Safety Information

Impella® Left-Side Devices Indication & Safety Information (EU)

Device: Impella CP® with SmartAssist ®

Indications For Use

The Impella (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for the following indications, as well as others:

• The Impella is a circulatory support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction
• The Impella 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.
• Support during high risk percutaneous coronary intervention (PCI)
• Post PCI

Contraindications

• 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
• Ventricular septal defect (VSD) after myocardial infarction
• Anatomic conditions precluding insertion of the pump
• Other illnesses or therapy requirements precluding use of the pump

Possible Complications

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 vertricular perforation) 
• Positioning problems causing hemolysis 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 

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.

Device: Impella 5.5® with SmartAssist ®

Indications For Use

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 29 days for the following indications, as well as others:

• The Impella 5.5 with SmartAssist heart pump is a cardiovascular support system for patients with acutely reduced left ventricular function, e.g. low output syndrome, cardiogenic shock after acute myocardial infarction.
• The Impella 5.5 with SmartAssist heart pump is also a temporary support system for patients in need of circulatory support due to chronically reduced left ventricular function, e.g. for bridging patients with chronic heart failure to implantable assist device, heart transplantation, or myocardial recovery / stabilization.
• The Impella 5.5 with SmartAssist heart pump may also be used as a cardiovascular support system during cardiological interventions or heart surgery (e.g. coronary bypass surgery), particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome, or in cases of difficulties to wean from heart-lung machine support.

Contraindications

• 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

Possible Complications

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 vertricular perforation) 
• Positioning problems causing hemolysis 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 

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.

Device: Low Profile Companion Sheath Introducer

Indications For Use

The Impella Low Profile Companion Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
Contraindications:

Radial access is contraindicated if there is an abnormal Allen’s Test, radial pulse, or insufficient dual arterial supply.

Potential Complications

Potential complications include, but are not limited to: 

• air embolism
• infection
• hematoma
• bleeding
• perforation or laceration of the vessel wall
• thrombus formation
• pseudo aneurysm formation
• guide wire embolization
• vessel spasm
• risks normally associated with percutaneous diagnostic and/or interventional procedures.

Manufacturer (US):
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, Utah 84095 U.S.A.
1-801-253-1600
U.S.A. Customer Service 1-800-356-3748

European Representative:
Merit Medical Ireland Ltd. Parkmore Business Park West,
Galway, Ireland
European Customer Service 
+31 43 358 82 22
REF: X9PG700001/B

Manufactured for (US):
Abiomed, Inc.
22 Cherry Hill Drive
Danvers, MA 01923, USA
Voice: +1 978-646-1400
Email: [email protected]
Hotline: +1 800-422-8666

Manufactured for/ Importer (EU):
Abiomed Europe GmbH
Neuenhofer Weg 3
52074 Aachen, Germany
Voice: +49 (0) 2418860-0
Email: [email protected]
Hotline: 00800 0 22 466 33

Impella® Right-Sided Device Indication & Safety Information (EU)

Device:  Impella RP®

Indications for Use

The Impella RP System (percutaneous pump for right ventricular support) is intended for clinical use in cardiology, in cardiac surgery, and intensive care unit for up to 14 days for the following indications, as well as others:

• Acute or transient reduction of the right ventricular function (eg, postcardiotomy low output syndrome)
• Cardiogenic shock as a consequence of a posterior myocardial infarction with right ventricular heart failure
• Right heart support during coronary beating heart bypass surgery, especially for patients with a reduced preoperative cardiac output or for patients having a high risk of developing a postoperative low output syndrome for other reasons
• Right ventricular heart failure after implantation of a left ventricular assist device
• Therapy unresponsive arrhythmias with a reduction of right ventricular output
• Heart failure and/or cardiogenic shock as a consequence of refractory ventricular arrhythmias, as well as a consequence of sustained supraventricular arrhythmias, causing haemodynamic compromise.

Important Risk Information for Impella RP System

Contraindications

Arteriosclerosis, in particular calcification or other disorders of the pulmonary artery wall

• Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid valve or pulmonary valve
• Mural thrombus of the right atrium or vena cava
• Anatomic conditions precluding insertion of the pump
• Other illnesses or therapy requirements or precluding use of the pump
• Presence of a vena caval filter or caval interruption device, unless there is a clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter

Potential Complications

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 
• Infection and septicemia 
• Endocardiac injuries due to attachment of the pump to the inferior vena cava 
• 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 RP. For more information please see the Instructions for Use Manual.

Impella Connect® Indication & Safety Information (EU)

Intended Use

Impella Connect is intended to be used to enable remote patient monitoring by providing authorized users with passive viewing of the AIC’s display which includes information on alarms and data useful for troubleshooting and managing Impella devices to aid in patient management. Impella Connect transfers the video stream from the AIC (via the VGA output) and data stored by the AIC to a cloud-based remote viewing portal. Communication between the AIC and Impella Connect System is one-way (AIC to Impella Connect), and the streamed information is limited to Impella device operating parameters and alarm messages with no identifiable information. Impella Connect is powered directly by the AIC.

Precautions

• The Impella Connect System is not intended to provide real-time information for monitoring patient status on the AIC.
• During use of the Impella Connect, there will be a delay between when an image appears on the AIC screen and when it is displayed at a remote viewing location.
• The Impella Connect is not a source of patient alarms, nor is its use intended as a replacement for monitoring the AIC’s alarms.
• During use of Impella Connect, receipt of the displayed controller information is not confirmed by the AIC, nor is the delivery of the displayed AIC information to the authorized remote users guaranteed.
• Impella Connect is not designed for use during transport.
• When Impella Connect is configured to use the hospital’s secured Wi-Fi network, signal quality and strength is dependent on the hospital’s Wi-Fi.
• When Impella Connect is configured to use the hospital’s secured Wi-Fi network, connection may be lost in physical locations of low Wi-Fi signal.
• No modification of this equipment is permitted.
• Radiated and conducted electromagnetic interference can affect the performance of the Impella Connect, causing a temporary loss of connectivity. To clear interference, either increase the distance between system components and the EMI source or turn off the EMI source. Any electromagnetic interference related to Impella Connect System will have no impact on any of the AIC functional specifications.
• Portable and mobile RF communications equipment can affect medical electrical equipment.
• When in use, the Ethernet cables connecting Impella Connect System to the wall could represent a tripping hazard and should be placed where foot traffic is minimal.
• Keep excess cabling on the cable wrap when not needed.
• Disconnect, when in use, the Ethernet cables from the wall outlet before moving the AIC.
• Impella Connect is not interpretive.
• Impella Connect is not intended to control or interact with any drugs.

In addition to the information above, learn more about Abiomed and Impella. Visit www.abiomed.eu/important-safety-information