Medtronic is often cited as the leader in the drug-coated balloon market. The Dublin-based company has had a firm lead with its IN.PACT solution, a device used to treat peripheral arterial disease.

However, there are a number of companies with new developments in the pipeline, that could help reshape the drug-coated balloon landscape. Philips is the latest – announcing the enrollment of the first U.S. patient in the Stellarex ILLUMENATE Below-the-Knee (BTK) IDE study.

In ILLUMENATE, Philips will evaluate the Stellarex 0.014. Amsterdam-based Philips gained access to the Stellarex brand when it acquired Spectranetics for $2.2 billion in 2017. Stellarex has also had approval since 2017, but this 354-patient trial could give Philips the ammunition it needs to get a BTK indication. (Editor’s note: Before Philips acquired Spectranetics, Medtronic’s Covidien owned Stellarex. However, to resolve antitrust concerns associated with the Medtronic/Covidien merger, Covidien sold the Stellarex brand to Spectranetics for $30 million in 2014.)

ILLUMENATE will be conducted at 45 sites across, U.S., Europe, and Australia over the next 12 to 18 months. The trial is designed to assess safety and effectiveness of the Stellarex 0.014 drug-coated balloon vs. percutaneous transluminal angioplasty (PTA) in patients with critical limb ischemia.

"Several studies have shown the safety and durability benefits of the Stellarex balloon," Mahmood Razavi, MD, FSIR, FSVM, St. Joseph's Hospital in Orange, CA and principal investigator of the ILLUMENATE BTK study, said in a release. "This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 Drug-Coated Balloon for BTK PAD and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation."

Layout of the Land

C.R. Bard once held the crown in the DCB market, having gained approval for its Lutonix technology in 2014. The Murray Hill, NJ-based company began losing share when Medtronic launched the IN.PACT Admiral in early 2015. (Editor’s note: Bard was eventually acquired by Becton Dickinson and Company for $24 billion in 2017.)

Medtronic quickly became the dominant player because of significant clinical outcomes and low drug dose, as well as the new indications for long lesions and in-stent restenosis (ISR) obtained in July and September of 2016, respectively. Medtronic also received a nod from FDA for the IN.PACT Admiral DCB to treat long superficial femoral artery (SFA) lesions up to 360mm

Not to be left out of the growing market opportunity DCBs present, Abbott Laboratories sharpened its sights on the market when it obtained the commercialization rights for SurVeil drug-coated vascular balloon from Surmodics. The deal was for up to $92 million.

Finally, Boston Scientific, the undisputed leader of tuck-in acquisitions for 2018, announced that it was eyeing 2020 to potentially launch its Ranger DCB.