Self-Expanding Stent System/0.018”/OTW
Pulsar-18 T3
Indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after Percutaneous Transluminal Angioplasty (PTA), e.g. residual stenosis and dissection.*
Technical Data
| 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:20 - 200 mm |
| Shaft | 4F, hydrophobic coating, tri-axial |
| Usable length | 90 cm and 135 cm |
Ordering Information
| Stent ø (mm) | Catheter length 90 cm (Stent length mm) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 20** | 30 | 40 | 60 | 80 | 100 | 120 | 150 | 170 | 200 | |||||
| 4.0 (4F) | 430437 | 430438 | 430439 | 430440 | 430441 | 430442 | 430443 | 430444 | 430445 | 430446 | ||||
| 5.0 (4F) | 430447 | 430448 | 430449 | 430450 | 430451 | 430452 | 430453 | 430454 | 430455 | 430456 | ||||
| 6.0 (4F) | 430457 | 430458 | 430459 | 430460 | 430461 | 430462 | 430463 | 430464 | 430465 | 430466 | ||||
| 7.0 (4F) | 430467 | 430468 | 430469 | 430470 | 430471 | 430472 | 430473 | 430474 | 430475 | 430476 | ||||
| Stent ø (mm) | Catheter length 135 cm (Stent length mm) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 20** | 30 | 40 | 60 | 80 | 100 | 120 | 150 | 170 | 200 | |||||
| 4.0 (4F) | 430477 | 430478 | 430479 | 430480 | 430481 | 430482 | 430483 | 430484 | 430485 | 430486 | ||||
| 5.0 (4F) | 430487 | 430488 | 430489 | 430490 | 430491 | 430492 | 430493 | 430494 | 430495 | 430496 | ||||
| 6.0 (4F) | 430497 | 430498 | 430499 | 430500 | 430501 | 430502 | 430503 | 430504 | 430505 | 430506 | ||||
| 7.0 (4F) | 430507 | 430508 | 430509 | 430510 | 430511 | 430512 | 430513 | 430514 | 430515 | 430516 | ||||
| **8 weeks pre-order only | ||||||||||||||
Contact
1 BIOTRONIK data on file. 6.0 mm diameters;
2 BIOTRONIK data on file. 6.0 mm diameters. Supera stent not possible to test due to its design and applied test method;
3 Zhao HQ Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc. Interv. Radiol. 2009; 32(4); 720-6;
4 Koskinas C. Role of endothelial shear stress in stent restenosis and thrombosis: pathophysiologic mechanisms and implications for clinical translation. JACC 2012 10;59(15):1337-49;
5 Koppara T. Thrombogenicity and early vascular healing response in metallic biodegradable polymer-based and fully bioabsorbable drug-eluting stents. Circ Cardiovasc Interv. 2015 8(6):e002427;
6 Funovics M. Correlation between chronic outward force (COF) and neointimal hyperplasia in self-expanding nitinol stents in swine in clinically relevant oversizing ranges. Presented at: LINC, Jan 26, 2017; Leipzig, Germany;
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 BIOTRONIK data on file;
9 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 ; 54(4):433-9;
10 Lichtenberg et al. Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions - the BIOFLEX PEACE All-Comers Registry.Vasa (2019), 1-9. doi_10.10240301-1526a000785;
11 Supera IFU, EL2100430 (2016-03-23);
12 Bosiers M. 4EVER 24 month results: long-term results of 4F Pulsar stent in femoropopliteal lesions. Presented at: CIRSE 2013; Barcelona, Spain;
13 Bunte M et al. in STROLL Catheterization and Cardiovascular Interventions 2018; 92:106-114;
14 Laird J et al. RESILIENT SFA nitinol stenting. JET 2012;19:1-9;
15 Dake M et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Am Heart Assoc 133.15 (2016): 1472-1483. doi: 10.1161/CIRCULATIONAHA.115.016900;
16 Rocha-Singh et al. DURABILITY II Three-Year Follow-up. Catheterization and Cardiovascular Interventions 2015; 86:164-170.
Leading competitors have been selected based on the PV Stent Revenue Market Shares EU, 2017 and PV Revenue Market Shares APAC 2015; (Source: Millennium Research Group Inc.). Latest SFA self expanding stents for each manufacturer; Zilver and Zilver Flex are trademarks or registered trademarks of Cook Medical Technologies or its affiliates. Innova is a trademark or registered trademark of Boston Scientific or its affiliates. Everflex and Entrust are trademarks or registered trademarks of Medtronic or its affiliates. Lifestent is a trademark or registered trademark of C. R. Bard or its affiliates. Supera is a trademark or registered trademark of the Abbott Group of Companies. S.M.A.R.T. Control is a trademark or registered trademark of Cardinal Health or its affiliates.
*Indication as per IFU.
Pulsar and proBIO are trademarks or registered trademarks of the BIOTRONIK Group of Companies.