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. PTX-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. BIOTRONIK 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. PTX 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. PTX-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. BIOTRONIK data on file; 9. BIOTRONIK data on file, 8.0 mm stent diameter; 10. Endovascular Today – Europe Buyer´s Guide 2019, Balloon-Expandable Stents; 11. BIOTRONIK data on file, Design Verification and Validation Result; 12. BIOTRONIK data on file; 13. Binkert C. BIOLUX P-III Real-world experience with a PTX-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 DCB 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 DCB in the treatment of femoropopliteal occlusive disease. Vascular 2018;26:3–11

Oscar, Passeo, Pulsar, Dynetic, Fortress, Astron, Dynamic, and SafeGuard are trademarks or registered trademarks of the BIOTRONIK Group of Companies. The Passeo®-18 Lux® DCB with its Lux® coating is part of the Lux® family of PTX-coated balloons from BIOTRONIK. Carnelian is a trademark or registered trademark of Tokai Medical Products, Inc., manufactured by Tokai Medical Products, Inc. and distributed by BIOTRONIK in selected countries. Fortress is manufactured by Contract Medical International GmbH and distributed by BIOTRONIK in selected countries.

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