More evidence.
The only drug-eluting technologies for use in the superficial femoral artery (SFA) backed by 5 RCTs, and studies that will exceed 10,000 patients1,6.
More confidence.
Consistent outcomes in RCTs and real world studies give you the confidence to choose EluviaTM and RangerTM DET.7-8
More successful outcomes.
Fewer repeat procedures with EluviaTM and RangerTM compared to alternative
devices.9-10
FDA and CIRSE support the use of paclitaxel for SFA treatment
Latest DET data releases and updates
At LINC 2023, several clinical updates were shared covering our DET portfolio, including 4-year data for the Ranger II SFA RCT and several registries.
The new long-term clinical data consistently demonstrates exceptional outcomes in SFA lesions for both Ranger and Eluvia DET.
Restenosis after SFA Interventions remains highly prevalent
Bare metal stents (BMS) and percutaneous transluminal angioplasty (PTA) are still widely used despite being associated with high restenosis rates.11
Since the first use of PTA nearly 60 years ago, SFA disease management remains inconsistent. BMS and PTA are still widely used even though meta-analysis of randomised controlled trials reveal that they are associated with high restenosis rates.11-12
New-generation endovascular approaches, however, such as drug coated devices, have helped to reduce restenosis rates.13-14
Paclitaxel devices are effective and safe
- Paclitaxel is effective
- Paclitaxel is safe
Paclitaxel DET help reduce restenosis, resulting in better outcomes for patients vs BMS or POBA¹³⁻¹⁴
The EMINENT RCT combined with network meta-analysis of RCTs conclude that DES and DCBs respectively, result in greater primary patency versus non-drug devices.13-14
All-cause mortality rates for paclitaxel-coated vs uncoated products¹⁰⁻¹⁴
Katsanos - 1
Eluvia and Ranger are defining a new standard of care in SFA treatment with robust clinical data¹⁻⁶
Click below to read more about the relevant clinical trial:
Ranger DCB
Eluvia DES
Eluvia demonstrates consistent outcomes in complex lesions in both real world evidence and RCTs
| 12 month primary patency | |
| CAPSICUM registry | 87.1%15 |
| Imperial RCT | 91%16 |
Drug-Eluting Technologies
References
- Sachar R 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;10:1123–1133.
- Gouëffic Y, et al. 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;146:1564–1576.
- Steiner S, et al. 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment. JACC Cardiovasc Interv. 2018;11:934–941.
- Steiner S, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020;41:2541–2552.
- Müller-Hülsbeck S, 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;44:368–375.
- Marianne Brodmann, CIRSE 2022 Symposium: DET in complexities co-morbidities, and underserved patient populations.
- Torsello G, Real World Evidence, LINC 2023
- Iida O, Real World Data from Japan, LINC 2023
- Müller-Hülsbeck S, 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;44:368–375.
- Sachar R 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;10:1123–1133.
- Kasapis C, et al. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials. Eur Heart J. 2009;30(1):44–55
- Aboyans V, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018;39:763–816.
- Ullah W, et al. Safety and efficacy of drug-coated balloon for peripheral artery revascularization-A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2022;99(4):1319–1326.
- Gouëffic Y, et al. 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;146:1564–1576.
- Osamu Iida et al. 1-Year Outcomes of Fluoropolymer-Based Drug-Eluting Stent in Femoropopliteal Practice: Predictors of Restenosis and Aneurysmal Degeneration, JACC: Cardiovascular Interventions, Vol 15, Issue 6, 2022, 630-638
- Gray WA, Lancet. 2018 Sep 24. pii: S)!$)-6736(18)32262-1
- EMINENT Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against commercially-available Self-Expanding Bare Nitinol Stents, single-blind, superiority design; independent core lab adjudication. Primary Endpoint: 1-Year Binary Primary Patency rate of 83.2% in the Eluvia arm vs. 74.3% in the Bare-Metal Stenting arm (p-value = 0.0077).
- Boston Scientific Data on File. Ranger Catheter Competitive Testing Report, 92517674. Measurements taken from 6 x 120 devices for Ranger DCB, Lutonix™ 035 DCB, IN.PACT Admiral DCB and Stellarex™ 035 DCB. Lutonix 018 DCB measurements taken from 6 x 150 devices.
- RANGER II SFA RCT 2-Year Results presented by Ravish Sachar, MD. VIVA 2021.
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.