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angiojet family of thrombectomy sets
Boston Scientific
Summary: The AngioJet family of thrombectomy sets by Boston Scientific is used for mechanical thrombectomy in venous systems. It is primarily used by interventional radiologists and cardiologists to remove thrombus from blood vessels.
FDA Clearance Information
Pathway
PMA
Number
P980037 ↗
Decision Date
September 4, 2014
Product Code
MCX
Device Class
Class 3
Evidence
0 studies
The AngioJet thrombectomy sets received FDA clearance through the PMA pathway on September 4, 2014. Manufactured by Boston Scientific, this Class 3 device is designed for mechanical thrombectomy in venous systems.
What It Is
The AngioJet thrombectomy sets are medical devices used for the removal of thrombus (blood clots) from blood vessels. They function by using a high-speed saline jet to create a vacuum that breaks up and removes the clot. This device is particularly useful in cases where rapid restoration of blood flow is necessary, and it is designed to be minimally invasive.
Clinical Applications
These thrombectomy sets are commonly used in interventional radiology and cardiology settings, particularly for patients with deep vein thrombosis (DVT) or pulmonary embolism (PE). They are also used in cases of acute limb ischemia and other conditions where clot removal is critical. The device is suitable for use in hospital settings, especially in catheterization labs and vascular surgery suites.
Indications for Use
The FDA-cleared indication for the AngioJet thrombectomy sets involves the use of an alternate component vendor for the low-pressure pump seal. Clinically, this means the device is approved for use in procedures requiring mechanical thrombectomy in the venous system, such as removing clots from veins.
Practical Considerations
The AngioJet system is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheterization techniques and requires training for optimal use. Clinicians should be aware of the potential for hemolysis and ensure proper technique to minimize complications.
Frequently Asked Questions
What is AngioJet used for?
The AngioJet is used for mechanical thrombectomy to remove blood clots from veins, particularly in cases like deep vein thrombosis and pulmonary embolism.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use the AngioJet thrombectomy sets.
What are the FDA-cleared indications?
The device is indicated for use with an alternate component vendor for the low-pressure pump seal, specifically for mechanical thrombectomy in the venous system.
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.