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.
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.
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.
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