NMT Medical announces clinical study of major changes in U.S. plans
Ahern. MIST II, ​​which was approved by the U.S. Food and Drug Administration (FDA) in September 2005 and renovated in August 2006, had a rigorous selection of patients. Despite frequent discussions with the FDA and major initiatives to accelerate the registration process, randomization of patients resulted in slower progress than expected. Although more than 1400 patients were selected for inclusion in the trial, only a handful of patients who met the requirements to be randomized.Part of the savings will be used to further finance CLOSURE I will be completed to our central PFO / stroke and transient ischemic attack (TIA) clinical trial enrollment in the United States
The decision was difficult MIST II in the neighborhood, but in light of the challenges of
recording, a necessary and appropriate, Stewart Tepper, MD, Associate Clinical Professor of Neurology, told the Yale University School of Medicine and co-principal investigator MIST II trial. Migraine connection PFO / should be studied and understood. Future study designs should be the inclusion of patients / exclusion and their impact on the enrollment process. Mark Reisman, MD, Director of Cardiovascular Research Swedish Medical Center in Seattle, Washington and co-principal investigator of the MIST II trial, he said, to identify patients most likely to benefit from PFO closure .I still contribute to the scientific evaluation of the PFO Connection / migraine and I have the curiosity to see the definition of future study designs.Ahern said, we and our research groups
continue to recognize a link between PFO and migraine in some patients. I study in the haze we learned the treatment effect of PFO closure in migraine patients supports further investigation. The results of this pilot study was conducted in the United Kingdom should be published in the traffic of the start of this year. As a leader in the field, NMT remains committed to studying the connection PFO / migraine.We will continue to Pages: [1] 2 3