STORZ MEDICAL receives FDA approval for DUOLITH® SD1

STORZ MEDICAL has received the PMA approval (premarket approval) of the US Food and Drug Administration (FDA) for the DUOLITH® SD1 (Class III)*. This means that the innovative focused shock wave therapy system has now the FDA’s highest level of approval. It is approved in the USA for the treatment of heel pain due to chronic proximal plantar fasciitis**. As a result of the FDA approval, STORZ MEDICAL and its partners are now able to begin with the market launch of the DUOLITH® SD1 in the USA. The PMA approval of the device in the USA is also important for other countries as it signalizes that the DUOLITH® SD1 can be trusted when treating chronic plantar fasciitis.

»The FDA approval of the DUOLITH® SD1 is another important milestone in the history of our company that creates new growth opportunities«, STORZ MEDICAL’s managing director Dr Gerold Heine said in a statement. »Due to the strict FDA standards, the approval also increases the global confidence in our products and thus we able to contribute to a better patient care.«

*PMA P080028, for details and restrictions see:

**Study: Gollwitzer H et al. Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: a randomized, controlled multicenter study. J Bone Joint Surg Am. 2015 May 6;97(9):701-8. doi: 10.2106/JBJS.M.01331.



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Saturday, 15 August 2020

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