Case courtesy of Drs. Luis Mariano Palena and Marco Manzi.
Positive results even for long and occluded lesions in a high risk population
12-m FTLR
TASC D4
All-comers registry shows sustained results in a real world population
24-m FTLR BIOFLEX PEACE10 (stent only)
Chronic Outward Force (COF) is the force exerted on the vessel wall by a self-expanding stent to achieve its present diameter.11 Thinner struts, which have lower COF, result in a lower risk of restenosis, reduced vessel injury and inflammation and faster endothelialization.8,12,13
Lower risk of restenosis8
Reduced vessel injury and inflammation12
Faster endothelialization13
The first tri-axial, 4F thin-strut stent system for the treatment of lower limb peripheral arterial disease.
1. BIOFLEX-I SSED, BIOTRONIK data on file; 2. Bosiers M. et al. 4-French–compatible endovascular material is safe & effective in the treatment of femoropopliteal occlusive disease: Results of the 4EVER Trial. J ENDOVASC THER 2013; 20:746-756; 3. 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; 4. 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. 2013; 54:433-9; 5. Lichtenberg et al. Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions. Clinical Medicine Insights: Cardiology 2014:8(S2) 37–42 doi: 10.4137/CMC.S15224; 6. Evaluation of Market Acceptance 162091, BIOTRONIK data on file; 7. Accuracy of Stent Placement Design Verification and Validation 145265, BIOTRONIK data on file; 8. Zhao HQ Late stent expansion and neointimal proliferation of oversized nitinol stents in peripheral arteries. Cardiovasc. Interv. Radiol. 2009; 32(4); 720-6; 9. Bosiers M 4EVER 24m: long-term results of 4F Pulsar stent. Presented at: Cirse, 2013. Barcelona,Spain; 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. Freeman JW, et al. A link between stent radial forces and vascular wall remodeling: the discovery of an optimal stent radial force for minimal vessel restenosis. Connect Tissue Res. 2010 Aug; 54(4): 314-26; 12. 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; 13. 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; 14. BIOTRONIK data on file. 6.0 mm diameters. Supera stent not possible to test due to its design and applied test method.