GORE INITIATES THE RELIEF CLINICAL STUDY EVALUATING PFO CLOSURE FOR MIGRAINE HEADACHE RELIEF

CAUTION: Investigational device. Limited by United States law to investigational use.

The Gore RELIEF study is evaluating the safety and efficacy of transcatheter closure of patent foramen ovale (PFO) with the GORE® CARDIOFORM Septal Occluder for the relief of migraine headaches.

FLAGSTAFF, Ariz., Nov. 9, 2022 /PRNewswire/ -- W. L. Gore & Associates (Gore) announced today that it is initiating the 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 utilizing the GORE® CARDIOFORM Septal Occluder, a permanently implanted device.

"The Gore RELIEF Clinical Study will investigate 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, M.D., 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."

The multi-center, prospective, randomized, placebo- and sham- controlled RELIEF study seeks a final enrollment of 150 patients responsive to the study drug, with documented PFO, ages 18 to 55, 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 subjects with any serious adverse event (SAE) related to the study device or study procedure through 30 days post procedure.

"The RELIEF Clinical Study is another example of Gore's commitment to research with the goal of improving lives," said Jake Goble, PhD, Innovation Leader and Cardiac Business Leader for Gore's Medical Products Division. "The study incorporates the learnings from past PFO-migraine studies targeting a patient population we hypothesize may truly benefit. We are excited to reach this milestone as we continue to pursue a potentially impactful treatment option for migraine headache relief."

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. The minimal, nitinol wire frame covered with ePTFE, conforms to the adjacent, native anatomy facilitating high closure rates with rapid tissue ingrowth with zero reported cardiac erosions.* With over 60,000 devices sold globally and 11 years† of clinical use, the GORE CARDIOFORM Septal Occluder is trusted by physicians and patients for its safety and performance in its approved indications.

The GORE CARDIOFORM Septal Occluder received U.S. Food and Drug Administration 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. Furthermore, it is approved in the United States and European Union for closure of a type of atrial septal defect.‡

Additional information about the clinical study is available at www.clinicaltrials.gov

* Reported incidence rate of device-related cardiac erosions for GORE® CARDIOFORM Septal Occluder. Data from CATSWeb Product Surveillance Tracking System (PSTS). June, 2011 – August, 2022.

† Beginning in June 2011.

‡ For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU).

Products listed may not be available in all markets.

Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 50 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. For more information, visit goremedical.com

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 12,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $4.5 billion. For more information, visit gore.com.

SOURCE W. L. Gore & Associates, Inc. MPD Division