April 24, 2007 — NMT Medical Inc. has announced it has received conditional approval from the 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.
NMT is a 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
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.
"It is very important to obtain an answer to the stroke/PFO connection based upon a randomized controlled clinical trial,” said Anthony Furlan, M.D., associate director Cerebrovascular Center, Neurological Institute, Cleveland Clinic, and the principal investigator of CLOSURE I. “The Executive Committee and investigators are excited about the recent FDA acceptance of a revised statistical plan and the prospects for completing this important study. The answers from CLOSURE I will help determine the best treatment for patients presenting with cryptogenic stroke and TIA that also have a right to left shunt through a PFO."
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."
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