|By Business Wire||
|July 8, 2014 09:35 AM EDT||
BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that the first device patients to undergo full-body magnetic resonance imaging (MRI) scans in the United States have been implanted with the BIOTRONIK DX System. The first investigational scan occurred on Monday, July 7, 2014 at St. Mary Medical Center in Langhorne, Pennsylvania.
The unique BIOTRONIK DX implantable cardioverter defibrillator (ICD) system is the first and only defibrillator system to provide physicians with the complete diagnostic capabilities of a dual-chamber ICD, including atrial sensing and advanced proven shock reduction algorithms, with only a single lead. BIOTRONIK introduced DX technology to the U.S. in 2013.
“In most cases, it’s difficult for electrophysiologists to accurately predict whether their patients will require diagnostic procedures like MRI in the future,” said Dr. Rafael E. Pena, FACC, The Arrhythmia Institute, Newtown, Pennsylvania, who performed the ICD implant on the first patient to undergo a full-body MRI scan at St. Mary Medical Center. “Implanting ICDs with the option for MRI allows me to expand their access to this technology when they need it.”
“Frequently, patients with defibrillators need diagnostic imaging with MRI, and until now the safety of MRI imaging in those patients was questioned,” said Thomas Crawford, MD, Assistant Professor, University of Michigan Health System, and a principal investigator of the ProMRI® study. “MRI Conditional defibrillators are a major advance in cardiac devices.”
The BIOTRONIK ProMRI® study consists of a series of ground-breaking MRI compatibility trials. Phase A resulted in FDA approval of Entovis pacemaker systems for MRI scans with an exclusion zone. Phase B expanded the trial for pacemakers with full-body scans, including cardiac and thoracic spinal scans, and is nearing completion. Now, Phase C incorporates Iforia ICD systems into the list of devices being investigated for full-body MRI scans, including the DX system.
These first U.S. ICD patients receiving full-body scans are among several hundred who are already included in the ongoing study. The Food and Drug Administration (FDA) approved the ProMRI® study expansion to full-body scans for Iforia ICD and DX device systems on May 21, 2014.
Until recently, patients with a pacemaker or ICD were denied MRI scans. The strong forces applied during an MRI scan could negatively affect both implanted device and patient, usually contraindicating MRIs for pacemaker and ICD patients. With its ProMRI® technology, BIOTRONIK has developed a solution to give all cardiac rhythm patients access to MRI scanning. Investigational full-body scans for DX systems are the next step in expanding U.S. patient access to MRIs.
The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject recruitment since March 2013.
One of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world’s first 4 F-compatible 200mm peripheral stent*; Orsiro, the industry’s first hybrid drug-eluting stent*; and the world’s first implantable cardioverter-defibrillators with ProMRI® technology*.
* Investigational Device: Limited by U.S. law to investigational use.
For more information, visit: www.biotronik.com