Vascular Intervention // Peripheral
Self-Expanding Stent System/0.018''/OTW
Pulsar-18
140 μm thin struts
4F low profile
Clinically proven
140 μm thin struts - thinner than the leading brands1
Thinner struts for low Chronic Outward Force (COF)2
Thinner struts and lower COF make a difference:*
- Lower risk of restenosis3
- Reduced vessel injury and inflammation4
- Faster endothelialization5
*As demonstrated in pre-clinical studies
1 mm stent oversizing at 90 days6
Clinically proven
Long term safety and efficacy (12 month data)
** FTLR - Freedom from Target Lesion Revascularization;
† PP - Primary Patency; ††A.L.L. - Average Lesion Length
Sufficient radial force for a long term vessel support,
even in calcified lesions
Exceptional clinical outcomes (12 month data)
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.
*Bail out group
Stent designed for SFA*
Multi-directional flexibility to conform to the natural vessel movement.
*Superficial Femoral Artery
Elongation
Low axial stiffness for high flexibility16
Bending
Peak-to-valley design and S-articulating connecting bars provide multi-directional flexibility and avoid fish scaling inmobile vessel architecture.17
4F Low Profile - Improved acute outcomes vs. 6F7
Potential for safer, faster and simpler procedures than 6F
- Clinically proven lower access site complication rates7
- Shorter compression time7
- 45% smaller puncture site area than 6F18
- No need for a closure device
Stent deployment
One-handed stent release handle, ergonomically designed for a comfortable and stable handling.
Pulsar-18
Indicated for use in patients with atherosclerotic disease of the femoral and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.*
Technical Data
| Pulsar-18 Stent | |
|---|---|
| Catheter type | OTW |
| Recommended guide wire | 0.018" |
| Stent material | Nitinol |
| Strut thickness | 140 μm |
| Strut width | 85 μm |
| Stent coating | proBIO (amorphous silicon carbide) |
| Stent markers | 6 gold markers each end |
| Sizes | ø 4.0 - 7.0 mm; L: 204 - 200 mm |
| Proximal shaft | 3.6 F, hydrophobic coating |
| Usable length | 90 and 135 cm |
Ordering Information
| 4.0 (4F) | 377456 | 377457 | 377458 | 377459 | 377460 | 366808 | 366809 | 366810 | 366811 | 366812 | ||||
| 5.0 (4F) | 377461 | 377462 | 377463 | 377464 | 377465 | 366813 | 366814 | 366815 | 366816 | 366817 | ||||
| 6.0 (4F) | 377466 | 377467 | 377468 | 377469 | 377470 | 366818 | 366819 | 366820 | 366821 | 366822 | ||||
| 7.0 (4F) | 377471 | 377472 | 377473 | 377474 | 377475 | 366823 | 366824 | 366825 | 366826 | 366827 | ||||
| 4.0 (4F) | 377476 | 377477 | 377478 | 377479 | 377480 | 366828 | 366829 | 366830 | 366831 | 366832 | ||||
| 5.0 (4F) | 377481 | 377482 | 377483 | 377484 | 377485 | 366833 | 366834 | 366835 | 366836 | 366837 | ||||
| 6.0 (4F) | 377486 | 377487 | 377488 | 377489 | 377490 | 366838 | 366839 | 366840 | 366841 | 366842 | ||||
| 7.0 (4F) | 377491 | 377492 | 377493 | 377494 | 377495 | 366843 | 366844 | 366845 | 366846 | 366847 | ||||
Contact
1 6.0 mm diameters. BIOTRONIK data on file;
2 6.0 mm diameters. Supera stent not possible to test due to its design and applied test method. BIOTRONIK data on file;
3 As demonstrated in pre-clinical studies: Zhao HQ Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc. Interv. Radiol. 2009 Jul; 32(4); 720-6;
4 As demonstrated in pre-clinical studies: Zhao HQ Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc. Interv. Radiol. 2009 Jul; 32(4); 720-6;
5 As demonstrated in pre-clinical studies: Konstantinos C. Role of endothelial shear stress in stent restenosis and thrombosis. JACC 2012; Koppara et al. Circ Cardiovasc. Interv 2015; 8: e002427; Soucy N. Strut tissue coverage and endothelial cell coverage: a comparison between bare metal stent platforms and platinum chromium stents with and without everolimus-eluting coating. EuroIntervention 2010;6:630-637;
6 Funovic M. Presented at LINC 2017; Astron Pulsar results can be used to illustrate the impact of over sizing on the vessel for Pulsar-18 stent due to the similarity in the Astron Pulsar and Pulsar-18 stent materials and designs;
7 Bosiers M, et al. 4-French -compatible endovascular material is safe & effective in the treatment of femoropopliteal occlusive disease: Results of the 4EVER Trial. ENDOVASC THER 2013; 20: 746-756;
8 Lichtenberg M. Superficial Femoral Artery TASC D registry: 12-month effectiveness analysis of the Pulsar-18 SE nitinol stent in patients with critical limb ischemia. J Cardiovasc Surg (Torino). 2013 Aug; 54(4):433-9;
9 Nolte-Ernsting C. BIOFLEX Peace 12-month results. Presented at CIRSE 2017;
10 Nolte-Ernsting C. BIOFLEX Peace 12-month results. Presented at CIRSE 2017;
11 Laird JR. Nitinol stent implantation versus balloon angioplasty for lesions in the Superficial Femoral Artery and Proximal Popliteal Artery. 12-month Results From the RESILIENT randomized trial (stent group). Circ Cardiovasc Interv. 2010; 3(3):267-76;
12 Supera SSED. US Food and Drug Administration, Center for Devices and Radiological Health. Supera® Peripheral Stent System P120020;
13 SuperNOVA. US Food and Drug Administration, Center for Devices and Radiological Health, Innova™ Vascular Self-Expanding Stent System P140028;
14 Dake M. Paclitaxel-Eluting Stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease. 12-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011; 4:495-504;
15 Bosiers M. Nitinol stent implantation in long Superficial Femoral Artery Lesions: 12-month results of the DURABILITY I Study. J ENDOVASC THER 2009; 16:261–269;
16 BIOTRONIK data on file;
17 BIOTRONIK data on file;
18 BIOTRONIK data on file.
Leading competitors have been selected based on the PV Stent Revenue Market Shares EU, 2017 and PV Revenue Market Shares APAC 2015; (Source: Milennium Research Group Inc.). Latest SFA self expanding stents for each manufacturer; Supera is a registered trademark of the Abbott Group of Companies; Lifestent is a registered trademark of C.R. Bard; Zilver is a registered trademark of Cook Medical; EverFlex and Entrust are registered trademarks of the Medtronic Group of Companies; Innova is a registered trademark of Boston Scientific.
*Indication as per IFU.