NMT submits PMA (premarket approval application) for next-generation PFO (patent foramen ovale) implant:
This article was originally published in Clinica
NMT Medical has filed a premarket approval (PMA) application with the US FDA for its STARFlex implant, a next-generation version of its minimally invasive device for the closing of a hole in the heart, called patent foramen ovale (PFO). A multicentre study supporting the FDA submission showed that 98% of the patients treated with the implant had complete PFO closure at follow up, says John Ahern NMT's president and CEO. The Boston, Massachusetts firm gained FDA approval of its earlier generation PFO closure device, CardioSEAL, under Humanitarian Device Exemption regulations last year (see Clinica No 894, p 14).
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