,2,3,4,5

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 rateф
(p=0.003)

46%

lower TV-MI rateф
(p=0.004)

52%

lower Ischemia-driven TLR rateф
(p=0.008)

Long-term safety

In the randomized, all-comers BIOSCIENCE trial (n= 2,119)6

Orsiro shows numerically equal or lower Stent Thrombosis (ST) in complex patients in comparison to Xience.

Superiority in STEMI10

BIOSTEMI (n=1,300) is the first RCT demonstrating superiority between two contemporary DES

Orsiro is superior to Xience in STEMI patients undergoing primary PCI with respect to Target Lesion Failure (TLF) rate at 12 months.

4%

Orsiro

6%

Orsiro

Rate Ratio (95% BCI**): 0.59, (0.37-0.94) Posterior probability of Superiority: 98.6%

Bayesian ITT Population#

Highly deliverable

Better push

Transmits up to 72% more force from hub to tip.7

Easier cross

Up to 79% less force needed to successfully cross demanding anatomies.7

Lower crossing profile

Improved acute performance – up to 7% lower crossing profile.7

Ultrathin 60µm struts

Improved outcomes start in the early phase
Thinner struts make the difference

Ultrathin vs. second generation DES in a large scale meta-analysis including more than 11,000 patients.11,12

16%

Relative risk reduction in TLF at 12 months
RR (95% CI) 0.84 [0.72, 0.99]

Strut thickness in perspective13
OrsiroBIOTRONIK

CoCr-SES, 60 μm*

60 μm*

SynergyBoston Scientific

PtCr-EES, 74 μm

74 μm

UltimasterTerumo

CoCr-SES, 80 μm

80 μm

Resolute Onyx14,15Medtronic

CoNi-ZES, 81 μm

81 μm

Xience FamilyAbbott

CoCr-EEs, 81 μm

81 μm

PromusBoston Scientific

PtCr-EES, 81 μm

81 μm

BioMatrixBiosensors

316L-BES, 120 μm

120 μm

* ø 2.25 – 3.0 mm

§As characterized with respect to strut thickness in Bangalore et al. Meta-analysis.
◊Based on investigator’s interpretation of BIOFLOW-V primary endpoint results.
*Compared to Xience, based on three consecutive years.
¤p-values for 36-m frequentist analysis (see supplemental material).
ф vs. Xience, based on 36-m frequentist analysis (see supplemental material).
**BCI: Bayesian Credibility Interval.
# n= 1,300 newly enrolled STEMI patients including 407 patients from the BIOSCIENCE STEMI subgroup used as prior information.
​​​​​​​¶ Compared to Xience, BIOTRONIK data on file based on the Rate Ratio of 0.59.
‡ Driven by peri-procedural MI events (<48 hours). In-hospital rate may include events > 48 hours.
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.

1. 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 Oct 21; 390(10105):1843-1852; 2. 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; 3. Kandzari D et al. Ultrathin bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents. Journal of the American College of Cardiology. 2018 Dec 17;72(25):3287-97; 4. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020, doi: 10.1016/j. jcin.2020.02.019; 5. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020 Supplemental Material; 6. 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; 7. BIOTRONIK data on file.  8. Foin et al. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol.2014 Dec 20;177(3):800-8; 9. 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; 10. Iglesias JF et al. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial; Lancet, September, 2019; 11. Bangalore S et al. Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease: meta-analysis of randomized trials. Circulation. 2018 Nov 13;138(20):2216-26; 12. Bangalore S, et al. Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease: meta-analysis of randomized trials. Circulation. 2018 Jul. 24: 2216-2226; 13. Stefanini GG et al. Coronary stents: novel developments. Heart. 2014 Jul 1;100(13):1051-61; 14. Low AF. Stent platform for procedural success: Introducing the Continuous Sinusoidal & Core Wire Technologies. Presented at: AsiaPCR; 22-24 January, 2015; Singapore, Singapore; 15. Tolentino A. Evolving DES Strategy: Biodegradable Polymer vs. Bioabsorbable Scaffold. Presented at: Cardiovascular Nurse/TechnologistSymposium; June 17, 2016; New York, USA;

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 is a trademark or registered trademark of the BIOTRONIK Group of Companies.

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Specifications are subject to modification, revision and improvement.