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Orsiro®Mission
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)
Product Highlights
The next level of deliverability²
1st in Push3, 1st in Track3, 1st in Cross3
Ultrathin struts⁴
For early endothelialization5
Outstanding patient outcomes⁶ᵇ
Proven superiority in STEMI up to 5 years1,b,c
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.
Ultrathin struts4
For early endothelialization5
Outstanding patient outcomes6,b
Orsiro DES proves continued superiority in the first randomized controlled trial demonstrating superiority between two contemporary DES12.
Orsiro family of DES – One of the most studied DES14,b,i
Continued superiority in STEMI at 5 years15,b
In the BIOSTEMI trial, Orsiro DES is proven to be safe and effective at short- and long-term follow-up with 31% significantly less Target Lesion Failure (TLF) at 5-year in STEMI patients15,b
Product Overview
Orsiro Mission
Bioabsorbable coating
Ultrathin 60 µmᶜ struts
Passive coating
Enhanced force transmission
Dual-coating
Ergonomic hub
Flexible shaft
Deep embedding
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 |
| Double Helix Stent Design | ||||||
|---|---|---|---|---|---|---|
| Nominal diameter (mm) | 2.25 | 2.5 | 2.75 | 3.0 | 3.5 | 4.0 |
| Strut thickness (μm) | 60 | = | = | = | 80 | = |
| Strut width (μm) | 75 | = | = | = | 85 | = |
| Amount of connectors | 3 | = | = | = | = | = |
| Amount of crowns at end | 8 | = | = | = | = | = |
| Maximal Expansion and Stent Strut Opening | ||||||
|---|---|---|---|---|---|---|
| Nominal diameter (mm) | 2.25 | 2.5 | 2.75 | 3.0 | 3.5 | 4.0 |
| Nominal outer diameter of the stent at NP (mm) | 2.37 | 2.62 | 2.87 | 3.12 | 3.66 | 4.16 |
| Maximal expansion diameter (mm) | 4.0 | = | = | = | 5.0 | = |
| 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
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. BIOTRONIK 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; b. Clinical data collected with Orsiro DES device within the Orsiro DES family clinical program; c. In comparison to Xience, based on TLF with Orsiro DES; d. In comparison to Resolute Onyx, BIOTRONIK data on file; e. In comparison to Synergy XD, BIOTRONIK data on file; f. Always refer to the Instructions for Use (IFU) for the Maximum Diameter for post-dilation applying in your country; g. Ø 2.25-3.0 mm strut thickness 60 µm, Ø 3.5-4.0 mm strut thickness 80 µm; h. 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, i. Clinical data collected with Orsiro Mission DES device within the Orsiro DES family clinical program; j. 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, BIOTRONIK data on file; 3. In comparison to Resolute Onyx, Xience Sierra and Synergy, BIOTRONIK 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. 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; 13. BIOTRONIK 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.
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.