a. 99.3% resorbed at 12 months (markers are not resorbable), based on clinical data; b. More clinical studies including larger number of patients reporting clinical outcomes with longer follow-up time than BeGraft Coronary Stent Graft System; c. Compared to Jostent Graftmaster.

1.Based on statistically significant differences on the bench tests for Pushability, Trackability and Crossability compared to Xience Skypoint, BIOTRONIK data on file (n=5), Superior to Xience in STEMI patients, Iglesias JF. et al, Long-term outcomes with biodegradable polymer sirolimus eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomized superiority trial, The Lancet, 2024; 2. BIOTRONIK data on file; 3. Haude M. et al., the Lancet eClinicalMedicine 2023;59: 101940; 4. Haude, M. et al., EuroIntervention 2023;19:1-1 published online May 2023; 5. Seguchi M et al. OCTAnalysis 12M, presented at ESC 2023; 6. In comparison to Xience Sierra, Resolute Onyx and Synergy for bench tests on pushability, trackability, and crossability, BIOTRONIK data on file; 7. As characterized with respect to strut thickness in Bangalore et al. Meta-analysis; 8. Based on investigator’s interpretation of BIOFLOW-V primary endpoint result; 9. BIOTRONIK data on file, Benchtest data: Freesolve in comparison to BIOTRONIK Orsiro Mission and Abbott Xience Sierra; 10. Based on pre-clinical data, Seguchi, M et al, EuroIntervention 2023;18-online publish-ahead-of-print January 2023; 11. BIOTRONIK data on file, in comparison to predecessor device; 12. Based on intravascular OCT analysis of the BIOMAG-I trial presented by Dr. M. Seguchi at ESC 2023; 13. Tölg R et al. Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry EuroIntervention. 2014; 10(5). 591 -599; 14. Hehrlein C et al. Twelve-month results of a Paclitaxel Releasing Balloon in Patients Presenting with In-stent Restenosis First-in-Man (PEPPER) trial. Cardiovascular Revascularization Medicine. 2012; 17 (5): 260-264; 15. Kufner S, Joner M, Schneider S et al. Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents. JACC Cardiovasc Interv. 2017; 10(13). 1332 -1340; 16. Jensen C et al. Angiographic and clinical performance of a paclitaxel-coated balloon compared to a second-generation sirolimus-eluting stent in patients with in-stent restenosis: the BIOLUX randomised controlled trial. EuroIntervention. 2018; 14: 1096-1103; 17. Nguyen V.P.T et al. Comparison of clinical outcomes of two different types of paclitaxel-coated balloons for treatment of patients with coronary in-stent restenosis. Heart and Vessels. 2019. 1-9. doi: 10.1007/s00380-019-01388; 18. Assadi-Schmidt A et al. SeQuent Please vs. Pantera Lux drug coated balloon angioplasty in real life: Results from the Düsseldorf DCB registry, Int J Cardiol. 2016. doi: 11.1016/j.ijcard.2016.12.022; 19. Vos NS et al. Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study. EuroIntervention. 2014; 10(5). 584 -590; 20. Vos N S et al. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction (The REVELATION Randomized Trial). JACC: Cardiovascular Interventions. 2019; 1-9, doi:10.1016/j.jcin.2019.04.016; 21. Worthley S, Hendriks R, Worthley M et al. Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-months results of the multicenter BIOLUX-I study. Cardiovasc Revasc. Med. 2015; 16(7). 413 -417; 22. Jim MH et al. Six month angiographic result of supplementary paclitaxel-eluting balloon deployment to treat side branch ostium narrowing (SARPEDON). Int J Cardiol. 2015; 187:594 -597; 23. Roncalli J et al. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). J INVASIVE CARDIOL. 2019;31(4):94-100; 24. García-Touchard A, Goicolea J, Sabaté M et al. A randomised trial of paclitaxel-eluting balloon after bare metal stent implantation vs. bare metal stent in ST-elevation myocardial infarction (the PEBSI study). EuroIntervention. 2017; 12(13). 1587 -1594; 25. Radke PW et al. Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipients. EuroIntervention. 2011 Oct; 7(6): 730-7; 26. Hernandez-Enriquez M, et al. Outcomes after use of covered stents to treat coronary artery perforations. Comparison of old and new-generation covered stents. J Interv Cardiol. 2018; 1-7; 27. Nagaraja V , Schwarz K et al. Outcomes of patients who undergo percutaneous coronary intervention with covered stents for coronary perforation: A systematic review and pooled analysis of data. Catheter Cardiovasc Interv. 2019; 1–7. DOI: 10.1002/ccd.28646; 28. Birkemeyer R , Olivecrona G.K, Hellig F et al. Sealing of coronary perforations with a second-generation covered stent graft - Results from the PAST-PERF registry. Cardiovascular Revascularization Medicine. 2020; doi: 10.1016/j.carrev.2020.10.012; 29. Hernandez-Enriquez et al. Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus registry. Catheter Cardiovasc Interv. 2020; doi: 10.1002/ccd.29328; 30. Kandzari DE, Birkemeyer R. PK Papyrus covered stent: Device description and early experience for the treatment of coronary artery perforations. Catheter Cardiovasc Interv. 2019;1–5. doi.org/10.1002/ccd.28306; 31. Kandzari D.E, Sarao R.C. and Waksman R. Clinical experience of the PK Papyrus covered stent in patients with coronary artery perforations: Results from a multi-center humanitarian device exemption survey, Cardiovascular Revascularization Medicine. 2022. doi: 10.1016/j.carrev.2022.04.009; 32. Wańha W, Januszek R, Kołodziejczak M, Kuźma Ł, Tajstra M, Figatowski T et al. Procedural and 1-year outcomes following large vessel coronary artery perforation treated by covered stents implantation: Multicentre CRACK registry. PLoS ONE. 2021; 16(5): e0249698. doi: 10.1371/journal.pone.0249698; 33. Bossard, M., Maria Cioffi G., et al. “Burying” covered coronary stents under drug-eluting stents: A novel approach to ensure long-term stent patency. Cardiology Journal, 2023, 30(2), 196-198. https://doi.org/10.5603/CJ.a2022.0116; 34. Harnek J, James SK, Lagerqvist BO. et al. Very long-term outcome of coronary covered stents: a report from the SCAAR registry. EuroIntervention. 2019; 14: 1660-1667. doi: 10.4244/EIJ-D-18-00855; 35. Jurado-Roman A et al. Clinical outcomes after implantation of polyurethane-covered cobalt-chromium stents. Insights from the Papyrus-Spain registry. Cardiovascular Revascularization Medicine 2020 Aug; S1553-8389(20)30486-3. doi: 10.1016/j.carrev.2020.08.017. Online ahead of print; 36. Kufner S et al. Outcome after new generation single-layer polytetrafluoroethylene-covered stent implantation for the treatment of coronary artery perforation. Catheter Cardiovasc Interv. 2018; 1-9. DOI: 10.1002/ccd.27979; 37. Voll F, Koch T, Tölg R, Lenz T, Schroeter M, Lenders G, Hokken R, Cassese S, Xhepa E, Schunkert H, Kastrati A, Kufner S. Clinical safety and efficacy of new-generation single-layer polytetrafluorethylene covered coronary stents. Cardiovasc Revasc Med.2023:1–7; 38. Azzalini, L., Poletti, E., Ayoub, M., Ojeda, S., Zivelonghi, C., La Manna, A., Bellini, B., Lostalo, A., Luque, A., Venuti, G., Montorfano, M., Agostoni, P., Pan, M., Carlino, M., & Mashayekhi, K. Coronary artery perforation during chronic total occlusion percutaneous coronary intervention: Epidemiology, mechanisms, management, and outcomes. EuroIntervention. 2019. https://doi.org/10.4244/EIJ-D-19-00282.

CAUTION— Freesolve is an Investigational device. Limited by the United States law to investigational use. Clinical data collected with the Orsiro DES and/or Orsiro Mission DES device within the Orsiro family clinical program. The Pantera® Lux® DCB with its Lux® coating is part of the Lux® family of Paclitaxel-coated balloons from BIOTRONIK. Orsiro, Orsiro Mission, Freesolve, Pantera, Lux and PK Papyrus are trademarks or registered trademarks of the BIOTRONIK Group of Companies.

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