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PMA P180031S006

Device
Neuroform Atlas® Stent System
Applicant
Stryker Neurovascular
PMA number
P180031
Supplement
S006
Product code
QCA
Decision date
2025-06-24
Classification
Neurology
Generic name
Intracranial coil-assist stent
Approval order statement
PMA was approved on May 16, 2019 with the following conditions of approval:PMA Post-Approval Study: “Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas™ Stent System (ATLAS)”: The Office of Neurological and Physical Medicine Devices (Office of Health Technology (OHT) 5) will have the lead for this study initiated prior to device approval. The ATLAS study was conducted under investigational device exemption (IDE) G150006 and patients were consented to be followed for up to three (3) years post-operative. The 1-year follow-up data from the ATLAS study was used to support the approval of the subject PMA P180031. As part of the PMA post-approval study, the long-term follow-up from the ATLAS study can provide safety and effectiveness information on the durability and safety of treatment using the Neuroform Atlas Stent System up to 3 years post-operative. The pre-specified safety endpoint is the incidence of patients who experienced a major ipsilateral stroke or neurological death. The pre-specified effectiveness endpoint is the incidence of patients who had complete (100%) intracranial aneurysm occlusion (Raymond-Roy Class 1) without significant in-stent stenosis (> 50%) or retreatment of the target aneurysm. The incidence of all ischemic or hemorrhagic adverse events (i.e., ischemic and hemorrhagic, ipsilateral and contralateral, of all severities, at all times after enrollment, and of any duration, including transient ischemic attacks (TIAs)) should also be reported as part of the long-term safety analysis. Patients will be assessed at 2- and 3-years (within ± 6 months) post-operative with neurological exams conducted in person per the G150006 clinical study protocol. In addition, all new and ongoing adverse events will be recorded and adjudicated by the Clinical Events Committee per the approved G150006 clinical study protocol. Imaging assessment of intracranial aneurysm occlusion and in-stent stenosis will be performed after 1-year post-operative if imaging assessments will be performed as part of usual care.

Current openFDA PMA Record#

Device
Neuroform Atlas® Stent System
Applicant
Stryker Neurovascular
PMA number
P180031
Supplement
S006
Product code
QCA
Generic name
Intracranial coil-assist stent
Decision date
2025-06-24
Decision code
APPR
Date received
2024-08-12
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - PAS
Approval order statement
PMA was approved on May 16, 2019 with the following conditions of approval:PMA Post-Approval Study: “Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas™ Stent System (ATLAS)”: The Office of Neurological and Physical Medicine Devices (Office of Health Technology (OHT) 5) will have the lead for this study initiated prior to device approval. The ATLAS study was conducted under investigational device exemption (IDE) G150006 and patients were consented to be followed for up to three (3) years post-operative. The 1-year follow-up data from the ATLAS study was used to support the approval of the subject PMA P180031. As part of the PMA post-approval study, the long-term follow-up from the ATLAS study can provide safety and effectiveness information on the durability and safety of treatment using the Neuroform Atlas Stent System up to 3 years post-operative. The pre-specified safety endpoint is the incidence of patients who experienced a major ipsilateral stroke or neurological death. The pre-specified effectiveness endpoint is the incidence of patients who had complete (100%) intracranial aneurysm occlusion (Raymond-Roy Class 1) without significant in-stent stenosis (> 50%) or retreatment of the target aneurysm. The incidence of all ischemic or hemorrhagic adverse events (i.e., ischemic and hemorrhagic, ipsilateral and contralateral, of all severities, at all times after enrollment, and of any duration, including transient ischemic attacks (TIAs)) should also be reported as part of the long-term safety analysis. Patients will be assessed at 2- and 3-years (within ± 6 months) post-operative with neurological exams conducted in person per the G150006 clinical study protocol. In addition, all new and ongoing adverse events will be recorded and adjudicated by the Clinical Events Committee per the approved G150006 clinical study protocol. Imaging assessment of intracranial aneurysm occlusion and in-stent stenosis will be performed after 1-year post-operative if imaging assessments will be performed as part of usual care.