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  1. Cardiovascular Devices

Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease

Paclitaxel-coated balloons and paclitaxel-eluting stents are intended to treat de novo (new) or restenotic (recurring) atherosclerotic lesions in the femoropopliteal artery. The balloon and stent work to mechanically open the blocked blood vessel. Paclitaxel is delivered from the balloon or stent to prevent scar tissue formation in the blood vessel that can re-narrow the artery.

Paclitaxel-coated balloons and stents have been shown to improve blood flow to the legs and decrease the need for repeat procedures to reopen blocked blood vessels.

On this page:

Paclitaxel-Coated Balloons and Stents Approved in the United States 

Manufacturer Name

Device Name

Decision Date

PMA Number

Cook Ireland Ltd.

Zilver PTX Drug-Eluting Peripheral Stent

11/14/2012

P100022

P100022/S020

Lutonix, Inc

LUTONIX 035 Drug Coated Balloon PTA Catheter

10/09/2014

P130024

P130024/S009

Medtronic, Inc.

IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

12/30/2014

P140010

P140010/S015

P140010/S037

The Spectranetics Corporation/Philips

Stellarex 0.035” OTW Drug-Coated
Angioplasty Balloon

07/26/2017

P160049

Boston Scientific Corporation

ELUVIA Drug-Eluting Vascular Stent
System

09/18/2018

P180011

Boston Scientific Corporation

Ranger Paclitaxel-Coated PTA Balloon
Catheter

10/30/2020

P190019

Recommendations for Health Care Providers

The FDA continues to recommend that health care providers:

  • Continue close monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.
  • When making treatment recommendations, and as part of the informed consent process, consider that there may be an increased rate of long-term mortality in patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents. 
  • Discuss the benefits and risks, including the possibility of increased mortality, of all available peripheral artery disease (PAD) treatment options with your patients. 
    • For some patients, alternative treatment options to paclitaxel-coated balloons and paclitaxel-eluting stents could provide a more favorable benefit-risk profile.
    • For others, clinicians may determine that the benefits of using a paclitaxel-coated device may outweigh the risk of late mortality.
    • In discussing treatment options, physicians should explore their patients’ expectations, concerns, and treatment preferences.
  • Ensure patients receive optimal medical therapy for PAD and other cardiovascular risk factors as well as guidance on healthy lifestyles including weight control, smoking cessation, and exercise.
  • Report adverse events or suspected adverse events experienced by patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Risks Associated with Paclitaxel-Coated Balloons and Stents

The FDA continues to evaluate and provide the latest information regarding the potential for increased risk for late mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat PAD in the femoropopliteal artery. 

Late Mortality Risk for Paclitaxel-Coated Balloons and Stents 

A meta-analysis of randomized trials published in the Journal of the American Heart Association (JAHA) in late 2018 suggested an increased mortality rate beginning after two years in PAD patients treated with paclitaxel-coated balloons and stents compared to patients treated with control devices (non-coated balloons or bare metal stents). The specific cause for the increased late mortality risk has not been determined.  

The FDA notified health care providers of the potential late mortality safety signal in letters to health care providers on January 17 and March 15, 2019.

On June 19-20, 2019, the FDA convened a public meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to discuss and make recommendations on the potential late mortality signal after treatment with paclitaxel-coated balloons and stents. The FDA's meta-analysis of long-term follow-up data from the pivotal premarket randomized trials for paclitaxel-coated devices used to treat PAD showed an increased risk of late mortality in study subjects treated with paclitaxel-coated devices compared to those treated with uncoated devices. The relative risk for increased mortality at five years was 1.57 (95% confidence interval 1.16 – 2.13).

The FDA updated its notification to health care providers on August 7, 2019. Based on the analysis and advisory panel recommendations, the FDA took additional steps including working with manufacturers on updates to device labeling and informed consent documents for ongoing clinical trials to incorporate information about the late mortality risk. 

Additional Data Assessing Late Mortality Risk

A meta-analysis performed by VIVA (Vascular InterVentional Advances) Physicians of patient-level data provided by manufacturers reported a late mortality risk that was generally similar to FDA’s assessment with a hazard ratio of 1.38 (95% confidence interval 1.06 - 1.80) associated with the use of paclitaxel-coated devices compared to uncoated devices. 
Additional data has been analyzed from clinical trials and registries on the late mortality risk for paclitaxel coated balloons and stents:

These studies have not identified a late mortality safety signal associated with the use of paclitaxel-coated devices, but the amount of long-term data is limited. At present, it is unclear why the pivotal randomized clinical trial results are discordant from non-randomized clinical trial data in regard to the late mortality risk associated with paclitaxel-coated devices. 

The FDA published its perspective in the New England Journal of Medicine (NEJM) in January 2021 describing clinical considerations on the use of paclitaxel-coated devices. 

The FDA’s Current Activities

The FDA continues to analyze new data as it becomes available. In addition, the FDA continues to collaborate with device manufacturers, clinical investigators, and clinical societies for additional clinical evidence development to assess the long-term safety of paclitaxel-coated devices. 

To date, the FDA is participating in the following additional analyses that are currently underway:

  • Pan-Industry updated analysis: This analysis includes a re-evaluation of the mortality signal using updated clinical study data, which includes additional long-term follow-up and study data that was not evaluated in the original VIVA analysis.
  • Registry Assessment of Peripheral Interventional Devices (RAPID): This public/private partnership has been collaborating to re-evaluate relevant data sources, including registries and other real-world evidence (RWE) data.

The FDA continues to publish articles (see Resources below) and present at conferences to inform the clinical community of the FDA’s perspectives on these devices.

The FDA will continue to collaborate with device manufacturers and investigators to ensure that labeling accurately describes the benefits and risks associated with paclitaxel-coated devices. 

Resources

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