04.08.15
The U.S. Food and Drug Administration (FDA) has approved German cardiovascular device company Biotronik SE & Co. KG’s ProMRI Eluna pacemaker system. The company’s ProMRI technology allows patients to undergo full-body magnetic resonance imaging (MRI) scans with both single-chamber and dual-chamber Eluna pacemakers when implanted with Setrox pacing leads.
Until now, patients with single-chamber pacemakers have not been able to access cardiac or thoracic MRI scans. Biotronik officials claim their firm is the only company in the United States with a “complete portfolio of pacemakers”.
approved for use with all 1.5 T MRI scans.
Magnetic resonance imaging improves diagnostic capabilities for many medical conditions such as chronic neck or lower back pain, soft-tissue masses and stroke symptoms that cannot be adequately examined by X-ray or computerized tomography.
“Due to safety concerns, most pacemakers are currently not approved for use in the MRI environment, limiting patients’ treatment options,” said Theofanie Mela, M.D., electrophysiologist at Massachusetts General Hospital in Boston, Mass., and investigator for the Biotronik ProMRI study. “MR conditional systems are necessary, and giving patients better access to diagnostic options will allow for better treatment.”
There are more than 6.5 million pacemaker patients worldwide, according to figures cited by the company, with an additional million patients receiving new implants each year. Until recently, patients with a pacemaker or implantable cardioverter defibrillator (ICD) were denied MRI scans due to concern that the strong magnetic fields and radio waves created by an MRI scanner could have a negative effect on both the implanted device and the patient.
“We want every pacemaker patient to know that they can access MRI scans with our tested and approved systems,” said Paul Woodstock, Biotronik’s executive vice president of sales and marketing. “Biotronik’s latest device and ProMRI technology ensure that patients—and their physicians—will have the best diagnostic options available.”
The company recently launched a new series of single- and dual-chamber ICDs and cardiac resynchronization therapy defibrillators.
Until now, patients with single-chamber pacemakers have not been able to access cardiac or thoracic MRI scans. Biotronik officials claim their firm is the only company in the United States with a “complete portfolio of pacemakers”.
approved for use with all 1.5 T MRI scans.
Magnetic resonance imaging improves diagnostic capabilities for many medical conditions such as chronic neck or lower back pain, soft-tissue masses and stroke symptoms that cannot be adequately examined by X-ray or computerized tomography.
“Due to safety concerns, most pacemakers are currently not approved for use in the MRI environment, limiting patients’ treatment options,” said Theofanie Mela, M.D., electrophysiologist at Massachusetts General Hospital in Boston, Mass., and investigator for the Biotronik ProMRI study. “MR conditional systems are necessary, and giving patients better access to diagnostic options will allow for better treatment.”
There are more than 6.5 million pacemaker patients worldwide, according to figures cited by the company, with an additional million patients receiving new implants each year. Until recently, patients with a pacemaker or implantable cardioverter defibrillator (ICD) were denied MRI scans due to concern that the strong magnetic fields and radio waves created by an MRI scanner could have a negative effect on both the implanted device and the patient.
“We want every pacemaker patient to know that they can access MRI scans with our tested and approved systems,” said Paul Woodstock, Biotronik’s executive vice president of sales and marketing. “Biotronik’s latest device and ProMRI technology ensure that patients—and their physicians—will have the best diagnostic options available.”
The company recently launched a new series of single- and dual-chamber ICDs and cardiac resynchronization therapy defibrillators.