(MDT) Medtronic Runs into FDA Trouble in Pacemaker Study

March 17th, 2010

Medtronic Inc. (MDT) has received several complaints from the U.S. Food and Drug Administration (FDA) regarding the company’s study of a new pacemaker that can be used in a Magnetic Resonance Imaging (MRI) machine. The FDA has raised concerns over the small population size and missing data in the study.

The study involved more than 500 patients with pacemakers, half of whom were randomly assigned to receive an MRI scan. However, Medtronic failed to provide a detailed follow-up on many patients who were enrolled in the study.

It is seen that patients implanted with pacemakers are generally discouraged from going through MRI scans as the radio waves could interfere with the functioning of their device. Medtronic’s REVO Surescan pacemaker claims to be the first device of its kind that can be safely used while undergoing such powerful scans. The FDA has decided to appoint a panel of external experts to find out whether the claims are justified.

MRI is one of the most widely used scanning technologies. Physicians use the technology to detect problems in the brain, heart and other organs.

Medtronic is one of the world’s leading medical technology companies, specializing in implantable and interventional therapy devices and products. The company’s main competitors include St. Jude Medical (STJ) and Boston Scientific Corp. (BSX).

Currently, we are ‘Neutral’ on Medtronic.

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