Autonomic Technologies has announced that the College of the French National Authority for Health (HAS) issued a favourable opinion on a Forfait Innovation package for the Pulsante SPG Microstimulator System. The award will support a randomised controlled trial for patients suffering from cluster headache. Autonomic Technologies is a medical device company focused on the development and commercialisation of innovative therapies for the treatment of severe headache.
The Forfait Innovation program was launched to accelerate the introduction of promising medical innovation in France while simultaneously collecting data to support a longer-term reimbursement decision. Funding is allocated only to select medical technologies that demonstrate truly breakthrough innovation that brings significant clinical benefits and/or reduces healthcare system costs.
“Five years after our participation in the European Pathway CH-1 study, this is an important step in allowing use of the innovative sphenopalatine ganglion stimulation system at French tertiary headache centres to treat severe cluster headache sufferers,” said Michel Lantéri-Minet, a neurologist at Centre Hospitalier Universitaire de Nice.
Centres across France will participate in the clinical study for pain relief in patients suffering from cluster headache. The costs of the study will be underwritten by the French national insurance system in partnership with Autonomic Technologies.
“We’re thrilled that the National Authority for Health has chosen to recognise the innovative approach of Pulsante therapy and develop further evidence of its ability to help patients suffering from this debilitating disease,” said Niamh Pellegrini, president and CEO.