Indication

 
 
  Orsiro Mission DES is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length ≤ 40 mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm including the following patient and lesion subsets:
  Acute Coronary Syndrome (ACS)
ST-Elevation Myocardial Infarction (STEMI)
Diabetes Mellitus (DM)
Complex Lesions (B2/C)
High Bleeding Risk (HBR)
Long Lesions (LL) (e.g. ≥ 20 mm)
Small Vessels (SV) (e.g. ≤ 2.75 mm)
Multi-Vessel Disease (MVD)
Male/Female
Old Patients (e.g. > 65 y)

Orsiro Mission DES is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length ≤ 40 mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm including the following patient and lesion subsets:

Acute Coronary Syndrome (ACS)
ST-Elevation Myocardial Infarction (STEMI)
Diabetes Mellitus (DM)
Complex Lesions (B2/C)
High Bleeding Risk (HBR)

Long Lesions (LL) (e.g. ≥ 20 mm)
Small Vessels (SV) (e.g. ≤ 2.75 mm)
Multi-Vessel Disease (MVD)
Male/Female
Old Patients (e.g. > 65 y)

Technical data

 
STENT
Stent Material Cobalt chromium, L-605
Strut thickness ø 2.25 - 3.0 mm: 60 μm (0.0024”); ø 3.50 - 4.0 mm: 80 μm (0.0031”)
Passive coating proBIO (Amorphous Silicon Carbide)
Active coating BIOlute bioabsorbable Poly-L-Lactide (PLLA) eluting a limus drug
Drug dose 1.4 μg/mm2
Delivery system
Catheter type Rapid exchange
Recommended guide catheter 5F (min. I.D. 0.056”)
Guide wire diameter 0.014”
Usable catheter length 140 cm
Balloon material Semi crystalline polymer material
Coating (Distal shaft) Hydrophilic
Coating (Proximal shaft) Hydrophobic
Marker bands Two swaged platinum-iridium markers
Lesion entry profile 0.017”
Distal shaft diameter 2.7F: ø 2.25 - 3.0 mm; 2.9F: ø 3.5 - 4.0 mm
Proximal shaft diameter 2.0F
Nominal pressure (NP) 10 atm
Rated burst pressure (RBP) 16 atm

 

Storage  
Use Before Date (UBD) 24 months
Temperature Between 15°C (59°F) and 25°C (77°F), short term ​​​​​​​excursions between 10°C (50°F) and 40°C (104°F) are allowed

Ordering Information

Stent ø (mm) Catheter length 140 cm Stent length (MM)
  9 13 15 18 22 26 30 35 40
2.25 419101 419107 419113 419119 419125 419131 419137 419143 419149
2.50 419102 419108 419114 419120 419126 419132 419138 419144 419150
2.75 419103 419109 419115 419121 419127 419133 419139 419145 419151
3.00 419104 419110 419116 419122 419128 419134 419140 419146 419152
3.50 419105 419111 419117 419123 419129 419135 419141 419147 419153
4.00 419106 419112 419118 419124 419130 419136 419142 419148 419154

 

Orsiro Mission is indicated for complex patients and lesions*

Contact Us

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.
¶ vs. Xience, based on TLF, in the BIOSTEMI trial.
◊ p-values for 36-m frequentist analysis (see supplemental material).
* 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.