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 μma (0.0024”); ø 3.50 - 4.0 mm: 80 μm (0.0031”)
Passive coating proBIOTM (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

 

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a ø 2.25 – 3.0 mm

Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical outcomes.

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

© 2022 BIOTRONIK AG – All rights reserved
Specifications are subject to modification, revision and improvement.