Vascular Intervention // Coronary
Cobalt Chromium Coronary Stent System
PRO-Kinetic Energy
Clinically proven results
Ultrathin struts
Exceptional deliverability
Clinically proven resultsNumerically, the lowest TVF* of 9.06% across FDA IDE studies from leading BMS competitors.1
*Target Vessel Failure rate as a composite of Cardiac Death, Myocardial Infarction (MI) and ischema-driven Target Vessel Revascularization.
Ultrathin strutsStruts of only 60 μm result in exceptional flexibility and deliverability of the stent in even the most challenging anatomy.6
Flexibility7
The lowest bending stiffness for outstanding flexibility.
Radial strength7
Double Helix stent design maintains sufficient radial strength with thin strut design and provides stability for optimal scaffolding and support.
Exceptional deliverability
Expect effortless deliverability from the stent delivery system featuring an Enhanced Force Transmission shaft and thinner materials for added pushability and trackability. anatomy.
Crossability7
Ultrathin struts and advanced crimping for a minimized crossing profile.
Pushability7
Exceptional pushability with Enhanced Force Transmission shaft.
PRO-Kinetic Energy
Indicated for improving coronary luminal diameter.**
Technical Data
| Stent | |
|---|---|
| Stent material | Cobalt chromium, L-605 |
| Passive coating | proBIO (Amorphous Silicon Carbide) |
| Strut thickness | ø 2.0 - 3.0 mm: 60 μm (0.0024”); ø 3.5 - 4.0 mm: 80 μm (0.0031”); ø 4.5 - 5.0 mm: 120 μm (0.0047”) |
| Delivery System | |
|---|---|
| Catheter type | Rapid exchange |
| Recommended guide catheter | 5F (min. I.D. 0.056”) |
| Lesion entry profile | 0.017” |
| Guide wire diameter | 0.014” |
| Usable catheter length | 140 cm |
| Balloon material | Semi-crystalline Co-Polymer material |
| Coating (distal shaft) | Hydrophilic coated |
| Marker bands | Two swaged platinum-iridium markers |
| Proximal shaft diameter | 2.0F |
| Distal shaft diameter | 2.5F: ø 2.0 - 3.5 mm; 2.8F: ø 4.0 - 5.0 mm |
| Nominal pressure (NP) | 9 atm |
| Rated burst pressure (RBP) | 16 atm (2.0 - 4.0 mm); 14 atm (4.5 - 5.0 mm) |
Compliance Chart
| Balloon diameter x length (mm) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ø 2.0 x 9-20 | ø 2.25 x 9-20 | ø 2.5 × 9-22 | ø 2.75 × 9-30 | ø 3.0 × 9-30 | ø 3.5 × 9-40 | ø 4.0 × 9-40 | ø 4.5 × 13-40a | ø 5.0 × 13-40a | |||||||||||
| Nominal Pressure (NP) | atm** ø(mm) | 9 2.00 | 9 2.25 | 9 2.50 | 9 2.75 | 9 3.00 | 9 3.50 | 9 4.00 | 9 4.50 | 9 5.00 | |||||||||
| Rated Burst Pressure(RBP) | atm** ø(mm) | 16 2.33 | 16 2.59 | 16 2.83 | 16 3.12 | 16 3.42 | 16 4.07 | 16 4.65 | 14 5.11 | 14 5.63 | |||||||||
| a22mm, 35mm stent lengths not available. **1 atm = 1.013 bar | |||||||||||||||||||
Ordering Information
Contact
1 Results from different trials are not directly comparable. Differences in outcomes may be the result of differences in protocol design, patient populations or other factors;
2 BIOTRONIK: US Food and Drug Administration, Center for Devices and Radiological Health. PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System, P160003; www.fda.gov (accessed 16.Nov.2016);
3 Medtronic: US Food and Drug Administration, Center for Devices and Radiological Health Driver Over-The Wire, Rapid Exchange and Multi-Exchange Coronary Stent System, P030009; www.fda.gov (accessed 16.Nov.2016);
4 Boston Scientific: US Food and Drug Administration, Center for Devices and Radiological Health, REBELTM Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), P130030; www.fda.gov (accessed 23.Nov.2016);
5 Abbott Vascular: US Food and Drug Administration, Center for Devices and Radiological Health. MULTI-LINK VISION OTW Coronary Stent System, P020047; www.fda.gov (accessed 16.Nov.2016); 3 (II);
6 Applicable for sizes Ø 2.0 - 3.0 mm;
7 Ø 3.0 mm diameter, when compared to key competitors. B IOTRONIK data on file.
Rebel is a registered trademark of Boston Scientific; Multi-Link 8 is a registered trademark of Abbott; Integrity is a
registered trademark of Medtronic.
**Indication as per IFU.