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FDA panel votes against STARFlex PMA.(STARFlex implant device for the closure of patent foramen ovale )
2002 NOV 7 - (NewsRx.com & NewsRx.net) -- NMT Medical, Inc., (NMTI) announced that the Circulatory Systems Devices Panel of the U.S. Food and Drug Administration (FDA) did not recommend approval of the company's premarket approval application (PMA) for the STARFlex implant device for the closure of patent foramen ovale (PFO) in certain high-risk patient populations.
In the multicenter study supporting the FDA submission, STARFlex successfully closed PFO's in high-risk patients in, which the treatment alternatives were either contraindicated or unacceptable. At follow up, 94% of the patients studied had complete PFO closure with no recurrent strokes.
Commenting on the decision, John E. Ahern, president and CEO, said, "We are disappointed that the panel did not feel the data in the submission was strong enough to recommend approval. As we had previously indicated, we knew that moving this specific PFO indication to a PMA approval would be especially challenging and that an unfavorable panel decision was possible. However, we felt it was an important challenge to undertake given the limited alternatives available for these high-risk patients."
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Source: HighBeam Research, FDA panel votes against STARFlex PMA.(STARFlex implant device for the...