MRI Examination and CarboMedics Heart Valve Products

Frank G. Shellock, PhD. assessed the safety and effectiveness of Magnetic Resonance Imaging (MRI) examinations on patients with CarboMedics heart valve implants in an ex-vivo study [1]. All models of CarboMedics implantable products were tested, including mechanical heart valves, Mitroflow Aortic Pericardial Valve bioprostheses, the Carbo-Seal® valved conduit, and Annuloplasty repair rings. However, Dr. Shellock did not test every single size of each model. Rather, the largest and smallest sizes of each product were tested to bracket the masses and material quantities of the remaining sizes, providing a representational sample of the entire range.

The referenced study found no measurable deflection of the implants with minimal temperature changes and imaging artifacts. The study concluded that "…heart valve prostheses and annuloplasty rings that underwent evaluation will not present an additional hazard or risk to a patient undergoing an MR procedure using an MR system operating with a static magnetic field of 1.5- or 3.0-Tesla or less and under the conditions used for this evaluation." The study indicated that these devices should not disrupt the diagnostic use of MRI, unless the imaging area of interest is in the exact position of where the device is located.

References: 1. References: 1. Shellock, Frank G., Ph.D. Evaluation of Magnetic Resonance Safety for Heart Valve Prostheses and Annuloplasty Rings. Study commissioned by CarboMedics; November 4, 2002.

MRI Safety Report (PDF Format)