REFERENCES:

1. per IFU: Indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography. 2. Tepe G. Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry. Cardiovasc Intervent Radiol. 2021;44:207-217; 3. Data on file, IIB Bench test report; 4. Koskinas KC et al. Role of endothelial shear stress in stent restenosis and thrombosis, Pathophysiologic mechanisms and implications for clinical translation. JACC 2012;59:1337–49; 5. Foin N et al. Impact of stent strut design in metallic stents and biodegradable scaffolds. Internat J Cardiol. 2014 Dec 20;177(3):800–808; 6. Scheinert D. Paclitaxel Releasing Balloon in femoropopliteal lesions using BTHC excipient: 12-month results from the BIOLUX P-I randomized trial. JEVT. 2015; 22(1): 14-21; 7. Zeller et al. Paclitaxel-Coated Balloon in Infrapopliteal arteries 12-month results from the BIOLUX P-II randomized trial. J Am Coll Cardiol Intv. 2015; 8: 1614-22; 8. Data on file, IIB Bench test report: Investigation of Peripheral Drug Coated Balloons Drug Loss in Introducer Sheath; 9. Data on file, 8.0 mm stent diameter; 10. Endovascular Today – Europe Buyer´s Guide 2019, Balloon-Expandable Stents; 11. Data on file, Design Verification and Validation Result; 12. Ddata on file; 13. Binkert C. BIOLUX P-III Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 24-month results of the BIOLUX P-III All Comers Registry in Superficial Femoral Arteries. Presented at: CIRSE 2018. Lisbon, Portugal; 14. 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. FTLR and Primary Patency for stent only group; 15. Deloose K. BIOLUX 4EVER: Combining Passeo-18 Lux DCB and Pulsar-18 BMS: 24-month results of full cohort. Presented at: LINC 2018. Leipzig, Germany; 16. Mwipatayi P. DEBAS Study: First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease. Vascular 2018;26:3–11.

*Excluding central circulatory system and neurovasculature; indicated as per IFU.

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