NMT Medical starts US trial for PFO(patent foramen ovale)/migraine therapy STARFlex implant:
This article was originally published in Clinica
Executive Summary
NMT Medical has begun a US trial to test its heart repair implant as a treatment for migraine headaches. The MIST II trial, which has begun patient enrolment, will assess the firm's STARFlex device, which is used to close a patent foramen ovale (PFO), a cardiac defect that has been linked an increased risk of migraine, recurrent stroke and transient ischaemic attacks. It will involve 600 patients, with enrolment scheduled for completion by the end of this year. Patients will be followed-up over a one-year period. The Boston, Massachusetts firm has already completed enrolment in a UK PFO/migraine study, MIST, results from which are scheduled for release in late March or early April 2006.