August 27, 2019 — Concept Medical was recently granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for below-the-knee (BTK) use of its MagicTouch drug-coated balloon catheter (DCB) for the treatment of peripheral artery disease (PAD). The company is now in a position to potentially disrupt this market and become a threat to larger manufacturers that have an established presence in the peripheral space, according to data and analytics company GlobalData.
In the U.S., there are currently three FDA-approved drug-coated balloons for treating above-the-knee PAD: Medtronic’s In.Pact Admiral, Becton Dickinson’s Lutonix and Philips’ Stellarex.
Sheryl Tang, senior medical devices analyst at GlobalData, commented, “Despite the heightened caution surrounding paclitaxel-coated devices, there is still a large unmet need for BTK DCB interventions for high-risk patients who may require the benefits of drug-coated devices such as limiting the blockage or re-growth of plaques post-intervention, thereby limiting the need for re-intervention.”
Companies are racing to enter and monopolize the U.S. BTK DCB market, recognizing that it is a market with great potential and no current competition.
Tang continued, “If Concept Medical is the first company to receive approval for BTK DCB use, it would not only monopolize the large untapped market, but could potentially steal market share from Medtronic, Philips and Becton Dickinson in the DCB space.”
Additionally, with a new type of balloon on the market for patients with BTK PAD, Concept Medical could take a portion of the patient pool that is currently only treated with regular balloons, taking market share from major manufacturers in that space as well. However, as it is a smaller company in a market dominated by major manufacturers with large device portfolios, Concept Medical will also be a target for acquisition.
For more information: www.globaldata.com
September 12, 2025 
