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.
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
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.
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.
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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.
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
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
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