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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
510K
Number
K960970 ↗
Decision Date
December 3, 1996
Product Code
MCW
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.
Clinical Applications
Common clinical scenarios for this device include treatment of central venous sinus thrombosis and acute ischemic stroke with carotid artery occlusion. It is particularly useful in cases where traditional thrombolysis is contraindicated.
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.
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.