PRO-Kinetic Energy

Vascular Intervention // Coronary
Cobalt Chromium Coronary Stent System

PRO-Kinetic Energy

 




   Clinically proven results

   Ultrathin struts

   Exceptional deliverability

 

 

 

 

 

 


 

 

 

 

 

Clinically proven results

Numerically, 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 struts

Struts 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


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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);

4Boston 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);

5Abbott 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);

6Applicable for sizes Ø 2.0 - 3.0 mm;

7Ø 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.