LAKE OSWEGO, Ore. -- (BUSINESS WIRE) -- BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved a significant expansion of its ongoing ProMRI® trial. The approval will allow patients enrolled in Phase C of the trial to receive full-body scans, and for the first time include patients with DX implantable cardioverter defibrillators (ICDs) in the study.
In 2011, BIOTRONIK received CE mark approval and became the first company in the world with an ICD approved for use in a magnetic resonance imaging (MRI) scanner. The ProMRI® study is the next step in making this technology widely available in the U.S.
The unique BIOTRONIK DX ICD system provides 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 in 2013 in the U.S., and it has been quickly adopted by electrophysiologists nationwide. Patients prefer implants with less hardware while physicians benefit from dual-chamber diagnostic data.
“With the DX system, I gain important diagnostic and therapeutic information. For my primary prevention patients with no dual-chamber pacing indication, the implant procedures are straightforward, and it makes sense to use as little hardware as possible,” said Harpreet S. Grewal, M.D., FACC, FHRS, at Richmond Cardiology Associates in Richmond, Virginia. “The potential to provide this therapy and have it approved for use in full-body MRI conditions adds clinical value.”
Phase C of the ProMRI® trial is the final phase in a series of ground-breaking MRI compatibility trials conducted by BIOTRONIK in rapid succession. Phase A and Phase B of the trial evaluated the safety of BIOTRONIK Entovis pacemaker systems during MRI scans. Phase A resulted in FDA approval on May 6, 2014 of Entovis systems for MRI scans with an exclusion zone. Phase B expanded the trial to evaluate the safety of Entovis pacemaker systems for full-body scans, including cardiac and thoracic spinal scans. Phase B is nearing completion and data will soon be submitted to the FDA.
“We are anxiously awaiting the day when this important diagnostic capability, up to now only available to pacemaker patients, can also benefit ICD patients,” said Kevin Mitchell, Vice President, Clinical Studies at BIOTRONIK, Inc. “BIOTRONIK is committed to extending its ProMRI® technology to as many patients as possible. We were the first company to offer ICD patients in the U.S. MRI access, and remain the only company that provides single-chamber pacemaker patients access to this diagnostic tool.”
Every year, about 200,000 patients in the U.S. are implanted with ICDs, and studies estimate that 50-75 percent of them will develop a clinical need for an MRI scan during their lifetime.1,2 MRI scans often provide improved diagnostic capabilities for certain diseases or conditions that cannot be adequately examined by X-ray, computerized tomography (CT) or ultrasound. The strong forces applied during an MRI scan can have a negative effect on both device and patient, and are usually contraindicated for pacemaker and ICD patients. With its ProMRI® technology, BIOTRONIK has developed a solution to enable all cardiac rhythm patients’ access to MRI scanning. ProMRI® technology is already used widely in Europe, including recent CE approval for MR Conditional full-body and 3.0 tesla scans with the Ilesto/Iforia ICD system.
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 5600 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
1 Morgan Stanley, ICD market, 1996–2009.
2 Roguin et al., Europace 2008, 10, 336-346.