On August 24, the FDA announced the successful 510(k) application of Medtronic’s TurboHawk Plus Directional Atherectomy System. Credit: JHVEPhoto / Shutterstock.

Medtronic controls 90% of the global market share for directional atherectomy devices used in peripheral artery disease (PAD) interventions, thanks to its HawkOne Directional Atherectomy System. On August 24, the FDA announced the successful 510(k) application of Medtronic’s TurboHawk Plus Directional Atherectomy System, an updated version of its older and largely phased out atherectomy device. GlobalData anticipates Medtronic will be using its new device to support market growth outside of the US.

Medtronic’s portfolio includes HawkOne, SilverHawk, and TurboHawk systems. The latter devices were Medtronic’s original product offerings, with HawkOne being launched in 2015. Since then, HawkOne has become the device of choice, leading to very low utilisation of the earlier systems. Furthermore, both of them have experienced various recalls over the years. GlobalData reports that the Peripheral Directional Atherectomy market will be worth $140m by 2025 based on current growth trends. However, the devices and procedures are currently only popular in the US, leaving a largely untapped global market.

The approval of Medtronic’s TurboHawk Plus highlights the importance of diverse product offerings in medical device markets. By providing multiple products in the same market, Medtronic can better control price dynamics and leverage this to support market growth in global markets. Additionally, diverse product portfolios allow the company to cater to patient-specific conditions, which will facilitate the increase of atherectomy procedures during PAD interventions.

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Peripheral Directional Atherectomy is the competing procedure to Peripheral Rotational Atherectomy led by Boston Scientific. Outside of the US, rotational atherectomy is the more common procedure type. It is important for Medtronic to bolster its Directional Atherectomy devices to increase its ability to compete in the PAD interventions market.