Orsiro

Vascular Intervention // Coronary
Drug-Eluting Stent System
 
Orsiro®
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Outstanding patient outcomes
 
Highly deliverable
 
Ultrathin 60* μm struts

 

*ø 2.25 – 3.0 mm

 

Ultrathin struts§. Outstanding patient outcomes◊.

 

Outstanding patient outcomes

 

Improving patient outcomes, year after year*

 

BIOFLOW-V (n = 1,334) the FDA pivotal trial

 

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 Ischemiadriven TLR (3.4% vs. 6.9%, p = 0.008) that favor Orsiro over Xience.1,2,3

 

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.
ф vs. Xience, based on 36-m frequentist analysis.

 

Superiority in STEMI4

 

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.

 

 

Long-term safety

 

In the randomized, all-comers BIOSCIENCE trial (n= 2,119)5
Orsiro shows numerically equal or lower Stent Thrombosis (ST) in complex patients in comparison to Xience.

 

 

* Compared to Xience, BIOTRONIK data on file, based on the Rate Ratio of 0.59.
**BCI: Bayesian Credibility Interval.
¤ n= 1,300 newly enrolled STEMI patients including 407 patients from the BIOSCIENCE STEMI subgroup used as prior information.

 

Highly deliverable

 

Better push

 

Transmits up to 72% more force from hub to tip.13

 

 

Easier cross

 

Up to 79% less force needed to successfully cross demanding anatomies.13

 

 

Lower crossing profile

 

Improved acute performance – up to 7% lower crossing profile.13

 

 

 

Ultrathin 60 μm struts

 

Improved outcomes start in the acute phase

 

 

Thinner struts make the difference

 

Ultrathin vs. second generation DES in a large scale meta-analysis including more than 11,000 patients.8,9

 

 

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 &bt; 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.

 

 

 

 

Orsiro
Indicated for discrete de novo stenotic lesions and in-stent restenotic lesions.*

 

 

Technical Data

Technical Data

Compliance Chart

Compliance Chart

Ordering Information

Ordering Information
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Vascular Intervention

More about Orsiro

Coronary Drug-Eluting Stent

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1. Kandzari D et al. Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimuseluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017 Oct 21; 390(10105):1843-1852; 2. 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; 3. Kandzari D et al. J Am Coll Cardiol. Cardiovasc Interven. 2020, doi: 10.1016/j.jcin.2020.02.019. 4. 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; 5. 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; 6. Foin et al. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol.2014 Dec 20;177(3):800-8; 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. Bangalore S et al. Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease: metaanalysis of randomized trials. Circulation. 2018 Nov 13;138(20):2216-26; 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 Jul. 24: 2216-2226; 10. Stefanini GG et al. Coronary stents: novel developments. Heart. 2014 Jul 1;100(13):1051-61; 11. Low AF. Stent platform for procedural success: Introducing the Continuous Sinusoidal & Core Wire Technologies. Presented at: AsiaPCR; 22-24 January, 2015; Singapore, Singapore; 12. Tolentino A. Evolving DES Strategy: Biodegradable Polymer vs. Bioabsorbable Scaffold. Presented at: Cardiovascular Nurse/TechnologistSymposium; June 17, 2016; New York, USA; 13. BIOTRONIK data on file.

*Indication as per IFU.

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.