A Medical Device Daily
NMT Medical (Boston) reported completing enrollment in its Migraine Intervention with STARFlex Technology (MIST) clinical study, which enrolled 147 migraine headache patients at 16 centers in the UK.
MIST, billed by NMT as “first of its kind,” is evaluating the effectiveness of the company’s STARFlex implant technology in migraine sufferers, with patients randomized to either the STARFlex implant or a control arm.
John Ahern, NMT’s president and CEO, said that the completion of patient enrollment beat initial expectations by “two full quarters.” He called preliminary data from the trial, presented at the EuroPCR meeting in Paris in May, “encouraging.”
The data revealed that 60% of migraine patients studied had a right-to-left shunt, the majority of which were a patent foramen ovale (PFO). The incidence of these shunts – allowing venous blood unfiltered and unmanaged by the lungs to enter the arterial blood circulation – is greater than the general population. In addition, more than 40% of the migraine patients studied had a large shunt, six times greater than in the general population. PFO was the most prevalent shunt seen in these migraine patients, accounting for more than 85% of all large shunts detected.
Ahern said: “If MIST determines that PFO closure with NMT’s STARFlex implant is an effective treatment for certain migraine headaches, we believe that PFO closure for migraine will be a substantial revenue growth opportunity, and NMT will be the first to have the solution.”
NMT said it expects MIST results to be available in 1Q06.
The company received approval for MIST in the UK in November 2004, with enrollment launched in January. It also recently began enrollment in another clinical trial in the UK for its BioSTAR Evaluation Study (BEST), for its bioresorbable collagen matrix PFO closure.
NMT develops interventional systems enabling treatment of cardiac sources of migraine headaches, stroke and other potential brain attacks. It also serves the pediatric interventional cardiologist with a range of cardiac septal repair implants.