Drug-eluting therapies

A bold step forward.

Boston Scientific is committed to advancing science in the fight against PAD by boldly innovating with next-generation, drug-eluting technology. Backed by Level-1 Randomized Controlled Trials, our proven exceptional results put the power of choice in the hands of those who make it happen. Together, we can save more limbs and help more people walk without pain.

Read the Full Boston Scientific Response to FDA Update About Use of Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease

IMPERIAL RTC- ~90% Patency at 1 year -COMPARE RCT

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.

EMINENT Clinical Trial COMPARE Clinical Trial

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 Stent

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.

Learn more about Eluvia DES

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.

Learn more about Ranger DCB

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Addressing inequities in the treatment of Peripheral Artery Disease

ELEGANCE Patient Registry

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.

Learn more about the ELEGANCE Registry

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Standing together.

Restenosis replacement program

The Bold Step Program is a statement of our confidence in the efficacy of our drug-eluting products. The program offers an Eluvia DES or Ranger DCB at no additional charge if a patient requires reintervention within the first year due to restenosis.

Ordering and reimbursement

Get downloads for ordering information and reimbursement coding guides for our drug-eluting technologies.

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Eluvia indications, safety, and warnings

Ranger indications, safety, and warnings

1. 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. 92.1% K-M Primary Patency in the IMPERIAL Head-to-Head RCT. 1-Year Results published in The Lancet. https:/ /doi.org/10.1016/50140-6736(18}32262-1.
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.