Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
CentriMag™ Circulatory Support System Indications [PMA Approval; 30-day use]: Temporary circulatory support for up to 30 days for one or both sides of the heart to treat post-cardiotomy patients who fail to wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient’s heart will recover or whether the patient will need alternative, longer-term therapy.
CentriMag Circulatory Support System Contraindications [PMA Approval; 30-day use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
CentriMag Circulatory Support System Adverse Events [PMA Approval; 30-day use]: Adverse events that may be associated with mechanical circulatory support can include, but are not limited to, the following: bleeding on device support, hemolysis, infection, renal failure/dysfunction/complication, respiratory dysfunction, hepatic dysfunction, cardia arrhythmias (atrial or ventricular), thromboembolism (venous and arterial non-CNS), hypotension, hypertension, device malfunction or failure, psychiatric events, right heart failure, and death.
CentriMag RVAS Indications [Humanitarian Exemption Device (HDE) Approval; 30-day use]: The CentriMag Circulatory Support System is intended to provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure.
CentriMag RVAS Contraindications [Humanitarian Exemption Device (HDE) Approval; 30-day use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
Humanitarian Device Statement: Caution: Humanitarian Device. The CentriMag Circulatory Support System is authorized by Federal Law for temporary circulatory support for up to 30 days for patients in cardiogenic shock due to right ventricular failure. The effectiveness of this device for this use has not been demonstrated.
CentriMag™ Blood Pump with CentriMag Acute Circulatory Support System for ECMO Indication [ECMO, 510(k) Clearance; >6-hour use]: The CentriMag™ Blood Pump for use with CentriMag Acute Circulatory Support System (Motor, Monitor, Console, and Flow Probes) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation (ECMO) circuit. ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients’ blood for adult patients with acute respiratory failure and/or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.
CentriMag Blood Pump with CentriMag Acute Circulatory Support System for ECMO Contraindications [ECMO, 510(k) Clearance; >6-hour use]: The CentriMag System is contraindicated for use as a cardiotomy suction device. The System is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
CentriMag Blood Pump with CentriMag™ Acute Circulatory Support System for ECMO Adverse Events [ECMO, 510(k) Clearance; >6-hour use]: Potential adverse events associated with the use of extracorporeal membrane oxygenation include, but are not limited to the following: Death, Mechanical Failures/Dysfunction, Bleeding (including Cardiac Tamponade), Hemolysis (including Hemoglobinuria, Anemia, Hyperbilirubinemia), Neurologic Dysfunction (including Stroke, Seizures), Cardiac Dysfunction (including Myocardial Infarction, Arrythmias, Right/Left Heart Failure), Hypertension, Hypotension, Vascular (including Air Embolism, Thromboembolism (venous/arterial), Limb Ischemia, Vascular Damage) Pulmonary Dysfunction (including Pulmonary Embolism, Respiratory Failure), Renal Dysfunction, Cardiogenic Shock, Hypovolemia, Hypervolemia, Hepatic Dysfunction, Coagulation Disorders (including Thrombocytopenia, DIC), Infection (including Wound Dehiscence), Metabolic/Respiratory Acidosis, Psychiatric Disorder.
CentriMag Circulatory Support System Indications [510(k) Clearance; 6-hour use]: The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient’s blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
CentriMag Circulatory Support System Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
PediMag™ Blood Pump Indications for Use [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is indicated for use with the CentriMag™ Console and Motor. It is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient’s blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
PediMag Blood Pump Contraindications [510(k) Clearance; 6-hour use]: The PediMag Blood Pump is contraindicated for use as a cardiotomy suction device. The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
CentriMag™ Pre-connected Pack Indications for Use [510(k) Clearance; 6-hour use]: The CentriMag Pre-connected Pack is indicated for use with the CentriMag Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
CentriMag Pre-connected Pack Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Acute Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for adult patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative.
CentriMag Pre-connected Pack Adverse Events [510(k) Clearance; 6-hour use]: Potential adverse events associated with the use of any extracorporeal circuit include, but are not limited to the following: Death, Respiratory Failure, Cardiac Arrhythmias, Right Heart Failure, Left Heart Failure, Thrombocytopenia, Hyper anticoagulation, Therapeutic Management Hypo anticoagulation, Exsanguination, Hyper anticoagulation Bleeding, Vascular Access Sites, Phrenic Nerve Damage and Diaphragm Paralysis, Vagus Nerve Damage and Larynx Muscle Dysfunction, Pneumothorax, Renal Failure/Dysfunction, Neurologic Dysfunction, Hemolysis, Hepatic Dysfunction, Hypotension, Cardiac Tamponade, Pericardial Effusion, Wound Dehiscence, Psychiatric Episode, Myocardial Infarction, Hyperthermia, Hypothermia, Anoxia, Hypercarbia
CentriMag Drainage (Venous) Cannula Kit Indications for Use [510(k) Clearance; 6-hour use]: The CentriMag Drainage (Venous) Cannula is indicated for use with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
CentriMag Drainage (Venous) Cannula Kit Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative. The CentriMag Drainage (Venous) Cannula is not intended for peripheral cannulation.
CentriMag Return (Arterial) Cannula Kit Indications for Use [510(k) Clearance; 6-hour use]: The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
CentriMag Return (Arterial) Cannula Kit Contraindications [510(k) Clearance; 6-hour use]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device. The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative. The CentriMag Return (Arterial) Cannula is not intended for peripheral cannulation.
AMG PMP Adult Oxygenator Indications [510(k) Clearance; 6-hour use]: The AMG MODULE PMP NO T.P. STERILE is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The AMG MODULE PMP NO T.P. STERILE is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. Contact with blood for a longer period of time is unadvisable. AMG MODULE PMP NO T.P. STERILE is an adult oxygenator. The AMG MODULE PMP NO T.P. STERILE should be used in combination with medical devices listed in section “Medical devices for use with the AMG MODULE PMP NO T.P. STERILE.”
AMG PMP Adult Oxygenator Contraindications [510(k) Clearance; 6-hour use]: This device used for any other purposes than for the indicated intended use is the responsibility of the user. See Instructions for Use.
AMG PMP Pediatric Oxygenator Indications [510(k) Clearance; 6-hour use]: The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for 6 hours or less with a maximum blood flow rate of 4 liters/minute.
AMG PMP Pediatric Oxygenator Contraindications [510(k) Clearance; 6-hour use]: No contraindications are known if the device is used for the purpose described and in accordance with the stated operating conditions. Do not use the device for any purpose other than indicated.
AMG PMP Infant Oxygenator Indications [510(k) Clearance; 6-hour use]: The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for 6 hours or less with a maximum blood flow rate of 1.5 liters/minute.
AMG PMP Infant Oxygenator Contraindications [510(k) Clearance; 6-hour use]: No contraindications are known if the device is used for the purpose described and in accordance with the stated operating conditions. Do not use the device for any purpose other than indicated.
AMG PP Adult Oxygenator Indications [510(k) Clearance; 6-hour use]: The A.M.G. MODULE PP NO T.P. STERILE is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The A.M.G. MODULE PP NO T.P. STERILE is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. Contact with blood for a longer period of time is unadvisable. A.M.G. MODULE PP NO T.P. STERILE is an adult oxygenator. The A.M.G. MODULE PP NO T.P. STERILE should be used in combination with medical devices listed in section “Medical devices for use with the A.M.G. MODULE PP NO T.P. STERILE.”
AMG PP Adult Oxygenator Contraindications [510(k) Clearance; 6-hour use]: Do not use the device for any purpose other than indicated. This device used for any other purposes than for the indicated intended use is the responsibility of the user. Relative contraindications to CPB procedures applies.
* PMA approval for 30-day use of CentriMag System components include: CentriMag Pump, CentriMag Console, CentriMag Motor, Mag Monitor, Flow Probe, and CentriMag Drainage Cannula and CentriMag Return Cannula. Optional accessories include: CentriMag System Cart, CentriMag System Transporter and Pressure Transducer. PMA approval for 30-day use of CentriMag System excludes: PediMag Blood Pump and any other pediatric components or accessories.
** ECMO clearance for >6-hour use is indicated for the CentriMag Blood Pump to be used with: CentriMag Console, CentriMag Motor, Mag Monitor, and Flow Probe. ECMO clearance for the CentriMag Blood Pump is for adult use only and excludes: CentriMag Drainage Cannula and CentriMag Return Cannula, PediMag Blood Pump and any other pediatric components or accessories.
*** AMG PMP Adult, Pediatric, Infant Oxygenators and Oxygenator Holder are manufactured by Eurosets s.r.l. and distributed by Abbott.
**** AMG PP Adult Oxygenator and Oxygenator Holder are manufactured by Eurosets s.r.l. and distributed by Abbott.
MAT-2006915 v6.0
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.
CardioMEMS HF System Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.
CardioMEMS HF System Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolization, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.
myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgement that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.
MAT-2006766 v6.0
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
HeartMate 3™ LVAS Indications: The HeartMate 3™ Left Ventricular Assist System is indicated for providing short and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.
HeartMate II™ LVAS Indications: The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.
HeartMate 3™ and HeartMate II™ LVAS Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.
HeartMate 3™ and HeartMate II™ LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System are listed below: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS), thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) and possible pump thrombosis.
MAT-2207924 v1.0
MAT-2100151 v3.0
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