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news.NMT Medical, a medical technology company, has completed patient enrollment in its pivotal patent foramen ovale/stroke clinical trial, Closure I.
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NMT believes that it is the first company to complete enrollment of a prospective, multi-center, randomized, controlled study that examines the potential relationship between patent foramen ovale (PFO) and stroke and transient ischemic attacks (TIA). The company also believes it will be first to submit a pre-market approval application to the FDA for the PFO/stroke and TIA indication.
Closure I is designed to compare the effectiveness of the StarFlex septal repair implant technology against drug therapy in reducing the risk of recurrent stroke and TIA in patients with a PFO. Of the 900 stroke and TIA patients enrolled in the study, half received PFO closure in a catheter-based procedure with NMT’s StareFlex implant and half will be treated with drugs alone.
More than 190 leading stroke neurologists and interventional cardiologists at approximately 95 centers in the US, Canada and the UK are participating in the Closure I study.
John Ahern, president and CEO of NMT Medical, said: “Completing patient enrollment in our Closure I clinical trial is an important milestone for NMT Medical and our investigator partners. We believe that data from Closure I will help the clinical community and stroke and TIA patients diagnosed with a PFO shunt make informed decisions as to the best course of therapy.”