Patent Foramen Ovale

NMT Medical discusses recent FDA STARFlex decision

Published in Women's Health Weekly, November 28th, 2002

In a conference call with investors, NMT Medical, Inc., (NMTI) provided further detail into the FDA panel's decision not to recommend approval of the company's premarket approval (PMA) application supplement submission for the STARFlex implant device for the closure of patent foramen ovale (PFO) in certain high-risk patient populations.

"We remain committed to our mission to develop and maintain our technical and market leadership in providing treatment to recurring stroke patients with cardiac sources of stroke," stated NMT Medical President and CEO John E. Ahern. "While we are disappointed with the panel's recommendation to not approve our PMA submission for...

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Source: Women's Health Weekly (2002-11-28)

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