In the past decade, the use of MRI scanners has skyrocketed. Because the machines are able to provide relatively detailed images of soft tissues, they are extremely valuable in diagnosing cancers, heart problems and even back pain. These machines use a powerful magnetic field, radio frequency pulses and a computer to produce pictures of internal body structures.
But MRIs have been off limits to patients with implanted heart pacemakers. That’s because the MRI’s magnetic field could wreak havoc on a pacemaker’s electronic circuitry. Or worse, some of the pacemaker’s metal components could heat up and literally cook parts of the heart.
But Medtronic of Canada Ltd. has obtained Health Canada’s approval to sell a new pacemaker that is compatible with MRIs. The device, more than a decade in the making, contains new circuitry and components that are resistant to the magnetic fields.
“This is a major technological breakthrough,” said Anne Gillis, a professor of medicine at the University of Calgary who was involved in the clinical trials.
The new pacemaker will likely cost several hundred dollars more than earlier models, which range in price from $2,000 to $5,000.
Other medical-equipment makers are also planning to introduce similar pacemakers.
An analyst who attended the Heart Rhythm Society meeting in San Francisco (May 4-7) believes that Medtronic (NYSE: MDT ) is likely charging $3,000 more for the Revo SureScan MR Conditional pacemaker than previous pacemakers. Physicians at the conference, however, believe that Medtronic may be making a mistake in pricing the device so high even though it leads the market in this device category, said David Lewis, a Morgan Stanley analyst, in a note to investors Monday.
Medtronic‘s Revo is the first implanted pacemaker that the U.S. Food and Drug Administration approved for use in the MR environment because it was able to meet certain conditions to ensure safety and effectiveness. It was approved in February. No other company has a similar device out in the market domestically, which gives the Fridley, Minnesota, company the edge.
Medtronic, in turn, has high hopes for the product. In a Feb. 22 earnings call, Bill Hawkins said the following: “We believe this product will help to draw share and alleviate pricing pressure [on pacemakers]. So, I’m fairly bullish that this is going to be a real big opportunity for us.”
But Lewis’s note said that while most clinicians at the HRS meeting considered Revo the most important product launch for the company, enthusiasm for the product was not consistent. Some felt it was nice to have as opposed to something essential. Lewis concluded that “Medtronic’s pricing strategy may be dampening enthusiasm for the product.”
However, company executives seemed to be happy with how Revo is performing, although they would not share details to confirm that sales were meeting internal projections. Lewis came away from the HRS meeting with the impression that Medtronic, which makes new innovative medical devices, has no plans to alter Revo’s pricing strategy currently.
All eyes will likely be on Medtronic at the end of May when the company reports its results for fiscal first-quarter 2012.
- Pacemaker upgrade allows for MRI scans (dispatch.com)
- The new wave of MRI-safe heart devices (scientificamerican.com)
- MRI-friendly pacemaker provides more options to heart patients (canada.com)
- Pacemaker patients gain access to MRIs (theglobeandmail.com)
- Baylor Hamilton Heart Hospital Implants First MRI-Safe Pacemaker in North Texas (prnewswire.com)