FDA News

NMT Medical Receives FDA Approval for Modifications in Pivotal U.S. PFO/Stroke Trial

(April 24, 2007)--NMT Medical, an advanced medical technology company that designs, develops,manufactures and markets proprietary implant technologies that allow
interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced that it has
received conditional approval from the U.S. Food and Drug Administration (FDA) to its revised study hypothesis and statistical plan in the CLOSURE I
patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial in the U.S. As part of the revised plan, the Company plans to enroll
approximately 800 patients. The original CLOSURE I statistical plan, approved by the FDA five years ago, required an enrollment of 1,600
patients.

On March 2, 2007, NMT participated in a public and private FDA advisory panel meeting to discuss the current status of the ongoing PFO/stroke
trials being sponsored by NMT and other companies. At the close of the meeting, both the FDA and advisory panel concurred that only randomized,
controlled trials would provide the necessary data to be considered for premarket approval (PMA) for devices intended for transcatheter PFO closure
in the stroke and TIA indication. During a private session, NMT provided the FDA and advisory panel with a revised study hypothesis and statistical
plan to complete the CLOSURE I study as a randomized controlled trial.

"The FDA's acceptance of our revised plan to complete enrollment in the CLOSURE I study represents an important milestone for NMT and the medical
community," said President and Chief Executive Officer John E. Ahern. "The revision is based on the recommendations made at the recently held meeting.
As a result of this decision, we believe that we are now much closer to completing enrollment in CLOSURE I and thereby understanding the PFO/stroke
and TIA connection and the possibility that treatment with a closure device may reduce the frequency of recurrent events. The stroke and TIA
indications, which have a potential market of 250,000 U.S. patients annually, have always been a major focus for the Company."

Ahern concluded, "To date, more than 650 patients have been randomized in CLOSURE I. We are not aware of any other randomized stroke and TIA
studies as far along or with as much accumulated clinical information.Based on the revised statistical plan, we currently expect to complete
enrollment by year end. Follow-up with the patients will continue to be over a two-year period."

A PFO is a common heart defect that may be a potential risk factor for stroke, migraine, TIA or other brain attacks in some patients. The PFO
allows venous blood, unfiltered and unmanaged by the lungs, to enter the arterial blood circulation. CLOSURE I is NMT's pivotal clinical trial
designed to evaluate the effectiveness of the STARFlex technology in preventing recurrent stroke and/or TIA due to a presumed, paradoxical
embolism through a PFO.

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