đź“‹ FDA Reference

angiojet dvx rheolytic thrombectomy catheter

Possis Medical

Summary: The AngioJet DVX Rheolytic Thrombectomy Catheter is a medical device used to remove thrombi (blood clots) from blood vessels. It is primarily used by interventional radiologists and vascular surgeons in hospital settings.

FDA Clearance Information

Pathway 510K
Decision Date April 28, 2005
Product Code QEZ
Device Class Class 2
Evidence 0 studies

The AngioJet DVX was cleared through the FDA 510(k) pathway on April 28, 2005. Manufactured by Possis Medical, it is classified as a Class 2 device under product code QEZ.

What It Is

The AngioJet DVX Rheolytic Thrombectomy Catheter is a specialized device designed to remove blood clots from veins and arteries. It operates by using high-pressure saline jets to break up and remove thrombi, restoring blood flow. This device is particularly useful in cases where anticoagulation therapy is insufficient or contraindicated.

Clinical Applications

This device is commonly used in interventional radiology and vascular surgery to treat patients with deep vein thrombosis (DVT) or other thrombotic conditions. It is often employed in hospital settings, particularly in catheterization labs or operating rooms, and is suitable for patients who require rapid clot removal to prevent complications such as pulmonary embolism.

Indications for Use

The AngioJet DVX is indicated for patients with venous thrombi, such as those with deep vein thrombosis. It is used to mechanically remove clots, especially when traditional treatments are not effective or feasible.

Practical Considerations

The catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard angiographic equipment. Clinicians should be trained in its use to ensure effective and safe thrombus removal.

Related Literature

The linked study is a prospective observational registry examining the peripheral use of the AngioJet Rheolytic Thrombectomy with mid-length catheters. While specific findings are not detailed, such studies typically assess the efficacy and safety of the device in real-world settings. Limitations may include the lack of a control group and potential selection bias.

Frequently Asked Questions

What is AngioJet DVX Rheolytic Thrombectomy Catheter used for?

It is used for the removal of blood clots from veins and arteries, particularly in cases of deep vein thrombosis.

What specialties typically use this device?

Interventional radiologists and vascular surgeons commonly use this device.

What are the FDA-cleared indications?

The device is indicated for the mechanical removal of thrombi in patients with venous thrombotic conditions.

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.

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