Medtronic Receives Panel Approval – Analyst Blog

Medtronic Inc. (MDT) recently received the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel’s approval for its study of a new pacemaker that can be used in a Magnetic Resonance Imaging (MRI) machine. The panel has voted unanimously in favor of the new pacemaker, REVO SureScan. Earlier, the panel had raised concerns over the small population size and missing data in the study.

 

It has been observed 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. More than 200,000 patients in the U.S. per year have to forego an MRI scan because they have a pacemaker. 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 study involved 464 patients implanted with REVO SureScan pacemakers at 42 centers around the world. The safety and effectiveness of REVO SureScan were evaluated in the MRI environment. There was missing data in the study with Medtronic, failing to provide a detailed follow-up on many patients who were enrolled.

 

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).

 

Presently, we are ‘Neutral’ on Medtronic.