Gore’s Cardioform Septal Occluder to Be Evaluated for PFO Closure for Relief of Migraine Headache

November 9, 2022—Gore & Associates announced that it is initiating RELIEF, an investigational clinical study to evaluate the safety and efficacy of transcatheter closure of patent foramen ovale (PFO) for the relief of migraine headaches utilizing the company’s Cardioform septal occluder, a permanently implanted device that is limited by United States law to investigational use for this indication.

The multicenter, prospective, randomized, placebo- and sham- controlled study seeks to enroll 150 patients responsive to the study drug, with documented PFO, aged 18 to 55 years, and with a history of more than one migraine headache day per week.

The primary efficacy endpoint will be a reduction in the mean number of migraine headache days, comparing the reduction in the number of migraine headache days per month from baseline to follow-up. The primary safety endpoint is the proportion of patients with any serious adverse event related to the study device or study procedure through 30 days postprocedure, advised Gore.

The RELIEF study will be led by National Principal Investigator Robert Sommer, MD.

“The Gore RELIEF clinical study will investigate whether PFO closure may reduce the number of monthly migraine headache days for select patients,” commented Dr. Sommer in the company'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.”

Dr. Sommer further stated, “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.”

The Gore Cardioform septal occluder 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. Additionally, it is approved in the United States and European Union for closure of a type of atrial septal defect, advised Gore.