CURATIS Cobalt Chromium Renal & Biliary Stent is a balloon expandable L605 cobalt chromium alloy stent pre-mounted onto a rapid exchange (RX) delivery catheter, which can be deployed by inflating balloon. Upon balloon inflation, the stent achieves a cylindrical shape, it is a permanent implant.
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
|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®|
|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)