ELUVIA™

Drug-Eluting Vascular Stent System

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Expert panel discussion about IMPERIAL, the first head-to-head DES SFA Trial
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Hear William Gray, MD review the IMPERIAL Trial results.
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The Challenge
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The Solution
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The Heritage
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The Breakthrough
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The Data
Hear in-depth commentary on IMPERIAL, the first head-to-head DES SFA Trial, including key insights and perspectives on how the data will impact treatment of PAD patients.
Hear William Gray, MD review the IMPERIAL Trial results.
Hear what physicians have to say about the challenges of treating the SFA and how drug-eluting vascuar stents may help improve patient outcomes.
Physicians talk about the importance of drug-eluting stents in complex lesions and how the Eluvia Drug-Eluting Stent is designed to deliver controlled, localized, low-dose amorphous paclitaxel to target lesions.
See how over a decade of research helped Eluvia engineers develop the first drug-eluting stent for the SFA designed to sustain drug release when restenosis is most likely.
Physicians discuss the tuned paclitaxel elution profile of the Eluvia Drug-Eluting Stent and how the stent has demonstrated unprecedented efficacy data in patients with peripheral artery disease (PAD).
See what physicians are saying about the unprecedented clinical outcomes for the Eluvia Drug-Eluting Stent, including two-year primary patency and TLR rates.

The Eluvia Drug-Eluting Stent System showed SUPERIOR results in the first head-to-head DES SFA Trial.


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. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).

Product Details

24-Month Primary Patency Results

Eluvia demonstrated the highest ever 2-year primary patency1
1. Highest two-year primary patency based on 24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomization for Zilver  PTX RCT.
* Intention to treat. Kaplan-Meier estimate with standard errors. Primary patency defined as duplex ultrasound PSVR ≤2.4, in the absence of clinically-driven target lesion revascularization or bypass of the target lesion, as assessed by the DUS core lab.

24-Month Safety Results*

  • 85.8% of Eluvia patients were free from Major Adverse Events at 24 months (vs. 79.9% of Zilver PTX patients)
  • All-cause mortality for Eluvia was 7.1% (21/295) vs. 8.3% (12/145) for Zilver PTX (p=0.6649)
IMPERIAL 24-month safety results table
* Intention to treat. Clinical Events Committee-adjudicated adverse events included major adverse events (MAE), all deaths, and stent thrombosis. MAEs defined as all causes of death through 1 month, target limb major amputation through 24 months, and target lesion revascularization through 24 months.
  

Eluvia™ Drug-Eluting Vascular Stent System UPN and GTIN Codes

Description UPN GTIN
Eluvia 6 mm x 40 mm x 130 cm H74939294600410 08714729876571
Eluvia 6 mm x 60 mm x 130 cm H74939294600610 08714729876588
Eluvia 6 mm x 80 mm x 130 cm H74939294600810 08714729876595
Eluvia 6 mm x 100 mm x 130 cm H74939294601010 08714729876601
Eluvia 6 mm x 120 mm x 130 cm H74939294601210 08714729876618
Eluvia 7 mm x 40 mm x 130 cm H74939294700410 08714729876694
Eluvia 7 mm x 60 mm x 130 cm H74939294700610 08714729876700
Eluvia 7 mm x 80 mm x 130 cm H74939294700810 08714729876717
Eluvia 7 mm x 100 mm x 130 cm H74939294701010 08714729876724
Eluvia 7 mm x 120 mm x 130 cm H74939294701210 08714729876731

Reimbursement

As Eluvia is a new and novel technology, Boston Scientific believes that currently available C-Codes do not accurately describe it. However, the closest applicable C-Code to report the use of Eluvia is C1874, defined as “Stent, coated/covered, with delivery system." Note: Boston Scientific Corporation is not responsible for correct use of codes on submitted claims; this information does not constitute reimbursement or legal advice.
Clinical Programs

Clinical Programs

Unprecedented clinical outcomes in the SFA.

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Sustained Drug Release

Sustained Drug Release

Delivers paclitaxel when restenosis is most likely to occur.

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Product Design

Product Design

Built on the proven InnovaTM vascular stent platform.

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