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Full system

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,a – thinnest available in the US5

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

Low stent thrombosis (ST) at 5 years11

Thinner struts make the difference7

• Less disrupted flow
• Improved re-endothelialization

 

Strut thickness in perspective8
Orsiro Mission
BIOTRONIK

CoCr-SES 60 μma

Synergy XD
Boston Scientific

PtCr-EES, 74 μm

Resolute Onyx9,10
Medtronic

CoNi-ZES, 81 μm

Xience Family
Abbott

CoCr-EES, 81 μm

Outstanding patient outcomes12

ONE OF THE MOST STUDIED DESd

55000

 

55000

 

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 Completed 60-month FU available TLF at 12 Months
BIO-RESORT RCT 3,514 Completed 60-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 DES – the highest probability (70.8%) to rank as the best stent14,e

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

Orsiro DES 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 Resolutef (OR (95% CI) 0.81 [0.68, 0.95], p = 0.01).

BIOFLOW-V trial

Pushing the boundaries of performance with Orsiro DES15
BIOFLOW-V (n = 1,334) FDA pivotal trial15

TLF and components out to 5 years16,17,18
ST events out to 5 years16

TLF – Target Lesion Failure; TV-MI – Target Vessel Myocardial Infarction; TLR – Target Lesion Revascularization; ST – Stent Thrombosis. 

a Nominal strut thickness for size ø 2.25 - 3.0 mm, mean diameter 62 μm; b 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; c In comparison to Resolute Integrity, based on 5-year results of the BIO-Resort trial SV subgroup; d In large RCTs, based on Taglieri et al. Meta-analysis, against currently used DES; e Based on 1-year TLF SUCRA score, in comparison to Xience, Resolute and Nobori/BioMatrix, after a median follow-up period of 50 months14;  f Resolute Integrity and Resolute Onyx; g The Nobori, BioMatrix, Cre8, Biofreedom and Cypher drug eluting stents are not available in the US; h p-values for 60-m frequentist analysis of BIOFLOW-V16;  i In comparison to Xience, based on 60-m frequentist analysis of BIOFLOW-V16.

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. As characterized with respect to strut thickness in Bangalore 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; 5. When compared to FDA approved Drug Eluting Stents. BIOTRONIK data on file; 6. 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; 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. Ploumen etal. BIO-RESORT Small Vessels 5Y-EuroPCR2022; 12. Based on investigator’s interpretation of BIOFLOW-V primary endpoint result. Lancet. 2017 Oct 21; 390(10105):1843-1852; 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. In comparison to Xience, based on statistically significant lower TV-MI and late/very late definite/probable ST rates from the BIOFLOW-V trial through 5 years; 16. Kandzari D Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents for Coronary Revascularization: Final 5-year Outcomes from the Randomized BIOFLOW V Trial. Presented at CRT 2022; 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 in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Lancet. 2017 Oct 21; 390(10105):1843-1852.

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

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Specifications are subject to modification, revision and improvement.