"It's Responsible For Him Still Being With Us."

For all that COVID-19 took, it opened doors to ingenious and creative care. Here's one example you might not know. 

"It's Responsible For Him Still Being With Us."
Healthy Heart | Apr. 27, 2021

For all that COVID-19 has taken from the world, it's also given humanity nearly endless opportunity to again demonstrate its resiliency, its ingenuity and the depths of its reservoirs to restore the human condition and how we care for each other.

That creativity has expressed itself not just in the form of rapid coronavirus testing that's affordable and accessible and now, available over the counter and without a prescription.

Just as it's not been limited to vaccine development aided by the lessons learned from previous SARS outbreaks.

COVID-19 touched every corner of life. There's so much more that might not be top of mind that's been crucial to not just extending, but also improving life throughout the pandemic.

The CentriMag Acute Circulatory Support System, for example. Let us tell you about it.

When Your Body Can't, CentriMag Can
For people living with heart failure, COVID-19 can make an already tenuous situation worse.

And when a person's heart and lungs become too weak to pump enough blood and oxygen that their body needs, CentriMag's extracorporeal membrane oxygenation (ECMO) became an important tool for life support during the COVID-19 pandemic. CentriMag does the work the body is too weak to do on its own.

As the pandemic surged in 2020, CentriMag provided doctors, patients, and loved-ones the most valuable commodity: Time.

Time to consider their options to improve their situations.

Time to choose the best course of care, including people who eventually required a left ventricular assist device (LVAD) or a heart transplant.

Time to open the window to recovery that otherwise might have closed.

"CentriMag Is Largely Responsible For My Friend Still Being With Us."
Seeing the difference CentriMag makes up close is striking to those who witness the work it can do. This letter from a frontline nurse, edited for length, attests to that.

"As some of you know, a dear friend who is only 41 and without comorbidities, was diagnosed with COVID-19. He was quarantining away from his wife and son in their basement when his wife heard odd breathing in the basement.

"When his wife found him, he was unresponsive. He was transported to the hospital and quickly intubated. He failed to adequately oxygenate due to the severity of his lung injury. Within 24 hours, the doctor placed him on CentriMag ECMO and he has been on full support since.

"Despite him continuing to be critically ill, his family and I are grateful that CentriMag was appropriately implemented quickly for COVID lung injury. I have worked as an RN/NP for 20 years. I have said every day, almost as a mantra, that he is in the best place possible because early initiation of CentriMag leads to better outcomes. I believe CentriMag is largely responsible for my friend still being with us.

"Please see my face and know that your efforts have personally mattered to me."

Still being with us. One of thousands with whom we can directly, personally relate.

Another opportunity for humanity to demonstrate its resiliency, its ingenuity and its ability to evolve through lessons learned. A chance to potentially open the door for CentriMag to help more people live longer, by providing the time necessary to keep the recovery window open.

Important Safety Information

CENTRIMAG

INDICATIONS, SAFETY AND WARNINGS

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
Temporary Expanded Indication: The FDA issued an enforcement policy guidance document in April 2020 allowing for FDA-cleared or approved cardiopulmonary bypass devices to be used in an ECMO circuit to treat patients who are experiencing acute respiratory failure and/or acute cardiopulmonary failure during the COVID-19 public health emergency. The CentriMag™ System including the CentriMag™ Blood Pump and PediMag™ Blood Pump are indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure.

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.

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.

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, cardiac arrhythmias (atrial or ventricular), thromboembolism (venous and arterial non-CNS), hypotension, hypertension, device malfunction or failure, psychiatric events, right heart failure, and death.

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™ 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.

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.

AMG PMP Adult Oxygenator
Temporary Expanded Indication:
A.M.G. MODULE PMP NO T.P. STERILE is indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure during the COVID-19 public health emergency.

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.”

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 PP Adult Oxygenator
Temporary Expanded Indication:
A.M.G. MODULE PP NO T.P. STERILE is indicated for use as part of an ECMO circuit for longer than 6 hours to treat patients with acute respiratory failure and/or acute cardiopulmonary failure during the COVID-19 public health emergency.

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".

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.

CentriMag™ Blood Pump
Indications [510(k) Clearance; 6-hour use]:
The CentriMag Circulatory Support System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).

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 Circulatory Support System console and motor to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc.).

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™ 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.

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.

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.