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Europe, Middle East, Africa / Product Areas / Interventional Cardiology/Radiology / Coronary Interventions / Orsiro™ Mission™ DES

Orsiro™ Mission™ DES

Delivering superiority1,a

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)
  • High Bleeding Risk (HBR)
  • One Month of Dual Antiplatelet Therapy (DAPT) in HBR Patients
  • Calcified Lesions (moderate/severe calcification)
  • Complex Lesions (B2/C)
  • 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 product image

Product Highlights

Push graph placeholder

The next level of deliverability2

1st in Push3, 1st in Track3, 1st in Cross3

Track graph placeholder

Ultrathin struts4

For early endothelialization5

Cross graph placeholder

Outstanding patient outcomes6,b

Proven superiority in STEMI up to 5 years1,b,c

Deliverability icon

The next level of deliverability2

Orsiro™ Mission™ DES transmits up to 96% more force from hub to tipd, requires 33% less force to follow the path to the lesiond, and 64% less force to crosse.

1st in Push3

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

Better Pushability

1st in Track3

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

Better Trackability

1st in Cross3

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

Better Crossability
Ultrathin struts icon

Ultrathin struts4

For early endothelialization.5

wider range of vessels
Orsiro-Thickness-Perspective

Outstanding patient outcomes6,b

Orsiro™ DES proves continued superiority in the first randomized controlled trial demonstrating superiority between two contemporary DES.12

Orsiro™ family of DES – One of the most studied DES 14,b,i

Better Trackability
Better Pushability

Clinical Highlights

BIOFLOW-V16

36% significantly lower TV-MI with Orsiro™

Comparison of Ultrathin Sirolimus-Eluting Bioresorbable Polymer with Thin Everolimus-Eluting Durable Polymer Stents.

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BIOSTEMI1

31% lower risk of TLF with Orsiro™

Investigator-initiated, prospective, multicentre, assessor-blinded, randomized (1:1), controlled. Superiority trial comparing Orsiro and Xience in STEMI patients undergoing primary PCI.

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BIOFLOW-DAPT17

Orsiro™ Mission™ DES showed safety and efficacy for short-DAPT

Prospective, multi-center, international, two-arm randomized controlled clinical study, including a total of 1,948 subjects.

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TAGLIERI NETWORK MA18

70.8% probability for Orsiro™ to rank as best stent

Network meta-analysis of randomized controlled trials comparing Orsiro™ and 9 other currently used drug-eluting stents.

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Product Overview



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) 36 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

Double Helix Stent Design
Nominal diameter (mm) 2.25 2.5 2.75 3 3.5 4
Strut thickness (µm) 60 = = = 80 =
Strut width (µm) 75 = = = 85 =
Amount of connectors 3 = = = 3 =
Amount of crowns at end 8 = = = 8 =

Maximal Expansion and Stent Strut Opening
Nominal diameter (mm) 2.25 2.5 2.75 3 3.5 4
Nominal outer diameter of the stent at NP (mm) 2.37 2.62 2.87 = = =
Maximal expansion diameter (mm) 4 = = = 5 =
Stent strut opening diameter at NP* (mm) 0.79 0.92 = = 1.06 1.25
Maximal diameter of expanded stent cell (mm) 3.59 = = = 4.42 =

*Mean of the largest possible opening diameter within a stent cell at NP

= symbol used to show repetition 

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 419104 419110 419116 419122 419128 419134 419140 419146 419152
3.5 419105 419111 419117 419123 419129 419135 419141 419147 419153
4 419106 419112 419118 419124 419130 419136 419142 419148 419154

IFU Link

Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions.

References:

*Indication as per IFU

  1. Data on file (n = 5), based on statistically significant differences on the bench for Pushability, Trackability, and Crossability compared to Xience Skypoint, superior to Xience in STEMI patients;
  2. Clinical data collected with Orsiro DES device within the Orsiro DES family clinical program;
  3. In comparison to Xience, based on TLF with Orsiro DES;
  4. In comparison to Resolute Onyx, data on file;
  5. In comparison to Synergy XD, data on file;
  6. Always refer to the Instructions for Use (IFU) for the Maximum Diameter for post-dilation applying in your country;
  7. Ø 2.25-3.0 mm strut thickness 60 μm, Ø 3.5-4.0 mm strut thickness 80 μm;
  8. 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,
  9. Clinical data collected with Orsiro Mission DES device within the Orsiro DES family clinical program;
  10. At 5-year in STEMI patients.

  1. Iglesias JF. et al, Long-term outcomes with biodegradable polymer sirolimus eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomized superiority trial, The Lancet, 2024;
  2. In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability and crossability, data on file;
  3. In comparison to Resolute Onyx, Xience Sierra and Synergy, data on file;
  4. As characterized with respect to strut thickness in Bangalore et al. Meta-analysis;
  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. Based on investigator’s interpretation of BIOFLOW-V endpoint results;
  7. Based on Kapoor A. et al., The road to the ideal stent: A review of stent design optimization methods, findings, and opportunities, Materials&Design, 2024;
  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. 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;
  12. Iglesias J 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. The Lancet. 2019 Sep 2;
  13. data on file, status February 2023;
  14. In large RCTs, based on Taglieri et al. Meta-analysis, against currently used DES;
  15. Based on TLF primary endpoint. Iglesias, JF. et al. Long-term outcomes with biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomized superiority trial, presented at TCT 2023;
  16. 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;
  17. Valgimigli M et al. Circulation 2023 Aug 25;
  18. Taglieri N et al. Target lesion failure with current drug-eluting stents evidence from a comprehensive network meta-analysis. JACC 2020.
Teleflex, the Teleflex logo, BIOlute, Orsiro, Orsiro Mission and ProBIO are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S and/or other countries. All other names are the trademarks or registered trademarks of their respective owners. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries. © 2025 Teleflex Incorporated. All rights reserved.