More Indications Coming for C.R. Bard's Drug-Coated Balloon

A full year into selling its Lutonix drug-coated balloon catheter, C.R. Bard plots expanded indications for the technology.

Marie Thibault

C.R. Bard's Lutonix 035 drug-coated balloon catheter is expected to enter new indications in the coming years.

C.R. Bard's Lutonix 035 drug-coated balloon (DCB) catheter will soon reach a wider audience. The device has been on the market for just over a year in the United States and already new indications are in the works. 

Lutonix was originally approved by FDA in October 2014 for use in the thigh and knee in patients with peripheral artery disease. The DCB is used to widen or unblock arteries and apply a coating of paclitaxel to the artery walls to prevent restenosis. That original indication covered lesions of up to 150 mm in the femoropopliteal arteries with 4-6 mm reference vessel diameters, according to a company release. At that time, Lutonix was the first and only DCB approved for use by FDA. The agency approved Medtronic's IN.PACT Admiral balloon in January 2015.

Now, Bard's management is detailing a packed pipeline for Lutonix. On the company's fourth quarter earnings call this week, executives called out near-term opportunities like longer lesions and new geographies, as well as longer-term expansion into use below the knee, arteriovenous fistulae access in the upper extremities, and in-stent restenosis, according to a Seeking Alpha transcript of the call. 

John DeFord, PhD, senior vice president of Science, Technology, and Clinical Affairs at Bard told analysts that the company is readying its inventory to launch a wider range of the Lutonix line in the first quarter of 2016. That November 2015 PMA supplement approval granted use of the 7x40 mm and 7x60 mm Lutonix device sizes and expanded the reference vessel diameters from 4-6 mm to a 4-7 mm range. 

The company has also filed an FDA submission for an indication in longer lesions, up to about 300 mm. The current approval covers lesions up to 150 mm in length. DeFord summarized results presented this week at the Leipzig Interventional Course in Leipzig, Germany that showed one-year results from a retrospective, single-center study in patients with an average lesion length of over 280 millimeters. While there was not a statistical difference between patients treated with Lutonix versus stents, patients had more than 82% freedom from reintervention at one year, he said.

Clinicians in new countries may soon start using Lutonix. Bard is planning to file a submission in the first half of 2016 for Japanese regulatory approval of the DCB. A Chinese study is also expected to start ramping enrollment. 

The company has a few IDE studies running right now, too. An in-stent restenosis IDE trial, for patients who have had vessel narrowing after stent placement, is underway. Management anticipates being able to file a PMA submission in the second half of 2016 for that indication. The arteriovenous (AV) Access DCB IDE study in the upper extremities may finish enrolling patients as soon as the end of first quarter or second quarter 2016, which could lead to an FDA submission in the first half of 2017.

Finally, an IDE study for treatments below the knee (the current indication is in the thigh and knee) is expected to keep running throughout the year, with a PMA submission anticipated in late 2017 or in 2018.

These eventual expansions could mean significant sales growth for the Lutonix platform. Rick Wise, an analyst with Stifel, wrote in a January 28 research note, "Lutonix DCB Has a Long Growth Runway . . . Over the next 2+ years, indicated expansion—below-the-knee, A/V access, in-stent restenosis, etc—could increase Lutonix's addressable market by 50+%, suggesting potential for continued, meaningful through-end-of-decade growth."

John Weiland, president and chief operating officer at Bard, told analysts, "We are very pleased with the first year of our drug-coated balloon sales in the United States. Sales in Q4 were as expected, and we estimate that end customer usage, which more than doubled the prior year."

According to the Seeking Alpha transcript, Weiland also pointed to the growing acceptance of Bard's DCB technology by physicians, saying:

"After a little bit over a year into this now, physicians now are getting to the point that have started using DCBs on some of their patients, they're not only looking at the data, they're looking at the fact that patients aren't coming back for re-intervention. And as patients don't come back for re-interventions, they get great confidence in using the device on more and more and more patients in the future."

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Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of C.R. BARD, INC.]

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