New Orsiro

Orsiro®

Key Product Features

Product Overview

Technical Data

Media

Key Product Features

Outstanding patient outcomes

One of the most studied DES*

Orsiro has an extensive clinical program with more than 55'000 patients enrolled and more than 68 studies started²

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Excellent deliverability

The Orsiro Stent System provides ultrathin stent struts without compromising radial strength, and a low crossing profile as a significant contributor to deliverability.

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Ultrathin 60μm struts

Thinner 60μm struts** make the difference

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References

* in large RCTs, based on Taglieri et al. Meta-analysis, against currently used DES; ² BIOTRONIK data on file, status January 2020;                 **nominal strut thickness for size ø 2.25 - 3.0mm, mean diameter 62 μm

Product Overview

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

TLF – Target Lesion Failure; TV-MI – Target Vessel Myocardial Infarction; TLR – Target Lesion Revascularization. § 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).


Long-term performance

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.

Excellent deliverability

Better push

Transmits up to 72% more force from hub to tip.14

Easier cross

Up to 79% less force needed to successfully cross demanding anatomies.14

Lower crossing profile

Up to 79% less force needed to successfully cross demanding anatomies.14

Ultrathin 60** μm 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 patients9, 10 

16%

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

‡ 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.


Strut thickness in perspective11

References

** nominal strut thickness for size ø 2.25 - 3.0mm, mean diameter 62 μm; 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. Foin et al. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol.2014 Dec 20;177(3):800-8; 8. 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; 9. 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; 10. 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; 11. Stefanini GG et al. Coronary stents: novel developments. Heart. 2014 Jul 1;100(13):1051-61; 12. Low AF. Stent platform for procedural success: Introducing the Continuous Sinusoidal & Core Wire Technologies. Presented at: AsiaPCR; 22-24 January, 2015; Singapore, Singapore; 13. Tolentino A. Evolving DES Strategy: Biodegradable Polymer vs. Bioabsorbable Scaffold. Presented at: Cardiovascular Nurse/Technologist_Symposium; June 17, 2016; New York, USA; 14. BIOTRONIK data on file.
Target Lesion Failure (TLF), Target Lesion Revascularization (TLR), Target Vessel Myocardial Infarction (TV-MI), Stent Thrombosis (ST).
Orsiro, proBIO and BIOlute are trademarks or registered trademarks of the BIOTRONIK Group of Companies.
Synergy and Promus are trademarks or registered trademarks of the Boston Scientific group of companies. Resolute and Resolute Onyx are trademarks or registered trademarks of the Medtronic group of companies. Xience, Xience Prime 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.

Technical Data

Indication

 
 

Orsiro is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST-elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of ≤ 36 mm.


Technical Data

Stent

 

Stent material

Cobalt chromium, L-605

Passive coating

proBIOTM (Amorphous Silicon Carbide)

Active coating

BIOluteTM bioabsorbable drug matrix consisting of sirolimus and polymer poly-l-lactide (PLLA)

Nominal drug dose

1.4 µg/mm²

   

Delivery system

Catheter type

Fast-exchange

Recommended guide catheter

5F (min. I.D.Δ ≥ 0.056”)

Guide wire diameter

0.014” (0.36 mm)

Usable catheter length

140 cm

Balloon material

Polymer

Coating (Distal shaft)

Hydrophilic coating

Marker bands

Two platinum-iridium markers

Proximal shaft diameter

2.0F

Distal shaft diameter

ø 2.25-3.5 mm: 2.7F; ø 4.0 mm: 3.0F

Nominal pressure (NP)

ø 2.25-2.75, 3.5-4.0 mm: 7 atm; ø 3.0 mm: 8 atm

Rated burst pressure (RBP)

16atm

ΔI.D. = Inner Diameter

 


Ordering Information

Stent

ø (mm)

Stent Length

(mm)

 

 

9

13

15

18

22

26

30

35

40

2.25

419101

419107

419113

419119

419125

419131

419137

 

 

2.5

419102

419108

419114

419120

419126

419132

419138

419144

419150

2.75

419103

419109

419115

419121

419127

419133

419139

419145

419151

3.0

419104

419110

419116

419122

419128

419134

419140

419146

419152

3.5

419105

419111

419117

419123

419129

419135

419141

419147

419153

4.0

419106

419112

419118

419124

419130

419136

419142

419148

419154

 
Media

Introducing Orsiro - now available in Canada




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