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The CURATIS Renal Stent System is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic atherosclerotic lesion (≤ 29 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0mm to 8.0 mm. Sub-optimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20 mmHg peak systolic or ≥ 10 mmHg mean translesional pressure gradient, flow-limiting dissection, or TIMI [Thrombolysis In Myocardial Infarction] flow < 3.
The CURATIS Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
| CURATIS Renal stent | |
| Available stent length (mm) | 10, 13, 15, 19, 20, 24 & 29 |
| Available stent diameter (mm) | 4.00 to 7.00 7.50-8.00 |
| Stent Material | A medical grade L605 Cobalt Chromium alloy |
| Rapid Exchange PTA Balloon Delivery System | |
| Balloon Delivery System | RX (Ø 0.014”) |
| Usable Shaft Length (cm) | 150 |
| Balloon Material | Polyn P® |
| Guidewire Compatibility | 0.014” |
| Shaft Diameter | 5 F |
| Sheath Compatibility | 5 F to 7F |
| Hydrophilic Coating | On the distal and proximal shaft of balloon delivery system |
| Balloon Inflation Pressure | Nominal Pressure (NP): 9 atm Rated Burst Pressure (RBP): 14 atm (for: Stent diameter 4.00 to 6.00mm) 13 atm (for: Stent diameter 6.50 to 8.00mm) |
