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CentriMag Circulatory Support System - P170038

CentriMag Circulatory Support System

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: CentriMag Circulatory Support System
PMA Applicant: Abbott
Address: 6035 Stoneridge Drive, Pleasanton, CA 94588
Approval Date: December 6, 2019
Approval Letter: Approval order

What is it?  The CentriMag Circulatory Support System is a blood pump system intended to be used temporarily to help the heart pump blood in patients whose circulatory systems (heart and blood vessels) are not able to perform well enough on their own.  The CentriMag Circulatory Support System includes a blood pump, a motor that drives the pump, a console that controls the motor, a monitor, a flow probe, and flexible tubes (cannulae).

How does it work? The CentriMag Circulatory Support System pumps blood from the heart to either a blood vessel that supplies blood to most of the body (ascending aorta) or one that supplies blood to the lungs (main pulmonary artery), depending on how it is used. The pump is located outside of the patient’s body and is connected to the heart and the blood vessels using thin tubes (cannulae) inserted into a vein.  The cannulae are implanted in the patient surgically.

When is it used?  The CentriMag Circulatory Support System can be used to provide support for function of the left, right, or both heart ventricles after cardiac bypass surgery. The device is implanted surgically in the hospital. Patients with the device must stay in the hospital until it is removed, which may be up to 30 days.

What will it accomplish?  The CentriMag Circulatory Support System helps the heart pump blood to the body for up to 30 days. This allows the heart and the blood vessels to recover and get stronger after cardiac bypass surgery. Once they get stronger, the device’s cannulae attached to the heart and blood vessels are removed. If the heart does not recover enough of its function while on the device, the patient may need a different treatment.

In a clinical study, 69% (22/31) of the patients survived for at least 30 days after the device was removed.

When should it not be used?  The CentriMag System should not be used as a cardiotomy suction device. It should also not be used for patients who are unable or unwilling to use a blood thinner (anti-coagulant) like Heparin while they have the device.

Additional information (including warnings, precautions, and adverse events):