📊 Evidence-Based Reference
Possis AngioJet Rapid Thrombectomy Catheter System F105 Catheter Model 3030c LF140 Catheter Model 3040c Pump Set 3020p
Possis Medical
Summary: The Possis AngioJet Rapid Thrombectomy Catheter System is a mechanical thrombectomy device used primarily for venous thrombosis. Key evidence includes its application in central venous sinus thrombosis and acute ischemic stroke with carotid occlusion.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K960970 ↗
Decision Date ?
December 3, 1996
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA via the 510(k) pathway on December 3, 1996. It is manufactured by Possis Medical and classified as a Class 2 device under product code MCW.
What It Is
The Possis AngioJet Rapid Thrombectomy Catheter System is a mechanical thrombectomy device designed to remove thrombus from blood vessels. It operates using a high-pressure saline jet to create a vacuum effect, aspirating the thrombus. It is intended for use in venous thrombosis cases.
FDA-Cleared Indications
- Percutaneous removal of thrombus from peripheral blood vessels.
- Mechanical thrombectomy using catheter-directed saline jets and aspiration in appropriately sized peripheral vessels.
Clinical Applications
- Mechanical thrombectomy for selected lower-extremity deep vein thrombosis.
- Thrombectomy of thrombosed dialysis grafts or fistulas.
- Removal of thrombus from peripheral venous or arterial vessels when the treated vessel is compatible with the catheter size.
- Catheter-based clot removal as an alternative or adjunct to medication-based thrombolysis in selected peripheral vascular cases.
Reported off-label uses
- Catheter-based thrombectomy for pulmonary embolism.
- Treatment of cerebral venous sinus thrombosis.
- Use during endovascular treatment of acute ischemic stroke or carotid occlusion.
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.
Evidence Summary
The available literature includes two studies, published between 2001 and 2007, focusing on the device's use in central venous sinus thrombosis and acute ischemic stroke. Study types include case reports and retrospective analyses.
Reported Outcomes
Published studies report the device's effectiveness in removing thrombus in cases of central venous sinus thrombosis and acute ischemic stroke with carotid occlusion. The studies highlight its potential to restore blood flow in scenarios where traditional methods may fail.
Safety Profile
Reported complications include the risk of exacerbating preexisting cerebral hemorrhage, particularly in cases with parenchymal hemorrhage. The studies did not extensively detail other adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Practical Considerations
- The record lists F105 catheter model 3030C, LF140 catheter model 3040C, and pump set 3020P; catheter selection depends on vessel diameter, clot burden, access route, and anatomy.
- The system requires a compatible pump set, saline, and fluoroscopic or other appropriate imaging guidance. Operators should follow the current device labeling for setup, flow settings, and treatment limits.
- Use requires percutaneous vascular access, commonly through the femoral or other appropriate venous or arterial access site, depending on the target vessel.
- The record does not establish MRI safety. MRI compatibility should be confirmed in the current manufacturer labeling; retained or implanted components may require separate evaluation.
- Potential concerns include vessel injury, bleeding, distal embolization, hemolysis, arrhythmia when treating near the heart, contrast-related complications, and incomplete clot removal. Contraindications and warnings should be reviewed before use.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Possis AngioJet Rapid Thrombectomy Catheter System?
The device is indicated for mechanical thrombectomy in cases of venous thrombosis, particularly central venous sinus thrombosis and acute ischemic stroke with carotid occlusion.
What outcomes have been reported in clinical studies?
Studies report successful thrombus removal and restoration of blood flow in central venous sinus thrombosis and acute ischemic stroke cases.
What complications have been reported?
Reported complications include the potential for worsening cerebral hemorrhage in patients with preexisting parenchymal hemorrhage.
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.