Razavi et al., JVIR 2021.
Background
Catheter directed thrombolytics (CDT) often require prolonged exposure to thrombolytic agents which can increase bleed risk. CDT typically requires inpatient care making the treatment inappropriate for outpatient settings.
Objective
To investigate the short-term results of single-session treatment of iliocaval and iliofemoral venous thrombosis using the JETi™ Peripheral Thrombectomy System and evaluate potential for treatment on an outpatient basis.
Methods
Prospective pilot study of 47 patients (53 limbs) who presented with symptomatic iliocaval or iliofemoral venous thromboembolism and subsequently underwent percutaneous mechanical thrombectomy with the intention to treat in a single-session. Obstructive lesions were treated with adjunctive therapy, including balloon angioplasty and stenting, as needed.
Endpoints
Reestablishment of unobstructed flow in a single-session, freedom from major adverse events (MAE), improvement in the clot burden utilizing the VRI scoring system and device-related adverse events.
Overall, single-session unobstructed flow was reestablished in 89% of limbs with no major adverse events through 30 days. Including patients requiring requiring catheter directed thrombolytics (CDT), restoration of flow was successfully achieved in 94% of treated segments.
Segment | Flow Restoration: JETi™ Alone | Flow Restoration: JETi™ + Stent* |
---|---|---|
Iliocaval | 86% (12/14) | 100% (14/14) |
Iliofemoral | 75% (27/36) | 92% (33/36) |
Femoropopliteal | 100% (3/3) | N/A |
*Data includes patients who underwent overnight CDT.
Razavi et al., JVIR. 2021.
MAT-2201502 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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