St. Jude Medical Tendril MRI LPA1200M, User Manual

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5. Was unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI
bore.
6. Had a prosthetic tricuspid heart valve.
7. Was currently participating in a clinical investigation that includes an active treatment arm.
8. Was allergic to dexamethasone sodium phosphate (DSP).
9. Was pregnant or planning to become pregnant during the duration of the study.
10. Had a life expectancy of less than 12 months due to any condition.
11. Had exclusion criteria required by local law (e.g., age).
12. Were unable to comply with the follow-up schedule.
Clinical Study Results
Patient Population
As of October 30, 2014, 920 patients were enrolled at 68 clinical sites in the Lead Safety Phase of
the MRI Study. The first Accent MRI
™ PM2218 pacemaker and Tendril MRI ™ LPA1200M leads
were implanted on March 30, 2012.
Of the 920 patients enrolled in the MRI Study, 918 were successfully implanted with an
Accent MRI pacemaker system. Two implants were unsuccessful due to an inability to implant the
Tendril MRI lead due to difficulty in obtaining access in one patient and a persistent left SVC in
the other patient. Both patients received a market-released pacemaker system, followed for 30
days for safety after the study implant attempt, and then were withdrawn from the study per
protocol.
Two hundred twenty-five (225) patients were enrolled in the MRI Phase of the MRI Study in the
United States. An additional 30 supplemental scans were performed in Australia, for a total of 255
patients who contributed data to the MRI Phase. The first MRI scan was performed on April 2,
2014.
The figure below displays the number of successful and unsuccessful implants in the MRI Study.