Peripheral drug-coated balloon market makes strides, but may be hindered by COVID-19

While there has been movement within the drug-coated balloon (DCB) market, data and analytics company GlobalData expects that the ongoing COVID-19 pandemic will hinder the growth opportunities for DCBs, including Boston Scientific’s Ranger, which recently received FDA approval. Given the non-essential nature of the procedure and restrictions, GlobalData estimates that percutaneous transluminal angioplasty (PTA) balloon procedures declined by almost 30% in 2020. Concerns surrounding the pandemic may extend to continued caution around paclitaxel-coated balloons, as well as an overall impact on procedural growth.

Sheryl Tang, Principal Medical Devices Analyst at GlobalData, comments: “Both the Ranger and Stellarex DCB devices are paclitaxel-coated balloons (PCB). A meta-analysis published by Katsanos et al in 2018 showed a potential link between the use of paclitaxel-coated devices and an increased risk of late mortality at two and five years posttreatment.

“Since the release of the publication, GlobalData estimated a 50% decline in PCB usage each year due to heightened caution surrounding its use, resulting in a shift toward non-coated balloons in the treatment of lower limb peripheral artery disease (PAD). The caution surrounding PCB usage opened the market opportunity up to sirolimus-coated balloons as the safer DCB alternative.

“While paclitaxel DCBs have the lion’s share of the DCB market, GlobalData expects Concept Medical’s DCB to gain some share with the continuing caution around paclitaxel balloons, and this opportunity would be strengthened with a successful trial.”

The recent four-year results from Philips supports previously presented results from their ILLUMENATE randomized control trials, showing low mortality rates each year. These results may improve the confidence in using PCBs, given its anti-restenotic properties, as well as faster absorption rates and longer retention compared to sirolimus-coated balloons.

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