Dandu et al., VAM. 2022.
Background
Acute lower extremity ischemia (ALEI) is a vascular emergency with a mortality rate of 15-20%2. Treatment is multifaceted and is typically aimed at restoring blood flow and can be performed surgically, endovascularly, or through a hybrid method.3
Methods
Single-center retrospective review of 27 ALEI patients treated with the JETi™ System. 89% of patients met criteria for Rutherford IIa or IIb classification. Patients were treated endovascularly or through a hybrid surgical approach. Adjunctive treatment included angioplasty, stenting and open thrombectomy.
Endpoints
Removal of over 50% of clot burden from target artery, restoration of inline flow. Indications, limb salvage, and major adverse events were reviewed.
Despite a challenging patient population, target thrombus was successfully removed in 85% of JETi™ cases with zero patient deaths at 30 days.
Target Thrombus Successfully Removed | JETi™ |
---|---|
JETi™ Alone | 26% (7/27) |
JETi™ + Adjunctive Procedures* | 59% (16/27) |
Overall (Includes JETi™ Alone and JETi™ + Adjunctive Procedures) | 85% (23/27) |
*Angioplasty, stenting, open thrombectomy.
MAT-2207738 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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Precautions
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