A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported European CE-mark approval of its first wireless devices to treat patients with heart failure and with potentially lethal heart arrhythmias. The Promote RF CRT-D (cardiac resynchronization therapy defibrillator) and Current RF ICD (implantable cardioverter-defibrillator) feature radio frequency (RF) telemetry for wireless communication with programmers used by physicians to interrogate and program devices.

The company said RF telemetry enables secure, remote communication between the implanted device and the programmers in a clinician's office. "Wireless communication occurs while the device is being implanted and when patients see physicians for follow-up visits, allowing for efficient, more convenient care and device management."

The St. Jude devices use the Medical Implant Communications Service (MICS) frequency band, a range of frequencies designated for medical devices helping to prevent interference from other electronic signals.

The Promote RF CRT-D and Current RF ICD are built on St. Jude's next-generation Unity device platform, a consolidated electronics platform that "will enable [us] to more quickly introduce devices with new features and diagnostics, as they become available, because the basic platform for all of the devices is the same," St. Jude said. It said the platform's expanded capabilities "can support more advanced algorithms and features for better patient management and programming during device follow-up will be streamlined, as all software interfaces for new St. Jude Medical pacemakers, ICDs and CRT devices will be the same."

The Promote RF CRT-D allows physicians to electronically reconfigure left ventricular leads to help optimize the pacing performance without the need to physically reposition the lead. The Ventricular Intrinsic Preference (VIP) algorithm is designed to allow the patient's own heart rhythm to prevail, when possible.

St. Jude said the VIP technology actively monitors the heart on a beat-by-beat basis to provide pacing only when needed, which has been shown to be better for patients' overall heart health.

"Both devices also feature new patient management tools, such as enhanced patient exercise monitoring that gives the physician information about patient activity levels.

The Promote RF CRT-D and Current RF ICD also feature several other company technologies: QuickOpt Timing Cycle Optimization; DeFT Response technology, which is designed to help devices meet the needs of patients with high or varying defibrillation thresholds; SenseAbility technology, designed to optimize sensing to help protect against inappropriate shocks' and vibrating patient notifier, which gently gently vibrates to notify patients of critical changes in device performance instead of issuing the standard audio alert.

The Promote RF CRT-D and Current RF ICD devices are two of more than 20 new cardiac rhythm management products being introduced by the company this year.

St. Jude also reported FDA clearance and the CE mark for the EnSite System Version 7 software, and the CE mark for the EnSite Fusion Registration Module, products that will help physicians create more detailed images of the heart for navigating during electrophysiology procedures that treat complex arrhythmias.

The EnSite System provides 3-D cardiac models to help diagnose and treat many abnormal heart rhythms, including atrial fibrillation. St. Jude said EnSite Fusion is the first and only registration tool with the capability to perform "dynamic registration," which matches two models by creating anchor points on the EnSite images which are then linked to points on the 3-D model of the patient's computed tomography procedure.

"Fusing the geometric- and CT-derived models gives physicians a more detailed image of the heart to help them deliver ablation therapy," the company said.

CEI, German unversity in partnership

Computational Engineering International (CEI; Apex, North Carolina) and the University of Freiburg's (Freiburg, Germany) Department of Diagnostic Radiology, Medical Physics reported a partnership they said would bring new visualization techniques to the medical imaging community. The collaboration will allow researchers to use CEI's EnSight software to conduct advanced blood flow visualization and analysis with conventional DICOM data.

CEI develops software applications for the scientific and engineering community. CEI's products also are used in the biomedical and bioengineering communities. The University Medical Center Freiburg, one of Germany's largest medical centers, is a leading medical research facility.

The partnership between CEI and the university will use EnSight software to bring flow-sensitive 4-D MRI techniques developed at the medical center by Dr. Michael Markl, director of cardiovascular MRI, to more researchers wishing to use visualization techniques to study blood flow.

Markl and colleagues have used the techniques to measure and study blood flows in various types of common vascular diseases such as aneurysms in order to better understand the formation and progression of these conditions.

"We're pleased to help forge new territory in medical imaging with a researcher of Dr. Markl's caliber and with an institution such as the University Medical Center Freiburg," said CEI President Kent Misegades. "But we're even more [pleased] that our partnership will help bring valuable techniques to more researchers, allowing us to enhance and improve our products and advance the use of visualization technology in the medical imaging community."

Markl's techniques take advantage of 3-D spatial encoding and flow-sensitive MRI capabilities to provide anatomical and 3-D velocity information over the entire cardiac cycle for each pixel within a 3-D volume.

"Our partnership with CEI provides the opportunity to integrate EnSight into a clinical environment for direct access to real 3-D flow features inside the human body," said Markl. "We selected EnSight because it is ideally suited to translate novel methodological developments and the resulting data into useful time-resolved 3-D blood flow visualizations."

Markl will also consult directly with other researchers looking to incorporate EnSight visualization technology into their own work.

CEI offers a suite of engineering and scientific visualization tools, from meshing to plotting to animation, on all major operating systems. The company's products can be run on everything from laptops to workstations, clusters and supercomputers, with animations displayed in stereo and in immersive VR.