Important Safety Information

High-Risk PCI
The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Cardiogenic Shock
The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0®, Impella 5.5® with SmartAssist® and Impella LD® Catheters, in conjunction with the Automated Impella Controller™ (collectively, "Impella® System Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, Impella 5.5 with SmartAssist and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

Important Risk Information For Impella Devices

Contraindications
The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD); Left ventricular rupture*; Cardiac tamponade*
 

* This condition is a contraindication for the cardiogenic shock indication only.

Potential Adverse Events
Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Cardiac or Vascular injury (including ventricular perforation).

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices.

Visit www.abiomed.com/products-and-services/impella and to learn more.

PMA APPROVED INDICATION
The Impella RP® System, Impella RP® with SmartAssist® and Impella RP Flex™ with SmartAssist® are indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.

Important Risk Information For Impella RP System and Impella RP with SmartAssist

Contraindications

The Impella RP System, Impella RP with SmartAssist and Impella RP Flex with SmartAssist are contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP devices. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the internal jugular or femoral vein to the right atrium that is large enough to accommodate a 22Fr catheter.

Potential Adverse Events
The potential adverse effects (eg, complications) associated with the use of the Impella RP System, Impella RP with SmartAssist and Impella RP Flex with SmartAssist: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Cardiac or Vascular injury (including ventricular perforation), Venous thrombosis, Ventricular fibrillation and/or tachycardia.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP, Impella RP with SmartAssist and Impella RP Flex with SmartAssist.

INTENDED USE
Impella Connect is intended to be used to enable remote viewing of the AIC’s user interface by clinicians and by trained Abiomed personnel who assist clinicians with troubleshooting AIC alarms or other issues. Impella Connect transfers the video stream from the AIC (via the VGA output) to a cloud-based remote viewing portal. Communication between the AIC and Impella Connect is one-way (AIC to Impella Connect), and the streamed video is limited to Impella device operating parameters and alarm messages with no patient identifiable information. Impella Connect is powered directly by the AIC.

PRECAUTIONS

The Impella Connect 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 the Impella Connect will have no impact on any of the AIC functional specifications.

Portable and mobile RF communications equipment can affect medical electrical equipment.

During use, no USB devices should be inserted.

When in use, the Ethernet cables connecting the Impella Connect 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.

INDICATIONS FOR USE
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.

INTENDED USERS
The OXY-1 System must be operated and/or monitored by users with specialized training in extracorporeal circulation therapy. These users include perfusionists, extracorporeal circulation specialists, ICU nurses with specialized extracorporeal circulation training, cardiothoracic surgeons, intensivists, and others with specialized training and experience. Users are required to be knowledgeable and experienced in methods that require cardiopulmonary bypass and mechanical circulatory support.

Utilization of the Abiomed Breethe OXY-1 System requires clinical judgment for patient risks vs benefits in all circumstances and requires specialized training in the use of cardiopulmonary bypass systems for safe operation under the direct supervision of a qualified physician. This is a prescription-only device.

Important Risk Information For Abiomed Breethe OXY-1 System

Contraindications
Use of the OXY-1 System for any other purpose beyond its indicated use is the responsibility of the user.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with the Abiomed Breethe OXY-1 System.