Impella 5.5® with SmartAssist® Heart Pump
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.
Impella 5.5 with SmartAssist Experience Summary
Features to Improve Hemodynamic Support
Accessories and Ordering Information
Impella 5.5 SmartAssist Set
Part number: 1000482
• Impella Catheter
• Purge Cassette
• Introducer and Graft Locks
• 0.018” x 260cm placement guidewire
Automated Impella Controller™
Part number: 0042-0040-EU
Provides an interface for monitoring and controlling the function of all Impella catheters.
• 10.4” color display for easy viewing
• Mounts to Controller Cart (not shown) for transport within hospital
• 60 minutes of battery back-up power for mobile transport
Placement Wire
Part number: 0052-3005
Guidewire with a radiopaque, shapable tip used for placement of Impella catheter into left ventricle.
0.018 inch x 260 cm
Purge Cassette
Part Number: 5 Package 1000200
The purge cassette delivers rinsing fluid to the Impella catheter.
The purge fluid flows from the purge cassette through the catheter to the microaxial blood pump to prevent blood from entering the motor.
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Indications for Use EU
The Impella 5.5® with SmartAssist® 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 with SmartAssist 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 with SmartAssist 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.
The Impella 5.5® with SmartAssist® heart pump is contraindicated for the following situations:
• Mechanical aortic valves, severe aortic valvular stenosis
• 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
• Ventricular septal defect (VSD) after myocardial infarction
• Anatomic conditions precluding insertion of the pump
There are risks of complications with every procedure using a blood pump.
These include among others:
• Acute renal dysfunction
• Aortic valve injury
• Cardiogenic shock
• Cerebral Vascular Accident/Stroke
• Myocardial infarction
• Renal failure
• Thrombocytopenia
• Hemolysis
• Bleeding
• Limb Ischemia
• Immune reaction
• Embolism, thrombosis
• Cardiac or vascular injury (including ventricular perforation)
• Positioning problems causing haemolysis or reduced haemodynamic support
• 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
NOTE
*Only for use in ventricular pumps
**StatLock is a trademark of Becton, Dickinson and Company
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