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"Committed to delivering superior blood pumping systems for patients in heart failure and to providing the highest quality service and support to our customers."

General Product Information
Levitronix® utilizes state of the art technology to produce a new generation of blood pumps that provide hemodynamic support with minimal blood trauma. Unlike conventional devices, the Levitronix CentriMag® blood pump does not contain seals or bearings which are components known to cause hemolysis and promote thrombus formation. Similarly, Levitronix pumps do not contain flexing sacs, diaphragms, or valves, which may degrade and fail thereby limiting the potential duration of use. By eliminating the bearings and avoiding flexing components, the CentriMag® VAS is designed for longer life and reliability and to ideally reduce the incidence of device-related adverse effects.

Levitronix® CentriMag® Blood Pumping System
The Levitronix® CentriMag® Blood Pumping System is comprised of the following key elements (Figure 1):

1. a single-use blood pump
2. primary console & motor
3. a back-up console & motor

The system is designed to provide mechanical circulatory support for up to 30 days for patients suffering from severe, acute potentially reversible cardiac failure.

Figure 1: CentriMag® Extracorporeal Blood Pumping System: Primary Console and motor (left) and blood pump (right)

Clinical Application
The CentriMag® Blood Pumping System is designed to provide hemodynamic support for patients suffering from cardiogenic shock. The core system is attached to the patient using standard surgical technique. Figure 2 schematically illustrates how the CentriMag® Blood Pumping System may be used to support a patient.

Figure 2: CentriMag® VAS: Patient and Primary Console

Hemocompatibility
Blood cell damage during circulatory support may occur for a variety of reasons. Most commercially available devices contain bearings, which, when rotated cause friction. This friction leads to heat which in turn causes thermal damage to the cells. Likewise, uneven wear of the bearings, coupled with surface degradation, can directly damage the cellular elements. Blood cells may also be destroyed by high shear forces associated with rotation of the impeller blades and rotating seals. The end result is red cell destruction and platelet activation that can lead to thrombus deposition.

The only moving component within the pump is the impeller, which is levitated and rotated within the pump chamber in a contact-free manner. The centrifugal pump design permits rotation of the impeller at lower speeds (RPM) to achieve desired flows compared to other designs such as axial flow pumps. Rotating the impeller at lower speeds is less traumatic to the blood.

Red blood cell damage is referred to as hemolysis. A typical measure of hemolysis is the plasma free hemoglobin level. Hemoglobin normally resides within the red blood cell and is only seen in plasma if the cells have been destroyed. Thus, rising levels of plasma free hemoglobin indicate ongoing hemolysis.

The degree of hemolysis associated with the Levitronix® CentriMag® Ventricular Assist Device was compared with the industry standard. As seen below, the rise in plasma free hemoglobin over time associated with the CentriMag® Ventricular Assist Device was approximately half that associated with the industry standard. The lower plasma free hemoglobin levels indicate lower hemolysis.

Figure 3: Average Plasma Free Hemoglobin (mg/dL) 5 Lpm, 500 mmHg, (n=4 Industry Standard, 12 CentriMag® Blood Pumps, 4 Static Samples)

Commercial Status

The CentriMag® Ventricular Assist System is commercially available throughout Europe and countries that recognize the CE Mark. The system was developed for use as an extracorporeal ventricular assist device to support patients in severe, potentially reversible ventricular failure for periods of up to 30 days. The system is also designed and approved for use for Extracorporeal Life Support including ECMO.

CentriMag® users may access key the download section by logging into the Information for Clinical Users area of our website. This section requires a User ID and Password. To request a User ID and Password, you may email Levitronix at medicalsupport@levitronix.com.