Impella 5.5 with SmartAssist with purge cassette.

Impella 5.5® with SmartAssist®

The next generation - now available.

Simple Set-up, Confident Positioning, Maximum Unloading

The Impella 5.5® with SmartAssist® heart pump is now simpler to insert and easier to set-up and position while providing 5.5 L/min of forward flow and directly unloading the left ventricle. Use familiar surgical skills to insert it via the axillary artery or anterior aorta. Position confidently with the improved aortic placement signal, which also enables repositioning without imaging in the ICU. Sidearm, tubing, and catheter lock improvements facilitate patient management. New design for heparin-free purge with sodium hydrogencarboate (“bicarb”) purge solution can simplify anticoagulation management. Support patients for up to 29 days for indications including cardiogenic shock.

 

Heparin-Free Purge Solution for Impella 5.5® with SmartAssist® Heart Pump

Simply manage to the optimal systemic anticoagulation target for your patients. A purge solution with a bicarbonate additive simplifies patient anticoagulation management for physicians using the Impella 5.5 with SmartAssist heart pump, as the heparin administered by the Impella pump no longer needs to be accounted or calculated.

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Download the product brochure about the Impella 5.5 with SmartAssist Heart Pump.

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Impella 5.5 with SmartAssist Heart Pump comparison generation 1 and generation 2.

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Download the data sheet about Impella 5.5 with SmartAssist.

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Discover the Impella 5.5 with SmartAssist heart pump press release template.

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Overview Impella 5.5® With SmartAssist® Heart Pump - The Next Generation

New Features

  • New integrated purge filter unit improves patient management and mobility
  • Sodium hydrogencarbonat compatible luer – heparin-free purge alternatives
  • Connections – 1 luer connection for purgefluid and integrated purge tubing
  • Modular purge cassette for simplified line management

Ease of Insertion and Use

Enhanced deliverability and torque response with axillary artery or anterior aorta insertion using familiar surgical skills. New sodium hydrogencarbonate compatible luer for heparin-free purge alternative.

Confident Positioning

New always-locked catheter and new user-friendly 3-point fixation help stabilize position. Hemodynamic sensors provide an aortic placement signal for improved position detection and repositioning without imaging in the ICU.

Even More Simplified Set-up

Faster to set up with a new integrated purge filter unit that improves patient mobility, new integrated tubing for optimal purge line setup and management, and streamlined single fluid line to facilitate ICU management.

Full Support with Maximum Unloading

Provides up to 5.5 L/min of forward flow to perfuse coronary arteries and end organs, reducing the heart’s oxygen demand and workload. Directly unloads the left ventricle for up to 29 days for indications including support during cardiogenic shock.

 

Impella 5.5 with SmartAssist Heart Pump Direct Aortic Insertion

Learn more about the direct aortic insertion of the Impella 5.5 with SmartAssist heart pump.

 

Impella 5.5 with SmartAssist Heart Pump Axillary Insertion Animation

Learn more about the axillary insertion of the Impella 5.5 with SmartAssist heart pump.

Indications for Use EU

INDICATIONS FOR USE EU

The Impella 5.5 heart pump is an intracardiac pump for supporting the left ventricle. It is intended for clinical use in cardiology and in cardiac surgery for up to 29 days for the following
indications, as well as others:
• The Impella 5.5 is a cardiovascular support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction.
• The Impella 5.5 may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of
postoperative low output syndrome.

CONTRAINDICATIONS EU

Impella 5.5 with SmartAssist Heart Pump is contraindicated in the following situations:
• Mechanical aortic valves, severe aortic valvular stenosis or valvular regurgitation
• Hematological disorder causing fragility of the blood cells or hemolysis
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Aneurysm or necrotomy or severe anomaly of the ascending aorta and / or the aortic arch
• Mural thrombus in the left ventricle
• Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)
• Anatomic conditions precluding insertion of the pump
• Other illnesses or therapy requirements precluding use of the pump
• Severe peripheral arterial occlusion disease (PAOD) is a relative contraindication

POSSIBLE COMPLICATIONS EU

There are risks of complications with every procedure using a blood pump. These include among others:
· Hemolysis
· Bleeding
· Immune reaction
· Embolism, thrombosis
· Vascular injury through to angionecrotomy
· Positioning problems
· Infection and septicemia
· Dislocation of the pump
· Cardiovalvular injuries due to extreme movement of the suction cannula in relation to the cardiac valve or
as a result of attachment by suction of the pump to the valve system following incorrect positioning
· Endocardiac injuries as a result of attachment of the pump due to suction
· Pump failure, loss of pump components following a defect
· Patient dependency on the pump after use for support
In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices.
For more information please see the Instructions for Use Manuals.