Gore’s Cardioform Septal Occluder Studied for Migraine Relief

October 23, 2023—Gore & Associates recently announced the commencement of enrollment in the RELIEF clinical study. RELIEF is evaluating the safety and efficacy of transcatheter closure of patent foramen ovale (PFO) for the relief of migraine headaches using Gore’s Cardioform septal occluder.

Patients are now entering the randomization phase of the study after passing through an enhanced screening process in the United States initiated in November 2022. The screening process identified 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.

Robert Sommer, MD, is the national principal investigator of the RELIEF clinical study.

“The RELIEF clinical study investigates whether PFO closure may reduce the number of monthly migraine headache days for select patients,” commented Dr. Sommer in Gore’s press release. “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.

“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 advised that Cardioform is currently indicated for secondary stroke prevention in select patients. The device received 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 for percutaneous closure of PFO. Also, it is approved in the United States and European Union for closure of a type of atrial septal defect.

The Cardioform septal occluder is an investigational device limited by United States law to investigational use for the indication of migraine relief, noted the company.