PREMIUM Migraine Trial

A 50% reduction from the monthly number of migraine attacks during the 60-day baseline phase to the monthly number of migraine attacks during month ten through the twelfth month in the treatment phase (device group versus sham group).

Time frame: Baseline and months 10-12

Population: Participants included in the analysis were followed for 1-year, had Clinical Event Committee (CEC) adjudicated headache diaries, had greater than or equal to 60% diary compliance during the treatment phase (10-12 months) and were not treatment failures.

Number of subjects who experience a device-related major adverse event (DRMAE) through 12-months of follow-up. This endpoint was analyzed using an as-treated cohort that consists of all enrolled subjects who received the device (randomized and Optional PFO Closure group) and who had follow-up sufficient to adequately assess the DRMAE rate.

Time frame: Baseline through 12 months

Population: All enrolled subjects who received the device (randomized and Optional PFO Closure group). 5 subjects were considered to have insufficient follow-up and were therefore excluded from the analysis.

Change in the number of migraine days is calculated by the difference in the mean number of migraine days between the baseline assessment period and the treatment phase (months 10-12 post-procedure) for the respective randomization groups.

Time frame: Baseline and months 10-12

The MIDAS questionnaire measure the impact of headaches on daily living. A total score of 0-5 equals little to no disability, 6-10 equals mild disability, 11-20 equals moderate disability, and a score 21 or greater equals severe disability. The maximum possible score is 276.

Time frame: 12 months

Population: 101 participants in the sham group and 116 subjects in the PFO device closure group had both baseline and 12-month MIDAS scores available to perform the analysis.

Time frame: 12 months

Population: Participants were included in the analysis were followed for 1-year, have CEC adjudicated headache diaries, had greater than or equal to 60% diary compliance during the treatment phase (10-12 months) and were not treatment failures.

Time frame: 12-months

Time frame: 12 months

Population: Participants who experienced an adverse event at or before 12-months post-procedure

Time frame: 12 months

Population: Participants who experienced a device-related adverse event, as adjudicated by the Data Safety and Monitoring Board (DSMB), at or before 12-months post-procedure.

Percent of PFO closure group subjects who were implanted with the study device, experienced no serious device or procedure-related adverse events and have a core-lab adjudicated TCD Grade at Valsalva ≤ 2 at 1-year.

Time frame: 12 months

Population: Percent of PFO closure group subjects who were implanted with the study device, experienced no serious device or procedure-related adverse events and have a core-lab adjudicated TCD Grade at Valsalva ≤ 2 at 1-year. 117 device subjects completed the 12 month visit. Only 104 had TCDs that were able to be adjudicated.

Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade \<= 2

Time frame: Baseline and month 12

Population: 117 device subjects completed the 12 month visit. Only 104 had TCDs that were able to be adjudicated. Of the 13 device subjects with unadjudicated TCDs, 4 did not have valsalva data and 9 did not have TCD data available for various reasons.

Procedural success is calculated by the percent of device group subjects who were implanted with the study device and experienced no serious device or procedure-related adverse events.

Time frame: 12 months

Population: Device group subjects who were implanted with the study device and experienced no serious device or procedure-related adverse events.

The difference in BDI between baseline and 12-months for the respective randomization groups. The highest possible score of the BDI is 63, which represents extreme depression. The lowest possible score is 0, which represents no depression.

Time frame: 12 months

Population: 101 participants in the sham group and 116 subjects in the PFO device closure group had both baseline and 12-month BDI scores available to perform the analysis.

Complete Cessation of Migraine Attacks, baseline diary compared to months 10-12

Time frame: Baseline through months 10-12

Population: 6 PFO Device Closure Subjects and 3 Sham Procedure Subjects with Aura do not have 12-month follow-up data available.

The term majority in majority of migraine attacks included aura was defined by the Neurologist (\>50%) at the time of randomization based on a review of the subject's study baseline headache diary and medical history.

Time frame: 12 months