Choose the DCB that gives you more

New Product

Treat more with LUTONIX® 018 DCB, the first and only 018 drug coated balloon available on the US market.1
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Optimized Formulation

The LUTONIX® DCB’s optimized formulation was determined through extensive development and rigorous testing.

50,000
Balloons Tested
11,400+
Histology Samples
250+
Formulations
45
Pre-Clinical Trials
1
Final Optimized Formulation

The LUTONIX® DCB formulation was designed for the optimal balance of safety and efficacy with a purposeful low dose and appropriate excipient, which together allow for effective transfer of drug to the vessel wall while minimizing downstream effects.

Most Indications

The LUTONIX® DCB offers the most clinical indications on the U.S. Market.1

  • Femoropopliteal: 4-7 mm Diameters Available
    • Indicated for ISR and Long Lesions Up to 300 mm
  •  Dysfunctional AV Fistulae: 4-12 mm Diameters Available
Homepage_Proven-Safety_Most-Indications

Largest Offering & Lowest Profile

The LUTONIX® DCB offers the largest DCB product offering, with the lowest DCB profile, on the U.S. market.1

Homepage_Largest-Offering-&-Lowest-Profile

Learn more about the largest product offering

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LUTONIX® DCB: Leader in Innovation

December 2018
First and only DCB available on an 0.018” platform

LUTONIX® is the first and only DCB to receive FDA approval on a 0.018” wire configuration.

September 2018
First and only DCB with longer length 7mm diameter balloons

LUTONIX® is the first and only drug coated balloon with larger 7mm diameter balloons on longer lengths (80-220mm).

September 2018
First and only DCB with longer length balloons on an all-5F platform

LUTONIX® is the first and only drug coated balloon with longer 220 mm length balloons on an all-5F platform.

August 2017
First and only DCB to receive indication for Dysfunctional AV Fistulae

LUTONIX® is shown to enable longer AV fistula function due to increased time to first reintervention compared to standard angioplasty. LUTONIX® is the first DCB to offer sizes 8-12mm in diameter.

February 2017
First DCB to receive indication for long lesions (up to 300mm)

LUTONIX® is the first DCB to receive indication for long lesions that are up to 300mm.

March 2016
First and only DCB with an all-5F platform

LUTONIX® is the only DCB on the U.S. market with all sizes 5F, designed to minimize the size of the access site.

December 2015
First DCB with larger diameter balloons

LUTONIX® is the first drug coated balloon with larger 7mm diameter balloons (40-60mm).

July 2015
First and only DCB with the GEOALIGN® Marking System

The GEOALIGN® Marking System on the Lutonix DCB facilitates repeatable catheter alignment at the lesion.

July 2015
First DCB with longer length balloons

LUTONIX® is the first drug coated balloon with longer 120mm and 150mm length balloons.

October 2014
First FDA-approved DCB

LUTONIX® is the first FDA-approved drug coated balloon in the United States.

More Milestones

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    1As of September 2019

    In August 2019, the U.S. Food and Drug Administration (FDA) issued an updated letter to health care providers noting an increased risk in late mortality (2-3 years post-treatment) with paclitaxel-coated devices when used to treat peripheral arterial disease in the femoropopliteal artery as compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel-coated device exposure. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients. BD will continue to work collaboratively with FDA and industry for additional safety data collection and inform labeling as appropriate. These communications as well as information about the FDA Panel meeting can be found at: https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel

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