Standing on evidence in SFA interventions
Eluvia and Ranger are defining a new standard in PAD endovascular intervention clinical evidence.
Enrolling over 10,000 patients globally in multiple head-to-head randomised controlled trials and real-world registries, Boston Scientific is giving physicians evidence-based tools to take the fight to PAD.
Both Ranger and Eluvia consistently demonstrate exceptional outcomes in complex lesions and patients in any trial at any time point in any geography.
RCTs that offer the most robust evidence of any DET portfolio
We have made bold investments in no fewer than six rigorously designed randomised controlled trials (RCTs) to demonstrate the safety, efficacy, and superiority of our drug-eluting technologies vs standards of care and competitive products. All six trials met their primary endpoint – robust evidence to give you confidence that you are making the very best choice for your patients.
Ranger DCB
Eluvia DES
RANGER II SFA RCT 2021
Highest ever primary patency vs PTA
COMPARE RCT 2020
90% primary patency with half PTX dose
Ranger SFA RCT 2018
Safety and Efficacy
SPORTS RCT 2023
ELUVIA VS. BMS VS. DCB
EMINENT RCT 2022
Superior primary patency vs BMS
IMPERIAL RCT 2021
Superior TLR vs Zilver PTX
Real-world evidence
We don’t stop at RCTs – we continue to invest in multiple studies and registries designed to challenge our drug-eluting technologies in high-risk patients with complex lesions – cases that reflect real-world practice at its very most demanding.
*These investigator-sponsored studies are supported or partially supported by grant funding from Boston Scientific. Boston Scientific is not responsible for the collection, analysis or reporting of these studies which remain the sole responsibility of the investigators. Information for the use in countries with applicable product registrations Muenster 2 years analysis only.
**supported by the Research Association for Lower Limb Artery Revascularization (LIBERAL) sponsored by the following companies: Boston Scientific Japan K.K., OrbusNeich Foundation, Terumo Corp., and Kaneka Medix Corporation. The funding companies played no role in the design of the study; selection of the enrolled patients; treatment strategy; revascularization procedures or equipment; or collection, analysis, or interpretation of the data.
*** no BSC funding support.
ꝉ First in human single-arm study.
Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.
References:
1. Ranger II SFA: Sachar R, Soga Y, Ansari MM, et al; RANGER II SFA Investigators. 1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon. JACC Cardiovasc Interv. 2021;14(10):1123–1133.
2. Eminent: Gouëffic Y, Torsello G, Zeller T, et al; EMINENT Investigators. Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial. Circulation. 2022;146(21):1564–1576.
3. Ranger SFA: Steiner S, Willfort-Ehringer A, Sievert H, et al; RANGER SFA Investigators. 12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment. JACC Cardiovasc Interv. 2018;11(10):934–941.
4. Compare: Steiner S, Schmidt A, Zeller T, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020;41(27):2541–2552.
5. Imperial: Müller-Hülsbeck S, Benko A, Soga Y, et al. Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021;44(3):368–375.
6. Elegance: Brodmann M. DET in complexities co-morbidities, and underserved patient populations. Presented at CIRSE 2022, Barcelona, Spain, 11 September 2022.
7. Randomised Controlled Trials: Brodmann M. Randomised Control Trial Data: The Pinnacle of Proof. Presented at LINC 2023, Leipzig, Germany, 6–9 June 2023.
8. Popcorn Type R: Imada K. POPCORN Type R. JET 2023, May 26, 2023, Tokyo.
9. Popcorn 2Y: Tanaka A. POPCORN 2Y Result. JET 2023, May 26, 2023, Tokyo.
10. Capsicum: Iida O, Takahara M, Soga Y, et al; CAPSICUM Investigators. 1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration. JACC Cardiovasc Interv. 2022 Mar 28;15(6):630–638. Iida LINC 2023.
11. Muenster 5yrs: Torsello G. LINC 2023; June 6, 2023; Leipzig, Germany.
12. Desafinado: Kum S, Ipema J, Huizing E, et al. Outcomes of the paclitaxel-eluting Eluvia stent for long femoropopliteal lesions in Asian patients with predominantly chronic limb-threatening ischemia. Vasc Med. 2021;26(3):267–272.
13. Regal: Lansik W. Real world all-comers data from the REGAL registry – 2-year results. Presented at LINC 2023.
14. Auckland: Holden, A. Single Centre Long-Term Experience with the Boston Scientific Eluvia DES in Femoro-popliteal Artery Occlusive Disease. Presented at LINC 2020.
15. Capricorn: Soga Y, JET 2023.
16. Prospect-Monster: Nakama, T. Second-generation low-dose drug-coated balloon vs high-dose drug-coated balloon for symptomatic femoropopliteal artery disease: The result from the PROSPECT-MONSTER study. Presented at LINC 2023.
17. K-ELUVIA: Ko YG. 2-year clinical outcome of the Eluvia drug-eluting stent for femoropopliteal lesions: A prospective multicenter K-ELUVIA registry. Presented at LINC 2023
18. Ranger China: Prospective, Non-randomized, Multicentre Clinical Study of the Boston Scientific Paclitaxel-Coated PTA Balloon Catheter (Ranger™ and Ranger™ SL (OTW) DCB) in China: NCT02944971 Zhong Chen, dr.,Beijing Anzehn hospital July 2023.
19. Ranger SFA Registry: Prospective Multicentre all-comer registry Lichtenberg M. CIRSE 2017, BSC Symposium Study is sponsored by Klinikum Arnsberg.
20. SPORTS: Tepe G. SPORTS. TCT 2023, October 24, 2023, San Francisco, CA.