Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

ITT Cohort: Post thrombectomy imaging available for core lab adjudication.

Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

ITT Cohort: Post-thrombectomy imaging available for core lab and independent safety board adjudication

Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions. Procedural imaging was not available for one (1) participant.

Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions; Based on available imaging and NIHSS.

The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b

mTICI range: 0 to 3; higher score means better reperfusion

ITT Cohort

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better reperfusion

ITT Cohort: Post thrombectomy imaging available for core lab adjudication

Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

mTICI range: 0 to 3; higher score means better outcome

ITT Cohort

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better outcome

ITT Cohort: Post thrombectomy imaging available for core lab adjudication.

The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death

ITT Cohort: Subjects with completed mRS assessments

The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

ITT Cohort: Participants that completed the SIS Questionnaire

Rate of 90-day all-cause mortality

ITT Cohort

Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

ITT Cohort: Post thrombectomy imaging available for core lab adjudication.

Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

ITT Cohort: Subjects with completed ENT assessment forms

Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

ITT Cohort

All serious adverse events through 90 days post-procedure.

ITT Cohort

The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b

mTICI range: 0 to 3; higher score means better reperfusion

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better outcome

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

mTICI range: 0 to 3; higher score means better outcome

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better reperfusion

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.

Subjects with completed mRS assessments. The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter).

The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter). The sample size includes participants who completed Stroke Impact Scale (SIS) Questionnaire.

Rate of 90-day all-cause mortality

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter). One participant is missing imaging for core lab adjudication.

Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter). Participants with completed ENT forms are evaluated.

Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

All serious adverse events through 90 days post-procedure.

The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b flow.

mTICI range: 0 to 3; higher score means better reperfusion

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better reperfusion

Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

mTICI range: 0 to 3; higher score means better reperfusion

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better reperfusion

Post thrombectomy imaging available for core lab adjudication

The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.

Subjects with completed mRS assessments.

The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions in subjects completing SIS assesment

Rate of 90-day all-cause mortality

Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions; Based on available imaging: Procedural imaging was not available for one (1) participant.

Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions

All serious adverse events through 90 days post-procedure

Use of additional devices to achieve core lab adjudicated mTICI score ≥2b

Patients in whom mTICI score ≥2b was achieved

Use of additional devices to achieve mTICI Score ≥ 2b

Participants in whom mTICI Score ≥ 2b was achieved

Use of additional devices to achieve mTICI Score ≥ 2b

mTICI range: 0 to 3; higher score means better reperfusion

Participants in whom mTICI Score ≥ 2b was achieved

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2b, after all passes with the study device. Additional device use after mTICI score ≥2b was achieved with study device was not imputed as failure.

FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2b, after all passes with the study device. Additional device use after mTICI score ≥2b was achieved with study device was imputed as failure.

FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2 at the end of the procedure, including rescue therapy with non-study devices

FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions