Hydrosoft and Hydrosoft Plus Embolization Coil Systems

FDA-Cleared Indications

• Embolization of intracranial aneurysms.
• Treatment of cerebral aneurysms using endovascular coil placement.

Clinical Applications

• Endovascular coiling of selected ruptured intracranial aneurysms.
• Endovascular treatment of selected unruptured intracranial aneurysms.
• Placement through a neurovascular microcatheter to fill the aneurysm sac and promote thrombosis.
• Treatment of aneurysms when an endovascular approach is selected instead of, or as an alternative to, surgical clipping.

Reported off-label uses

• Coil embolization of selected intracranial vascular lesions other than aneurysms, such as some arteriovenous fistulas, depending on the device configuration and operator judgment.
• Adjunctive use in selected extracranial or peripheral embolization procedures has been reported for coil devices, but this is outside the stated neurovascular indication.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The coils are available in multiple diameters and lengths; selection depends on the aneurysm's size, shape, neck, and the intended packing strategy.
• They are delivered through compatible neurovascular microcatheters under fluoroscopic and angiographic guidance.
• Treatment generally requires arterial access, commonly through the femoral or radial artery, and is performed with general anesthesia or monitored sedation depending on the case.
• MRI safety and conditional-use requirements must be confirmed from the current device labeling and implant documentation before MRI, including the field strength and scanning conditions.
• Contraindications and limitations include inability to safely access the aneurysm, unsuitable vascular anatomy, severe contrast or antithrombotic medication contraindications, and patient factors that make endovascular treatment unsafe.