SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms.
The data from this study will be used to support a premarket approval (PMA) submission.
SEAL™ ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry
Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System.
Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial
To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms.
The data from this study will be used to support:
1. EU CE Mark labelling
2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval.
100 Clinical Results associated with Galaxy Therapeutics, Inc.
0 Patents (Medical) associated with Galaxy Therapeutics, Inc.
100 Deals associated with Galaxy Therapeutics, Inc.
100 Translational Medicine associated with Galaxy Therapeutics, Inc.