đź“‹ FDA Reference
hydrosoft and hydrosoft plus embolization coil systems
Microvention
Summary: The HydroSoft and HydroSoft Plus embolization coil systems are used to treat intracranial aneurysms. They are primarily used by interventional neuroradiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K080666 ↗
Decision Date
July 11, 2008
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The HydroSoft and HydroSoft Plus embolization coil systems were cleared through the FDA 510(k) pathway on July 11, 2008. Manufactured by Microvention, these devices are classified as Class 2 under product code HCG.
What It Is
The HydroSoft and HydroSoft Plus embolization coil systems are medical devices designed to treat intracranial aneurysms. These coils are deployed within the aneurysm sac to promote blood clotting and reduce the risk of rupture. The coils are made of soft, flexible materials that conform to the aneurysm's shape, providing a scaffold for thrombus formation.
Clinical Applications
These embolization coils are commonly used in the treatment of cerebral aneurysms, particularly in patients where surgical clipping is not feasible. They are deployed in interventional neuroradiology suites, often in tertiary care hospitals. The devices are used in adult patients with aneurysms that are at risk of rupture, providing a minimally invasive alternative to open surgery.
Indications for Use
The HydroSoft and HydroSoft Plus coils are indicated for the embolization of intracranial aneurysms. They are used in patients with aneurysms that pose a risk of bleeding, helping to stabilize the aneurysm and prevent rupture.
Practical Considerations
The coils come in various sizes to accommodate different aneurysm dimensions. They are compatible with standard microcatheter systems used in neurointerventional procedures. Proper technique involves careful navigation and deployment to ensure optimal placement and aneurysm occlusion.
Related Literature
The linked study, 'Registry for Study of Coils in Intracranial Aneurysms,' aimed to evaluate the safety and efficacy of coil embolization in treating cerebral aneurysms. Although the abstract is not available, such registries typically collect data on procedural outcomes and complications. Limitations may include the lack of randomized control and potential selection bias.
Frequently Asked Questions
What is HydroSoft and HydroSoft Plus used for?
These devices are used for the embolization of intracranial aneurysms to prevent rupture and bleeding.
What specialties typically use this device?
Interventional neuroradiologists and neurosurgeons specializing in endovascular procedures use these devices.
What are the FDA-cleared indications?
The devices are indicated for the embolization of intracranial aneurysms to reduce the risk of rupture.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.