Market Agreement Established for Next-Generation Software to Enable MRI-Guided, Catheter-Based Procedures

MRI Interventions (Irvine, CA, USA) and Siemens Healthcare (Erlangen, Germany) have signed an agreement to co-develop and market a next-generation software platform that will enable minimally invasive catheter-based procedures to be performed under the guidance of real-time magnetic resonance imaging (MRI).

Nearly all catheter-based interventions are currently done using fluoroscopy, an X-ray-based imaging technique. The software platform, to be used in combination with companion MRI-guided catheters, will enable procedures to be performed under MRI guidance rather than fluoroscopic guidance. This move to MRI-guided procedures is significant because MRI provides excellent visualization of soft tissue, MRI provides continuous three-dimensional (3D) visualization, and MRI scanning eliminates all radiation exposure for the patient and physician.

The new software platform will serve as the software component of MRI Interventions’ ClearTrace system. The full ClearTrace system, which is currently under development, is an integrated platform of software, reusable hardware, and disposable catheters designed to enable real-time, MRI-guided catheter interventions. MRI Interventions’ software will be a commercial successor to an innovative research software platform created by Siemens. Under a 2009 agreement between the companies, MRI Interventions and Siemens worked together closely on the development of the research platform, specifically for use in MRI-guided cardiac ablation procedures with MRI Interventions’ catheters.

MRI Interventions, under this new agreement, with cooperation and assistance from Siemens, will develop a commercial version of the research platform, for cardiac applications. Once the development work is completed, MRI Interventions will sell the software as its own product.

“We are pleased to continue our strong working relationship with MRI Interventions, a company that is helping to lead the industry into the emerging field of real-time MRI-guided procedures,” said Robert Krieg, VP of MR product innovation and definition at Siemens Healthcare. “We see tremendous potential to improve patient care by further expanding the therapeutic uses of MRI.”

MRI Interventions is an innovator in the field of real-time, MRI-guided therapeutic interventions. The company’s first product, the ClearPoint neurointervention system, is used commercially in the United States and Europe to enable MRI-guided, minimally invasive brain surgery. Similar to ClearTrace, the ClearPoint system is an integrated platform of software, reusable hardware, and disposable devices. The end result for the neurosurgeon is real-time, 3D visualization of the target neuroanatomy and surgical instruments with no radiation exposure for the patient or physician. MRI Interventions is developing these capabilities for catheter-based procedures outside of the brain with its ClearTrace system, with an initial focus on cardiac ablation procedures to treat arrhythmias.

“Effective evaluation and catheter-based treatment of patients suffering from complex cardiac arrhythmias have been impeded by poor visualization of patients’ cardiac tissue. Leading electrophysiology centers around the world are increasingly using MRI as the visualization platform to more accurately evaluate and stage their arrhythmia patients,” said Dr. Nassir Marrouche, associate professor of medicine and director of the electrophysiology lab at the University of Utah (Salt Lake City, USA) , and the executive director of the Comprehensive Arrhythmia Research & Management Center (CARMA). “As this trend gathers momentum, the next step is to move the cardiac ablation procedure into the MRI suite, with a system like ClearTrace. The CARMA team at the University of Utah has performed a large number of successful experimental studies using the ClearTrace system. Our experience with the system has been very good, and we are pleased this technology is moving forward to commercialization.”

“Interventional radiologists who have done research utilizing MRI guidance for catheter-based procedures are well aware of the many enticing benefits of moving from the fluoroscopic cath lab to the MRI suite,” said Dr. Aravind Arepally, section chief, vascular and interventional radiology, Piedmont Hospital (Atlanta, GA, USA). “It is exciting to hear that this capability is heading to a commercially-available product. This may not only provide an opportunity to improve certain current catheter-based fluoroscopic procedures but also may enable new procedures that are not currently feasible.”

“Siemens is the global market leader in MRI scanners. We have enjoyed an excellent working relationship with Siemens over the last few years and we are delighted to be taking this next step with them,” said Kimble Jenkins, CEO of MRI Interventions. “Extending the power of real-time MRI-guidance into catheter-based procedures represents another major opportunity in medicine. We believe that our ClearPoint system is transforming the way minimally invasive procedures are performed in the brain, and we hope to replicate this transformation for procedures in the body with our ClearTrace platform.”

The ClearTrace system is currently restricted for investigational use only and is not yet available for sale.

Related Links:
MRI Interventions
Siemens Healthcare