Siemens, MRI Interventions to Develop Software Platform for Catheter-Based Procedures

MRI Interventions Inc. and Siemens Healthcare have agreed to co-develop and commercialize a next-generation software platform that will enable minimally invasive catheter-based procedures to be performed under real-time magnetic resonance imaging (MRI) guidance.

Virtually all catheter-based interventions currently are performed 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 instead of fluoroscopic guidance. This shift to MRI-guided procedures is significant because MRI provides superior visualization of soft tissue, MRI provides continuous 3-D visualization, and MRI 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, now in 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 parties, 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. Under this new agreement, MRI Interventions — 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,” said Robert Krieg, vice president MR Product Innovation & Definition at Siemens Healthcare. “We see tremendous potential to improve patient care by further expanding the therapeutic uses of MRI.”

MRI Interventions develops real-time, MRI-guided therapeutic interventions. The company’s first product, the ClearPoint Neuro Intervention 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, 3-D visualization of the target neuro anatomy and surgical instruments with no radiation exposure for the patient or physician.

“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, 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.”

The ClearTrace system is currently limited to investigational use only and is not available for sale. MRI Interventions has not made any filings seeking regulatory approval or clearance of its ClearTrace system.

“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 Aravind Arepally, M.D., section chief, Vascular and
Interventional Radiology at Piedmont Hospital in Atlanta, Ga. “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.”

Atrial fibrillation (AF) is the most common cardiac arrhythmia and is characterized by a rapid and uncontrolled beating of the upper chambers of the heart. AF affects approximately 3 million patients in the United States, and more than 6.7 million in the United States and Europe combined. AF is a leading cause of stroke in patients 65 years and older. Each year there are between 200,000 and 400,000 new AF cases diagnosed in the United States, and the rate of incidence is increasing. Researchers have estimated that AF prevalence in the United States will exceed 10 million patients by 2050. The therapeutic aim of catheter-based cardiac ablation is to restore a patient’s normal cardiac rhythm by delivering ablative energy to the cardiac tissue involved in the initiation or propagation of the arrhythmias.

Founded in 1998, MRI Interventions creates platforms for performing next-generation minimally invasive heart and brain surgery. The company operates facilities in Memphis, Tenn., and Irvine, Calif.