đź“Š Evidence-Based Reference
Possis AngioJet X-Stream Rheolytic Thrombectomy Catheter Model 103587-002
Possis Medical
Summary: The Possis AngioJet X-Stream is a rheolytic thrombectomy catheter used primarily for mechanical thrombectomy in venous systems. Key evidence highlights its efficacy in treating thromboembolic complications during peripheral endovascular procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K993564 ↗
Decision Date ?
April 28, 2000
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Possis AngioJet X-Stream was cleared by the FDA via the 510(k) pathway on April 28, 2000. It is manufactured by Possis Medical and classified as a Class II device.
What It Is
The Possis AngioJet X-Stream is a rheolytic thrombectomy catheter designed to remove thrombus from blood vessels. It operates by using high-velocity saline jets to create a vacuum that breaks up and removes clots, intended for use in venous thrombectomy procedures.
FDA-Cleared Indications
- Mechanical removal of thrombus from peripheral blood vessels.
- Use during percutaneous peripheral vascular procedures when thrombus removal is clinically indicated.
- The device is classified under FDA product code MCW for peripheral atherectomy/thrombectomy catheters.
Clinical Applications
- Percutaneous thrombectomy in peripheral venous vessels.
- Removal of thrombus associated with peripheral vascular occlusion.
- Thrombus removal during selected peripheral endovascular revascularization procedures.
- Treatment of thrombotic occlusion in peripheral vascular access when consistent with the device labeling and anatomy.
Reported off-label uses
- Thrombectomy for acute limb ischemia involving arterial vessels.
- Thrombectomy of occluded hemodialysis fistulas or grafts.
- Catheter-based treatment of pulmonary embolism.
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 literature includes a mix of RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2009 to 2016, providing insights into the device's application and outcomes.
Reported Outcomes
Published studies report the AngioJet X-Stream's effectiveness in treating thromboembolic complications, particularly in infrainguinal procedures and occluded dialysis fistulae. It has shown positive outcomes in restoring vessel patency and improving clinical symptoms.
Safety Profile
Reported complications include potential risks associated with mechanical thrombectomy, such as vessel injury and bleeding. However, the studies reviewed did not provide detailed safety data, indicating a need for further research.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and detailed safety data. Further research is needed to establish long-term outcomes and comprehensive safety profiles.
Practical Considerations
- The catheter must be used with the compatible AngioJet console, saline supply, and aspiration pathway specified in the device instructions for use.
- Vessel diameter, lesion length, access route, and thrombus burden must be assessed before treatment; the catheter is not suitable for every vessel or occlusion.
- Rheolytic thrombectomy can cause hemolysis and may produce hemoglobinuria; monitor the patient according to institutional protocol, particularly during extensive treatment.
- MRI safety should not be assumed from the 510(k) clearance. Confirm the exact model's current labeling and MRI conditions before an MRI examination.
- Use is subject to contraindications and warnings in the manufacturer’s instructions for use, including risks related to vessel injury, bleeding, perforation, distal embolization, and contrast or saline administration.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Possis AngioJet X-Stream?
The device is indicated for mechanical thrombectomy in venous systems, particularly in cases of acute limb ischemia and thromboembolic complications during peripheral endovascular procedures.
What outcomes have been reported in clinical studies?
Studies have reported effective thrombus removal and vessel patency restoration, particularly in infrainguinal thromboembolism and occluded dialysis fistulae.
What complications have been reported?
Reported complications include potential vessel injury and bleeding, though detailed safety data is limited in the reviewed studies.
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.