Impella 5.5®

with SmartAssist®
A heart pump designed for surgeons with forward flow and intelligent patient management

Designed for Cardiac Surgeons

The Impella 5.5® with SmartAssist® Heart Pump is designed for surgeons who want to offer their patients complete left ventricular unloading with full systemic flow. Here you can find all information about the Impella 5.5 with SmartAssist heart pump. It is applied via the axillary artery or directly via the aorta using common surgical methods. In doing so, it results in direct unloading of the left ventricle by reducing ventricular work for a period of up to 30 days. The Impella 5.5 with SmartAssist heart pump is used, for example, in patients with cardiogenic shock.

Optimized Patient Management Through Further Developed Pump Key Figures

How can Impella 5.5 with SmartAssist support you in your daily clinical routine? The Impella 5.5 with SmartAssist's enhanced pump metrics make it easier to use the heart pump and, together with Impella Connect cloud-based remote monitoring, provide improved patient outcomes. Metrics facilitate patient management. For example, they assist in pump positioning and, thanks to special weaning algorithms, in the weaning phase, thus helping to optimize native cardiac recovery and outcome.

Improved Clinical Outcomes Using Impella 5.5 with SmartAssist Compared to Impella 5.0® in Patients with Cardiogenic Shock And Heart Failure

 

Clinical Evidence for Impella 5.5 With SmartAssist

A study published in the journal ASAIO examined outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cleveland Clinic, Hackensack University Medical Center/Hackensack Meridian Health and Cedars-Sinai Medical Center. Study authors and cardiac surgeons Ed Soltesz, MD, Mark Anderson, MD, and Danny Ramzy, MD, conclude that Impella 5.5 with SmartAssist is clinically appropriate for a number of challenging scenarios, including cardiogenic shock after AMI.2

  • 84%

    Survival rate2/

  • 76%

    The survivors regained their original cardiac function2/

Presentation by Prof. Reichenspurner: Impella 5.5 with SmartAssist - New Possibilities for Validation: The Impact Study

Impella 5.5 with SmartAssist - New Possibilities for Validation: The Impact Study

Prof. Reichenspurner from Hamburg presented the study design of the first pilot study of the IMpella-protected cArdiaC surgery Trial (IMPACT).

Presentation by Dr. Bernhardt at EACTS 2021: Extended support with pMCS makes bridge-to-scenarios more flexible

Extended Support With pMCS Makes Bridge-to-Scenarios More Flexible

Dr. Bernhardt, Hamburg, Germany, demonstrated the utility of Impella® 5.0 and 5.5 cardiac pumps for bridge-to-decision (BTD) in patients with unclear neurological prognosis.

Overview Impella 5.5® With SmartAssist® Heart Pump

The Impella 5.5 with SmartAssist heart pump is indicated for use in cardiogenic shock and is designed to unload the left ventricle and support systemic circulation.

  • Hemodynamic support up to 5.5
  • Placement via axillary or direct aortic access
  • Small motor diameter (18 Fr) & short motor facilitate placement
  • Fiber optic pressure sensor:
    • The placement signal is based on physiological pressure
    • The optical pressure sensor system provides high-tech pressure measurements for position control (for ventricular pumps)
      Shorter catheter (70 cm) for better mobility
 

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.

 

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 app on phone

Designed to Improve Outcomes with Real-Time Intelligence

Accessories

Impella 5.5 mit SmartAssist Kit
Automated Impella Controller™ (AIC)
Kit for Axillary Insertion
Placement Wire
Purge Cassette

Additional Information for Download

Download the step-by-step guide to Impella 5.5 with SmartAssist.

Download

Download the product brochure for Impella 5.5 with SmartAssist.

Download

Surgical case checklist using Impella 5.5 with SmartAssist.

Download

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 30 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
• Ventrikelseptumdefekt (VSD) nach Myokardinfarkt
• 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.

References

  1. Ramzy, D., et al. (2020). New Surgical Circulatory Support System Outcomes. ASAIO Journal. 

  2. Abiomed data available ES 2019 -129

  3. Only for pumps in the ventricle

IMP-3056