The Safety of Paclitaxel in Treating Peripheral Artery Disease

At Boston Scientific patient safety is our top priority. We are dedicated to helping physicians provide the best care possible for their patients. Recently, the U.S. Food and Drug Administration (FDA) provided new guidance about how physicians should consider the safety and benefits of paclitaxel devices for the treatment of people with peripheral artery disease (PAD).
 
Boston Scientific is partnering with physicians to ensure the Eluvia™ Drug-Eluting Vascular Stent (DES) System is accessible to appropriate patients living with PAD, consistent with the FDA’s recommendations.
 
Patients who have been implanted with the Eluvia stent should continue routine check-ups with their doctor. Patients should also ensure all medication prescribed by their doctor, such as blood thinners or statins, is taken as directed. Routine consultations with physicians on lifestyle modifications such as regular exercise and quitting smoking are important for patients with PAD to consider as they can have a positive impact on overall health.
 
Information about safety of the Eluvia stent is below and we encourage any patient with questions about treatment for their condition to speak with their healthcare provider.

 

The Eluvia Drug-Eluting Vascular Stent System

Our portfolio of approved coronary stents have been used for nearly 20 years.
The composition of the Eluvia stent is more like our portfolio of FDA-approved coronary stents – which have been used for nearly 20 years – based on its low drug dose, similar drug release mechanism and localized distribution of delivered drug.1-5
The five-year meta-analysis of approximately 2,800 patients in our TAXUS clinical trials demonstrated no difference in long term mortality.
The five-year meta-analysis of approximately 2,800 patients in our TAXUS clinical trials demonstrated no difference in long-term mortality with the paclitaxel-eluting TAXUS coronary stent compared to bare metal stents.2
We monitor the safety of the Eluvia stent and all the stents in our full portfolio.
As part of our commitment to safety and quality in all of our products, we monitor the safety of the Eluvia stent and our full portfolio of coronary stents through rigorous internal quality controls, as well as in our clinical trials through independent Clinical Events Committees.
We will continue the collection of long-term clinical data of more than 2,000 patents enrolled in out global trials of Eluvia.
We will continue our collection of long-term clinical data through follow-up of the nearly 2,000 patients enrolled in our global trials of Eluvia, as well as our robust, post-market surveillance process, and our stringent documentation of adverse events, all of which will add to the Boston Scientific body of clinical evidence supporting our paclitaxel-eluting devices to ensure that patients have access to safe and effective treatment options.
  

Lowest Amount of Paclitaxel 

The Eluvia stent has only 1/3 of the total drug dose compared to a competitor's peripheral drug-coated stent. The drug dose density is also approximately 18x lower.6,7

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The only peripheral stent approved by the FDA that has a polymer.

A Unique Mechanism for Delivery

The only peripheral stent approved by the FDA that has a polymer, which controls how and when the drug is released. The polymer matrix – studied in more than 100,000 patients in clinical trials and implanted in more than 20 million vessels – plays a critical role in coating integrity and stability and further enhances the safety of Eluvia.8,9

A Controlled Distribution of Paclitaxel

The low-dose drug on the Eluvia stent is released in a controlled manner – initially at the time of implantation and then sustained through a gradual release over the course of several months to prevent re-narrowing of the artery. 

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Learn more about device safety information

Safety Information about Boston Scientific Devices

Patient safety is our priority and our constant focus. Read more about how we monitor the safety of all of our devices.

Learn more about PAD

Peripheral Artery Disease

PAD is a cardiovascular disease in which narrowed arteries reduce blood flow to the limbs. Read more about the causes of PAD, risk factors and treatment options available.

Still Have Questions?

For more information on the Eluvia Stent, please contact 
Boston Scientific customer service at 1-888-272-1001.

  
  1. Data on file at Boston Scientific.
  2. Stone GW, Ellis SG, Colombo A, et al. Long-term safety and efficacy of paclitaxel-eluting stents final 5-year analysis from the TAXUS Clinical Trial Program. JACC Cardiovasc Interv. 2011;4(5):530-542.
  3. Ormiston JA, Charles O, Mann T, et al. Final 5-year results of the TAXUS ATLAS, TAXUS ATLAS Small Vessel, and TAXUS ATLAS Long Lesion clinical trials of the TAXUS Liberte paclitaxel-eluting stent in de-novo coronary artery lesions. Coron Artery Dis. 2013;24(1):61-68.
  4. Kereiakes DJ, Cannon LA, Dauber I, et al. Long-term follow-up of the platinum chromium TAXUS Element (ION) stent: The PERSEUS Workhorse and Small Vessel trial five-year results. Catheter Cardiovasc Interv. 2015;86(6):994-1001.
  5. Yamaji K, Raber L, Zanchin T, et al. Ten-year clinical outcomes of first-generation drug-eluting stents: the Sirolimus-Eluting vs. Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) VERY LATE trial. Eur Heart J. 2016;37(45):3386-3395.
  6. Data from Eluvia, Zilver PTX, Lutonix, Stellarex and IN.PACT DFUs.
  7. Data on file at Boston Scientific.
  8. Data on file at Boston Scientific. Represents total global sales of the PROMUS (Boston Scientific) and XIENCE (Abbott) stents since 2006.
  9. Data on file at Boston Scientific. Represents total population of patients studied in the PROMUS and XIENCE series of clinical trials.
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