Orsiro®Mission

    Even better deliverability for the outstanding Orsiro DES

    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)

    Category

    Vascular Intervention Coronary Drug-Eluting Stent System

    Product Highlights

    The next level of deliverability¹

    1st in Push, Track and Cross4

    Ultrathin struts²

    For early endothelialization5

    Outstanding patient outcomes³

    Proven Superiority in STEMI6

    The next level of deliverability¹

    Orsiro Mission DES transmits up to 96% more force from hub to tipa, requires 33% less force to follow the path to the lesiona, and 64% less force to crossb. 

    1st in Push⁴

    Transmitting up to 96% more force from hub to tip.

    1st in Track⁴

    Up to 33% less force needed to follow the path to the lesion.

    1st in Cross⁴

    Up to 64% less force needed to successfully cross demanding anatomies.
     

    Ultrathin struts²

    For early endothelialization5 

    Outstanding patient outcomes³

    Orsiro DES proves continued superiority in the first randomized controlled trial demonstrating superiority between two contemporary DES6. 

    Continued Superiority in STEMI at 2 yearsf6

    In the BIOSTEMI trial, Orsiro is superior to Xience in STEMI patients with respect to the primary endpoint of Target Lesion Failure (TLF) at 24 months. 

    Pushing the boundaries of safety performance with Orsirog

    In the 5-Year results of the FDA pivotal trial, BIOFLOW-V, Orsiro ultrathin-strut DES showed significantly less target vessel myocardial infarction events compared to Xience DP-EES.12

    Extensive Clinical Program of the Orsiro DES Familyj13

    Clinical Highlights

    Product Overview

    Orsiro Mission

    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)    		 Stent Length
    (mm)
      9 13 15 18 22 26 30 35 40
    2.25 419101 419107 419113 419119 419125 419131 419137 419143 419149
    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

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    References

    a. In comparison to Resolute Onyx, BIOTRONIK data on file; b. In comparison to Synergy XD, BIOTRONIK data on file; c. Ø2.25-3.0mm; d. 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; e. Bayesian Credible Interval; f. In comparison to Xience, based on TLF, in the BIOSTEMI trial at 2 years; g. 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; h. p-values for 60-month frequentist analysis; i In comparison to Xience, based on BIOFLOW-V 5-year results; j. Orsiro and Orsiro Mission DES; k. All-comers patients, BIO-RESORT 5 year outcomes; l. Based on 1-year TLF SUCRA (Surface Under the Cumulative Ranking Curve), Taglieri Network Meta-Analysis; m. In comparison to Xience, based on a Rate Ratio of 0.58, in the BIOSTEMI trial at 2 years. 

    1. In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability, BIOTRONIK data on file; 2. As characterized with respect to strut thickness in Bangalore et al. Meta-analysis; 3. Based on investigator’s interpretation of BIOFLOW-V primary endpoint result; 4. BIOTRONIK data on file; 5. Per investigators’ interpretation in Secco et al. Imaging data serial observations. Secco GG 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; 6. 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; 7. Stefanini GG et al. Coronary stents: novel developments. Heart. 2014 Jul 1;100(13):1051-61; 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. 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; 11. Iglesias JF, et al. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI) The Lancet. 2019 Oct 5;394(10205):1243-53; 12. Kandzari D et al. 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, Submitted manuscript to JACC, 2022: NCT02389946; 13. BIOTRONIK data on file, status February 2023; 14. Per investigators’ interpretation of preclinical studies with Orsiro as mentioned in Cassese et al. J Thorac Dis 2018;10(2):688-692; 15. E.Ploumen, BIO-RESORT 5 year outcomes and diabetic subgroup, TCT 2021; 16. 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. 

    Clinical data collected with the Orsiro DES device within the Orsiro family clinical program 

    Orsiro, Orsiro Mission, proBIO and BIOlute are trademarks or registered trademarks of the BIOTRONIK Group of Companies. All other trademarks are the property of their respective owners.