JETi™ Hydrodynamic Thrombectomy System

Peripheral Thrombectomy Device

The JETi™ Hydrodynamic Thrombectomy System is designed to remove both peripheral arterial thrombosis and peripheral venous thrombosis.1

The JETi™ Hydrodynamic Thrombectomy System leverages cutting-edge technology to treat both peripheral arterial and venous thrombus with a novel hydrodynamic design.Utilizing a uniquely positioned high-pressure saline jet, JETi™ is able to fragment clot within the safety of the catheter tipwhile reducing catheter clogs.1 With HyperPulse™ Fluid Delivery, JETi™ can also sub selectively infuse/deliver diagnostics or therapeutics intra-procedurally.1

Dual-action Design Enables Efficient Clot Removal2

Unique Designto Rapidly Remove Thrombus Burden2

  • Novel hydrodynamic design to aspirate and fragment clot while reducing catheter clogs1
  • High single-session treatment success rateto help reduce costly ICU length of stay4

Minimal Risk of Procedural Complication

  • Minimized risk of embolization and hemolysis5,6
  • Low profile 6F and 8F cathetersto help avoid large-bore access site complications8

Proven Performance

  • Unobstructed flow restored in 94.3% of the limbs in patients with acute iliocaval and iliofemoral venous thromboembolism3
  • Successful removal of targeted thrombus in 85% of acute and subacute lower limb ischemia cases9

References

  1. JETi™ Thrombectomy System Instructions for Use (IFU). Refer to IFU for additional information.
  2. Schubert, F. et al. Cardiovasc Intervent Radiol. 2022 Jan;45(1):112-120.
  3. Razavi et al. JVIR. 2021.
  4. Khalsa, B., et al. JVIR. 2020.
  5. Cournoyer-Rodrigue et al. JVIR. 2020 
  6. Moser, K et al. JAMA. 1994 Jan;271(3):223-225.
  7. Data on file at Abbott.
  8. Redfors, B., et al. JAMA Cardiology. 2017.
  9. Dandu, C., et al. VAM 2022.

MAT-2116428 v4.0

Important Safety Information
 

JETi™ Hydrodynamic Thrombectomy System

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Indications for Use

The JETi™ Hydrodynamic 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.
 

Contraindications

The JETi™ Hydrodynamic Thrombectomy System is contraindicated for use in:

  • Vessels smaller than 4 mm (0.16”)
  • Coronary, pulmonary, and neurovasculature


Warnings

  • The catheter, suction tubing, and pump set contents are supplied sterile using ethylene oxide (EO). Do not use if the expiration date has passed or the sterile barrier is damaged.
  • The catheter, suction tubing, non-sterile canister set, and pump set contents are for single patient use only. Dispose after use. Do not reuse, reprocess, modify, or resterilize. Reuse, reprocessing, modification, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, may result in patient injury, illness or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient.
  • The JETi™ Hydrodynamic Thrombectomy System is not approved for use with defibrillation. In the event shock must be delivered to the patient, remove the catheter and clear all connected system components from the patient before delivering shock.
  • Do not use a catheter that has been kinked or damaged.
  • Do not use a pump set if it does not prime.
  • Only use the JETi™ Catheter, JETI™ Pump Set, JETi™ Suction Tubing, and JETi™ Non-Sterible Canister Set with the JETi AIO Saline Drive Unit or the JETi™ Saline Drive Unit.
  • Do not mix contrast media in the saline bag.
  • When the catheter is exposed to the arterial system, it should be manipulated while under high-quality fluoroscopic observation.
  • In the event that the catheter becomes blocked or clogged with thrombus, remove and replace the device with a new device.
  • Do not use if package is opened or damaged.
  • To avoid risk of electric shock, the SDU must only be connected to mains power with a protective earth.
  • The power socket-outlet must be located near the device and must be easily accessible.
  • Do not modify or alter the device.
  • Do not step or stand on the base of the device.
  • Do not push or lean against the IV pole.


Precautions

  • 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.
  • Flow aspiration could be reduced by lower atmospheric pressure at higher altitude.
  • When delivering fluid through the catheter aspiration lumen, do not exceed the maximum recommended flow rate, per Table 1 below
     
Table 1. Catheter Fluid Delivery Flow Rate
FluidMaximum Recommended Fluid Delivery Flow Rate
Saline4.0 mL/s
60% Ionic Contrast Media1.8 mL/s


Potential Adverse Effects

Potential adverse events include, but are not limited to:

  • Acute closure
  • Aneurysm or pseudo aneurysm
  • Allergic reaction to contrast
  • Arrhythmia
  • Death
  • Embolism (air or device)
  • Embolization (thrombotic)
  • Emergency surgery
  • Access site pain, hemorrhage, or hematoma
  • Infection (systemic/sepsis)
  • Local infection (puncture site)
  • Minimal blood loss
  • Vessel dissection, perforation, or other injury
  • Vessel spasm
  • Thrombosis

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 v3.0