Levitronix of Waltham, Massachusetts, a company that specializes in magnetically levitated devices, has received approval from the FDA to begin sales of the CentriMag Right Ventricular Assist System. Just like other temporary ventricular assist devices, the CentriMag is intended for patients as a bridge to transplantation, or until a “long-term heart assist device can be implanted,” according to the FDA. Also according to the agency, the CentriMag can be implanted for up to 14 days to keep patients alive.
From the product page:
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.
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.
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.
FDA press release: FDA Approves Use of Temporary Pump to Assist Heart’s Right Side…
Product page: Levitronix® CentriMag® Blood Pumping System…
Images: Side top: CentriMag® Extracorporeal Blood Pumping System primary console and motor Side bottom: blood pump
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