Clinical Data for JETi Lower Extremity Venous Thrombosis | Abbott
CARDIOVASCULAR
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JETi™ Hydrodynamic Thrombectomy System

Single-session treatment of lower extremity venous thrombosis using a novel thrombectomy device

Overview: Retrospective Pilot Study

Khalsa et al., JVIR. 2020.

Objective
To study the efficacy of the JETi™ Peripheral Thrombectomy System in treating acute venous thrombosis.

Methods
Retrospective review of 40 total procedures in 30 patients with acute lower extremity venous thrombosis (25 iliocaval, 20 iliofemoral and 15 femoropopliteal segments).

Primary Endpoints
Technical Success Rate defined as reestablishment of inline flow.

Additional Endpoints
Percent thrombus removal, total thrombolytic dose, total procedural time, overnight thrombolysis post procedure, ICU length of stay, total hospital length of stay, procedure related complications, mean symptom duration and venous segments treated.

Clinical Outcomes

JETi™ Peripheral Thrombectomy System achieved a 93% overall technical success rate with 77% of patients successfully treated in a single-session. Patients treated with JETi™ in a single-session required less TPA and shorter ICU stays compared to those treated with overnight CDT. 

  Single-Session JETi™ Thrombectomy
(n = 23/30)
Overall JETi™ Thrombectomy*
(n = 30/30)
Mean ICU Length of Stay 1.1 days 1.6 days
Mean TPA Dose 3.1 mg 7.8 mg
Mean Thrombus Removal 81.2% 74.0%

*Data includes 7 patients requiring overnight CDT.

Restoration of inline flow was successfully achieved in 77% of patients in a single session.

JETI Restoration of Inline Flow

Single-session restoration of flow was associated with shorter ICU stays and a 60% lower dose of TPA when compared with overnight CDT.

JETi Shorter ICU Stays and Lower TPA Data

Technical success was achieved in 93% of patients treated with the JETi™ Thrombectomy System.

JETi Technical Success Data for Lower Extremity Venous Thrombosis

Reference:

Khalsa et al., JVIR. 2020.

Important Safety Information
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IMPORTANT SAFETY INFORMATION

rx-only-logo  JETi™ All-In-One Peripheral Thrombectomy System


Indications

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.
 

Contraindications

The JETi™ AIO Peripheral Thrombectomy System is contraindicated for use in:

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


Warnings

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.

  • The JETi™ Peripheral Catheter, JETi™ AIO Suction Tubing, JETi™ AIO Non-Sterile Kit, and JETi™ 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™ AIO Peripheral 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™ Peripheral Catheter and JETi™ AIO Suction Tubing with the JETi™ AIO Peripheral SDU.
  • 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.
 

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

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