NMT Medical (Boston) is on the path to bringing its StarFlex device closer to the market. The company said that it will commence data analysis for its CLOSURE I clinical trial originally scheduled for the fall of 2010 in April 2010. The trial is evaluating StarFlex's effectiveness in treating patent foramen ovale (PFO) stroke and transient ischemic attacks.
Bumping up the time table stems from an independent group of statistical advisors determining that a significant number of primary outcome events will be demonstrated in both treatment arms of the trial and will have occurred by next month, according to NMT.
The company added that by April 2010, the data is expected to have statistical power to support a primary outcome result and thus it would be scientifically appropriate to begin the analysis at that time.
At that time the company said that 99.4% of all patient follow-up months will have been completed and 95.1% of patients will have completed the two-year follow-up.
The results of the analysis are anticipated during 3Q10 at which point the trial will be complete, with 100% of the randomized patient follow-up available. If the results prove positive for device closure, the company will be in a position to submit a PMA for its Starflex device for the stroke and TIA indication to FDA.
"The Starflex is an implanted technology that is used through minimally invasive procedures to treat structural heart disease" NMT CFO Richard Davis told Medical Device Daily. "We're going down the PMA approval [pathway]."
CLOSURE I is the first clinical trial approved by the FDA that brings together stroke neurologists and cardiologists to compare two treatments for embolic stroke and determine which is the most effective.
It is being led by Principal Investigators Anthony Furlan, MD, and Mark Reisman, MD. Furlan is Chairman, Department of Neurology, Neurological Institute University Hospitals Case Medical Center, and Case Western Reserve University School of Medicine (Cleveland). Reisman is Director, Cardiovascular Research and Director, Cardiac Catheterization Lab, Swedish Heart and Vascular Institute (Seattle).
StarFlex will be compared against pharmaceutical treatments, in the trial, which will include 910 patients throughout more than 95 centers. Of the 910 stroke and TIA patients enrolled, half received treatment with NMT's StarFlex implant and half were treated with drugs alone.
Follow up for the device arm of the study will require patients to see the interventional cardiologist who implanted the STARFlex six months after the procedure. This visit will involve a chest X-ray. Depending on the results of these tests, further visits may be required.
Patients in the medical therapy arm taking warfarin will have to have their prothrombin (clotting time) rates checked weekly against international normalization ratios (INRs) until a therapeutic level of between 2 and 3 is established, then every month after that. This is a simple blood test measuring the number of seconds if takes for an individual's blood to clot. Patients taking aspirin will not need any special testing.
NMT's President/CEO Frank Martin said, "Since completing enrollment in late 2008, we have worked closely with the CLOSURE I Executive Committee to address the delicate balance between the medical community`s desire for more effective treatment options and the value of maximizing the amount of data we will file with the FDA. Commencing the data review in April 2010 should allow NMT to submit a PMA during the third quarter of 2010, assuming a positive outcome."
If the results are less than favorable then the company would have to make adjustments.
"I think that if you don't hit the primary endpoint you have to analyze the results and then see where you go from there," Davis said.
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