Choose then Conquer
DE Portfolio Mantra Video
See how Boston Scientific is committed to advancing science in the fight against PAD by boldly innovating with next-generation, drug-eluting technology.
Two head-to-head trials.
Zero doubt.
Bold is being the first company to conduct Level-1 head-to-head comparative effectiveness trials directly comparing drug-eluting technologies. And we did it twice.
Eluvia DES Clinical Trials ›
Ranger DCB Clinical Trials ›
DE Investment in Clinical Data
The best outcomes begin with our investment in the quality and quantity of evidence you demand.
Drug-Eluting Technologies
Eluvia™ Drug-Eluting Vascular Stent System
Eluvia DES is designed with sustained release to match the restenotic process of the SFA, and has demonstrated superior primary patency at 1-Year against bare metal stents in EMINENT2 and Zilver PTX in IMPERIAL3. Eluvia DES delivers superior results.
Ranger™ Drug-Coated Balloon
Ranger DCB is built on the physician preferred Sterling™ 0.014”/0.018" balloon platform4 with the lowest tip entry profile of any SFA DCB5 and backed by clinical results which demonstrate consistent near 90% patency at 1-Year6 and exceptional outcomes at 2 years7. Ranger DCB delivers like nothing else.
ELEGANCE PATIENT REGISTRY
Addressing inequities in the treatment of Peripheral Artery Disease
The ELEGANCE Registry is a post-market clinical study with aims to expand the body of clinical evidence on the outcomes of patients diagnosed with peripheral artery disease — particularly those who identify as female and people of color — after being treated with a Boston Scientific drug-eluting device.
An enrollment update was shared at VIVA 2022—read the details on the registry progress below.
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2. 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).
3. IMPERIAL Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against Cook Medical’s Zilver™ PTX™ Stent, single-blind, non-inferiority design; independent core lab adjudication. Superiority determined in a post hoc analysis that was specified prior to unblinding. 1-Year Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
4. DRG data, CY 2020, 0.018" PTA Balloons.
5. 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.
6. 88.4% K-M Primary Patency in the COMPARE Head-to-Head RCT. 1-Year Results published in the European Heart Journal. doi.org/10.1093/eurheartj/ehaa049. 89.8% K-M Primary Patency in the RANGER II SFA RCT.1-Year Results published in JACC:CI. doi.org/10.1016/j.jcin.2021.03.021.
7. RANGER II SFA RCT 2-Year Results presented by Ravish Sachar, MD. VIVA 2021. Highest 2- year primary patency based on 2-Year Kaplan-Meier estimates reported for Ranger II SFA, IN.PACT SFA, ILLUMENATE and LEVANT II including PTA arms.