Impella 5.5® with SmartAssist® Heart Pump

Minimally Invasive Heart Pump Providing Full Support with Maximum Unloading

Overview

Impella 5.5® with SmartAssist® delivers full cardiac support with maximum unloading providing upto 5.5 L/min of forward flow, allowing the heart to rest and recover. It is a microaxial, surgically inserted heart pump that unloads the left ventricle, reduces ventricular work, and provides the circulatory support necessary to allow recovery and early assessment of residual myocardial function. It is designed for longer-duration support and enables ambulation to optimize recovery while using real-time SmartAssist intelligence.

The Impella 5.5 with SmartAssist is now simpler to insert and easier to set-up and allows to use familiar surgical skills for insertion 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. The new design for heparin-free purge with sodium hydrogencarbonate (“bicarb”) purge solution can simplify anticoagulation management in patients how do not tolerate heaprine in the purge solution.

Optimized Patient Management Through Further Developed Pump Key Figures

The enhanced pump metrics of the Impella 5.5 with SmartAssist facilitate the use of the heart pump and provide improved patient outcomes due to the cloud-based remote monitoring with Impella Connect® technology. Further developed pump metrics facilitate patient management. For example, they assist in pump positioning and in the weaning phase, thus helping to optimize native cardiac recovery and outcome.

Product Specifications

  • NEW Purge Filter Unit: Integrated purge filter unit improves patient management and mobility
  • NEW Catheter Lock: 1-step, always-locked design for ease of catheter repositioning and a pre-attached sterile sleeve
  • Cannula: Polyurethane coated nitinol with a 145-degree angle. Rigid 21 Fr cannula improves deliverability
  • Motor Housing: 18 Fr motor housing size allows for ease of vascular navigation around the innominate artery
  • Catheter Shaft: Polyurethane catheter with reinforced steel coil and triple internal lumens for pressure, purge and electrical signals
  • Position Sensor: Optical pressure sensor located immediately distal to the outlet, provides a pressure reading indicating aortic pressure only when both the outlet and sensor are located within the aorta
  • Blue Suture Hub: Designed to be inserted into a 10 mm graft with StatLock®** compatible suture pads, anticontamination sleeve, and catheter anchor 

Additional Resources

Discover What's New! Download the Product Comparision Guide of 1st Generation and 2nd Generation Products

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Download the datsheet for Impella 5.5 with SmartAssist.

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Heparin-Free Purge for Impella CP® with SmartAssist® and Impella 5.5® with SmartAssist® Heart Pumps

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Accessories and Ordering Information

Automated Impella® Controller(AIC)
Placement Wire
Purge Cassette

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

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.

NOTE

*Only for use in ventricular pumps

**StatLock is a trademark of Becton, Dickinson and Company

IMP-4908