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Paclitaxel use
in SFA devices

Safe and effective treatment for PAD

Why choose paclitaxel devices to treat SFA​

Paclitaxel has been proven to inhibit restenosis by disrupting the cell-division process that causes it, and to offer superior tissue transfer and retention compared to other drugs.1 ​

The long-term safety and efficacy of paclitaxel have been meticulously studied, and its use in the Superficial Femoral Artery endorsed by both CIRSE and the FDA. ​

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  • Interferes with cell division to slow restenosis
  • Superior tissue transfer and retention compared to other drugs1
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  • Proven safe and effective endorsed by the FDA and CIRSE

FDA and CIRSE support the use of paclitaxel for SFA treatment

FDA

Recent FDA announcement: paclitaxel-coated devices no longer associated with increased mortality risk in PAD treatment. The U.S. Food and Drug Administration (FDA) published a letter to healthcare providers stating that, based on its review of the totality of the available data and analyses, the excess risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported.

Read the full statement here
Cirse

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has determined the large body of long-term clinical data do not support an excess mortality risk for paclitaxel-coated devices used to treat patients with PAD and that recent pooled data show their improved efficacy versus no-drug devices.


 

Read the full statement here

Paclitaxel devices are effective: DCB vs PTA

There is a wealth of evidence to support the efficacy benefit of using a paclitaxel-coated balloon versus PTA.  Randomised controlled trials demonstrate beyond doubt that paclitaxel increases primary patency versus non-coated balloons by reducing restenosis2-6 ​

Paclitaxel devices are effective: DCB vs PTA

Paclitaxel devices are effective: DES vs BMS

The EMINENT randomised-controlled trial provides level-1 evidence of superior primary patency outcomes of the Eluvia™ paclitaxel-eluting stent versus bare-metal stents (BMS).  It demonstrates the efficacy of paclitaxel in reducing restenosis to increase primary patency rates.2-6​

Paclitaxel devices are effective: DES vs BMS

EMINENT is the only RCT to prove superiority of DES over BMS6

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References

 
  1. Linn YL, Choke ETC, Yap CJQ, et al. Utility of sirolimus coated balloons in the peripheral vasculature - a review of the current literature. CVIR Endovasc. 2022;5(1):29.​
  2. Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. 2019;12(6):e007702. ​
  3. Stellarex 035 Instructions for Use, Sep 2019.​
  4. ClinicalTrials.gov, Identifier: NCT01412541 LEVANT 2.​
  5. RANGER II SFA 2 Year Results presented by Ravish Sachar, MD. VIVA 2021.​
  6. Gouëffic Y, Torsello G, Zeller T, et al; EMINENT Investigators. Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial. Circulation. 2022;146(21):1564–157.

Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.