Cournoyer-Rodrigue et al., JVIR. 2019.
Background
Mechanical and pharmacomechanical based thrombectomy may improve clinical outcomes, reduce concomitant CDT and lessen need for intensive care unit stays compared to anticoagulation alone.
Objective
To evaluate the safety and efficacy of JETi™ Thrombectomy System in treating acute venous thrombosis.
Method
Retrospective evaluation of 18 consecutive patients with 21 instances of acute venous thrombosis in JETi™ Thrombectomy System new user facility.
Primary Endpoints
Technical Success Rate (restoration of antegrade flow with or without additional treatment of an underlying obstructive lesion) and Procedural Success Rate (technical success with or without the addition of overnight CDT).
The JETi™ Peripheral Thrombectomy System achieved a 100% procedural success rate in 18 consecutive patients with a wide variety of target treatment vessels and had ZERO reports of blood transfusions, hypotension or hemolysis..
Procedural Success Rate | Single-Session Clot Reduction | Overall Clot Reduction (Single-Session + Overnight CDT) |
|
---|---|---|---|
Iliofemoral Vein (n=9) | 100% | 81% | 96% |
Axillosubclavian Vein (n=10) | 100% | 100% | 100% |
Portal Vein (n=2) | 100% | 100% | 100% |
*5 patients required overnight CDT.
Cournoyer-Rodrigue et al., JVIR. 2019.
MAT-2205000 v1.0
The JETi™ AIO Peripheral Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
The JETi™ AIO Peripheral Thrombectomy System is contraindicated for use in:
The JETi™ Peripheral Catheter, JETi™ AIO Suction Tubing, and JETi™ Pump Set contents are supplied sterile using EO. Do not use if the expiration date has passed or the sterile barrier is damaged.
Physicians must read and understand the Instructions for Use (IFU) prior to using the device. The device must be used by physicians skilled in percutaneous, intravascular techniques in a fully equipped catheterization laboratory.
Potential adverse events include, but are not limited to:
JETi™ is a trademark of Walk Vascular. Walk Vascular is a subsidiary of the Abbott Group of Companies.
Manufactured by Walk Vascular LLC 17171 Daimler Street, Irvine CA, 92614 USA
MAT-2116195 v1.0
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