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iVAC2L™ - Percutaneous ventricular assist device

The transfemoral pulsatile pVAD

With a percutaneous femoral approach, iVAC2L can support with a pulsatile flow patients with impaired left ventricular function who require a mechanical circulatory support as bridge to decision or bridge to bridge (left ventricle assist device).1

The use of the iVAC2L is found to be effective in high risk percutaneous coronary intervention (PCI) procedures.2

Characteristics

  • ​Transfemoral 17 Fr percutaneous ventricle assist device (pVAD) system
  • A 17 Fr single lumen, bi-directional flow catheter, providing pulsatile support
  • Electrocardiography (ECG) or arterial pressure (AP) triggered counter pulsation
  • Driven and compatible with standard intra-aortic balloon pump (IABP) consoles
  • Inserted through the SoloPath Re-collapsible access system with an insertion profile of 13.5 Fr

Advantages for daily practice

  • Swift percutaneous approach in emergency situation2
  • Up to 1.5 l/min of additional cardiac output
  • Non-significant hemolysis, fHb < 6 µmol/l2
  • No additional cost for a console; compatible with a standard IABP console
  • Ease of use

 

The catheter is composed of an inlet tip, an integrated bi-directional valve and a connector for connection to the membrane pump.

General Specifications

Catheter size17 Fr (O.D. 5.9 mm) diameter
Catheter length 100 cm
Guidewire compatibilityMax. 0.038" (0.89 mm), min. length: 260 cm
Catheter material Nitinol
Valve/tipStainless steel (316L)
​Kit content​LV17 catheter
Membrane pump
Extra PTFE catheter inner tube
Extension tube
SoloPath Re-collapsible (SR1935) access system

Procedural Videos

 

Product Illustrations

Mechanism of action

​The mechanism of the iVAC2L is a patented bi-directional valve integrated in a 17 Fr single lumen and 100 cm long catheter. This catheter is connected to an extracorporeal 40 ml membrane pump. It is compatible with a standard IABP console and does not require dedicated hardware.

During the systolic phase of the heart, up to 1.5 l/min of blood is aspirated through the tip of the catheter from the left ventricle into the membrane pump.

During the diastolic phase of the heart, the bi-directional valve changes position blocking the via to the left ventricle and the blood can be given back directly into the ascending aorta (the aortic valve is closed)

The pulsatile synchronization ensures that the cardiac output is not impaired but enhanced.

Item Specifications

​iVAC2L - single pack

Item referenceSpacing – distal tip to bi-directional valve (mm)Catheter length (cm)
LV17-173100

 

 

 

 

 

 

 

 

References

​iVAC2L is a trademark of PulseCath b.v., The Netherlands

iVAC2L is manufactured by PulseCath b.v. and exclusively distributed by Terumo Europe NV in the following countries: France, Germany, Austria, Switzerland, Italy, Spain, Netherlands, Belgium.

 

1 Use of the device approved for up to 24h according to IFU of the iVAC2L product.
2 Application of a Pulsatile Catheter Pump in Left Ventricle Cardiac Assistance for up to 24 hours in high risk PCI Patients; An interim Clinical investigation Report; PulseCath October 2014.

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