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Product Safety Advisories
Levitronix is committed to providing our customers with current safety information about our products. As part of our commitment, this section provides important information learned from clinical use and experience with our products. Below are the links to Levitronix product advisories and recalls:

⇒ Electromagnetic interference with the CentriMag System (July 2008)

General Product Information
Levitronix® utilizes state of the art technology to produce a new generation of blood pumps. Key features of the Levitronix CentriMag® Pump Design include:

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. back-up console & motor

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

Clinical Applications
Commercial Products
The Levitronix CentriMag Extracorporeal Blood Pumping System is FDA 510(k) cleared and available for commercial use 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.)

Clinical Trial - Investigational Device
The CentriMag® Ventricular Assist System is for investigational use only in the United States. Clinical trials are being conducted to evaluate the safety and effectiveness of the technology for use in the treatment of cardiogenic shock under an Investigational Device Exemption (IDE).

The clinical trials are designed to evaluate the CentriMag VAS for up to 14 days as a bridge to decision to treat one or both sides of the heart for patients in cardiogenic shock when it is uncertain whether the patient will recover, need a long-term VAD or need to undergo transplantation. The core system is attached to the patient using standard surgical technique. Figure 2 schematically illustrates how the investigational CentriMag® VAS may be used to support a patient.

Figure 2: CentriMag® VAS: Patient and Primary Console

Hemocompatibility
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® Blood Pump was compared with an industry standard. As seen below, the rise in plasma free hemoglobin over time associated with the CentriMag® Blood Pump 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)

Clinical Materials

CentriMag® users, or those interested in the clinical status of CentriMag® technology, may access key documents 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 .