Pulsar-18 T3

Vascular Intervention // Peripheral
Self-Expanding Stent System/0.018”/OTW
 
Pulsar®-18 T3

A unique combination of 3 technologies

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Tri-axial system with braided shaft
 
Low profile delivery system
 
Thin struts, low COF
 
 

Pulsar 18 T3


Easy to use, intuitive wheel-operated handle and one-handed deployment




 

Unique tri-axial shaft design on a 4F low-profile delivery system

Wheel-operated handle ergonomically designed


Easy-to-use handle


Tri-axial system with braided retractable shaft


Accurate stent deployment


The outer stabilizing shaft isolates the retractable shaft from friction caused by the introducer valve to ensure accurate stent deployment.


4F low profile - improved acute outcomes* vs. 6F3


Potential for safer, faster and simpler procedures than 6F


  • Clinically proven lower access site complication rates3
  • Shorter compression time3
  • 45% smaller puncture site than 6F1
  • No need for a closure device3
  • Potential for ambulatory treatment


*Less access site complications

 

Thin struts and low chronic outward force

140 μm thin struts - thinner than leading brands4


Thinner struts for lower chronic outward force (COF)5



Thinner struts and lower COF make a difference:*


  • Lower risk of restenosis2
  • Reduced vessel injury and inflammation2
  • Faster endothelialization6,7

*As demonstrated in pre-clinical studies


Vessel response on SE stent 1 mm oversizing showing neointimal hyperplasia at 90 days8*



Sufficient radial force for long term vessel support, even in calcified lesions




 

Clinically proven thin struts stent design


Pulsar stent outcomes at 12 months


Safety and efficacy at 12 months


Long-term outcomes in perspective


Pulsar stent outcomes at 24 and 36 months, highlighting long-term safety and efficacy.



Pulsar-18 T3

Indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0 mm and total lesion lengths up to 190 mm.*

Technical Data

Pulsar-18 T3 Stent
Catheter type
 OTW
Recommended guide wire
 0.018"
Stent material
 Nitinol
Strut thickness
 140 μm
Strut width
 85 μm - 90 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

Contact

contact

1. BIOTRONIK data on file;

2. Zhao HQ Late stent expansion and neointimal proliferation of oversized nitinol stents in
peripheral arteries. Cardiovasc. Interv. Radiol. 2009; 32(4); 720-6;

3. 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;

4. BIOTRONIK data on file. 6.0 mm diameters;

5. BIOTRONIK data on file. 6.0 mm diameters. Supera stent not possible to test due to its design and applied test method;

6. 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;

7. 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;

8. 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;

9. 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_10.1024/0301-1526/a000785;

10. 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;

11. BIOFLEX-I Pulsar 2018 Post Approval Clinical Report_Final_36m;

12. Lichtenberg M. et al PEACE I All-Comers Registry: Patency Evaluation After Implantation of the 4-French Pulsar-18 Self-Expanding Nitinol Stent in Femoropopliteal Lesions. J ENDOVASC THER. 2014;21:373–380, doi:10.1583/13-4637R.1;

13. Garcia LA et al. SUPERB Final 3-Year Outcomes Using Interwoven Nitinol Biometric Supera Stent. Catherization and Cardiovascular Interventions 2017; 89: 1259-1267;

14. Bosiers M. 4EVER 24 month results: long-term results of 4F Pulsar stent in femoropopliteal lesions. Presented at: CIRSE 2013; Barcelona, Spain;

15. Medtronic Complete SE SSED P110040 (September 19, 2013);

16. Bunte M et al. in STROLL Catheterization and Cardiovascular Interventions 2018; 92:106-114;

17. Osprey Misago P140002 (May 22, 2015);

18. Laird J et al. RESILIENT SFA nitinol stenting JET 2012;19:1-9;

19. Rocha-Singh et al. DURABILITY II Three-Year Follow-up. Catheterization and Cardiovascular Interventions 2015; 86:164-170;

20. SuperNOVA. US Food and Drug Administration, Center for Devices and Radiological Health, Innova™ Vascular Self-Expanding Stent System P140028.

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.;