UPDATED: FDA greenlights trial of Biotronik's MRI-safe pacemaker
|Biotronik is looking to get the FDA's approval for a line of MRI-safe pacemakers--courtesy of Biotronik|
The FDA approved a clinical trial of Biotronik's proMRI pacemaker, a device designed to operate without a hitch during an MRI. The company hopes to get the tech on the U.S. market, joining the growing number of companies developing devices that can be marketed with MRI compatability in mind.
Biotronik's goal during the large 245-person trial is to evaluate the device after exposure to MRIs to determine its viability as a safer alternative to traditional pacemakers, hoping to join companies such as Boston Scientific ($BSX), St. Jude Medical ($STJ) and Medtronic ($MDT), which already have MRI-safe devices in several global markets.
It's a risky move, though, spending money and resources on such a venture when the MRI-safe label could be meaningless--in a study last year, researchers found that traditional pacemakers might not be dangerous during an MRI after all. It's therefore only an assumption that the magnetic forces from an MRI have a negative effect on the devices.
"It's possible [traditional pacemakers] are safe, and that would be great," said Rex Richmond, VP of Marketing at Biotronik. "But if people want one they know will be safe, they'll go for it. That's why we're pressing forward."
Meanwhile, device manufacturers are churning the devices out around the world--some such pacemakers are Boston Scientific's Ingenio and Advantio, on the market in Europe and the U.S.; St. Jude's Accent, available in the U.S.; Medtronic's Advisa, released in Japan late last year, and Medtronic's earlier device, the Revo MRI SureScan, the first one approved by the FDA.
Because many patients who are implanted with pacemakers require regular MRIs, the market for these devices, if viable, would be a sizable one. Biotronik continues to tout the importance of MRI-compatible pacemakers, saying in a release that "they are essential to comprehensive medical care."
Editor's note: This story has been updated to include comments from Rex Richmond of Biotronik.
- here's the release