JETi™ Hydrodynamic Thrombectomy System

Peripheral Thrombectomy Device


JETi Peripheral Thrombectomy Registry

The JETi Registry (JETi Peripheral Thrombectomy Registry NCT04370691) is an all-comers, prospective, single-arm, multicenter, post-market study designed to collect real-world data on the JETi Hydrodynamic Thrombectomy System (JETi™ System), a hydro-mechanical aspiration system intended to remove intravascular thrombus.

The JETi Registry will enroll approximately 280 all-comer patients at approximately 30 sites globally. Patients may be treated for either arterial or venous thrombosis in the peripheral vasculature and are followed for 1 year, with data collection at baseline, procedure, discharge, 30 days, and 1 year. Enrollment for the arterial cohort is complete with a total of 129 registered patients, and primary endpoint outcomes are available for these patients. Enrollment for the venous cohort is ongoing.

The primary endpoints for the arterial thrombosis cohort are clot removal grade (% of clot removal) for each treated vessel pre- to post-JETi™ system treatment and the composite rate of JETi™ System-related major adverse events, defined as device-related death, major amputation of the treated limb, or major bleeding, up to 30 days post-procedure. Descriptive endpoints include core lab assessed thrombo-aspiration in peripheral ischemia (TIPI) flow, ankle brachial index (ABI), Rutherford classification, and the SF-12 quality of life assessment.

Clinical Outcomes
After JETi™ system treatment and prior to any other adjunctive treatments or devices, 72.1% of treated vessels achieved 50% or more thrombus reduction with 96.1% of vessels at complete or near complete recanalization. After JETi™ System and other adjunctive treatments or devices, 94.0% of treated vessels achieved at least 50% thrombus reduction with all vessels at complete or near complete recanalization. There were 0 JETi™ System-related major adverse events or adverse events (CEC adjudicated), no device and procedure related deaths (CEC adjudicated), and a 0% re-thrombosis rate up to 30 days post-procedure. Most patients were treated in a single session (86.8% of patients) and few underwent catheter-directed thrombolysis (<15% of patients).


Pin, R. on behalf of the JETi Registry Investigators, Primary analysis of the novel JETi™ mechanical thrombectomy system for the treatment of arterial thrombosis. LINC, Leipzig, Germany 2024 May 28-31.

MAT-2406009 v1.0

Important Safety Information

JETi™ Hydrodynamic Thrombectomy System


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.


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

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


  • 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.


  • 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