Overexpansion Diameters*
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) High Bleeding Risk (HBR) One month of Dual Antiplatelet Therapy (DAPT) in HBR Patients Calcified Lesions (moderate/severe calcifications) 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 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) | 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 |
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 |