RELIEF clinical study of PFO closure for migraine relief begins randomisation

Gore’s Cardioform septal occluder

Patients have passed through the multi-month enhanced screening process and have begun entering the final randomisation phase of the Gore RELIEF clinical study, an investigational study to evaluate the safety and efficacy of transcatheter closure of patent foramen ovale (PFO) for the relief of migraine headaches utilising the Gore Cardioform Septal Occluder, WL Gore has announced.

“The RELIEF clinical study investigates whether PFO closure may reduce the number of monthly migraine headache days for select patients. No previous PFO closure migraine trial has yet included such clearly defined selection criteria designed to identify those patients expected to most likely respond to this potential, PFO-mediated mechanism,” said Robert Sommer (Columbia University Irving Medical Center, New York, USA), national principal investigator, RELIEF clinical study. “Clinical experiences have suggested a platelet-based connection between migraine and PFO, and there may be a correlation between PFO closure responsiveness and thienopyridine responsiveness. PFO closure may offer a mechanical method to reduce or eliminate this trigger factor.”

Gore has been actively screening patients in the USA since initiating the trial in November of 2022. The enhanced screening process identifies the targeted 150 patients found responsive to the study drug, with a documented PFO and history of more than one migraine headache day per week.

The device in the study, the GORE Cardioform septal occluder, combines unique materials and is designed to provide a soft and conformable option for PFO closure, currently indicated for secondary stroke prevention in select patients. Gore has sold over 68,000 of the devices globally with 12 years of clinical use.

The device received US Food and Drug Administration (FDA) premarket approval in 2018 for the percutaneous closure of PFO to reduce the risk of recurrent stroke in select patients. It is also approved in the European Union (EU) for percutaneous closure of PFO. Furthermore, it is approved in the USA and EU for closure of a type of atrial septal defect.


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