Medical Device Dailys

Definiens (Munich, Germany/Morristown, New Jersey) has launched a multi-dimensional image analysis platform, called Definiens XD, capable of extracting previously unattainable levels of intelligence from digitized medical data.

The company earns half of its revenue from licenses and application in North America, primarily for advanced analysis of cellular activity for life sciences research, but said the launch of the XD platform marks a milestone in entering the medical imaging market.

Definiens software provides automated comparison of data captured over time by different imaging modalities.

To this point the company has commercialized a 2-D analysis platform and with the XD version will apply comparisons for volumetric measurement to 3-Dl structures, calling it "the most challenging but most accurate way of measuring structures of interest, including various lesions in the human body."

Tracking of cells in three dimensions over time, a fourth dimension, provides insight from data into morphology and structure.

The challenge the company has been wrestling with since the 2000 launch of its 2-D image analysis software has been the data volume, which for a single image can easily reach gigabyte levels.

"A 2-D snapshot might give you 250,000 data points," product marketing manager Nick Arini told Medical Device Daily. "A 4-D view of the same cells can provide 500 million data points. We provide the technology that can analyze the enormous amounts of data involved with quantitative and repeatable measurements."

Definiens XD is built on the company's Cognition Network Technology, developed by the Nobel Laureate for Physics, Gerd Binnig, to emulate human cognitive processes — and uses objects' color, shape and size, as well as their specific context and relationships, for comparative analysis.

Definiens differentiates itself from pixel-based and model-based matching technologies with a capability to recognize groups of pixels as objects, and then pick out shapes, colors and textures.

The XD software examines objects contextually, interpreting scale, overlapping objects and the relationship of 2-D images to 3-D shapes.

Noting the trend toward combinations of medical imaging techniques that create a complex mix of data, Wolfgang Rencken, executive vice president, technology and products at Definiens, said he sees opportunity in automating analysis of medical imaging data for screening, treatment planning and staging, and computer-aided detection (CAD) applications.

He said the XD software is "future-proof," as it already is capable of integrating data from emerging medical imaging technologies such as confocal endo-microscopy and fluorescence imaging, as well as kinetic and chemotactic assays.

Definiens is now developing expansion modules for the software with CAD applications for medical professionals.

Definiens established a collaboration with Pfizer (New York) for eCognition, a hyper-spectral platform for image analysis to accommodate future innovations in imaging dyes and hardware (MDD, Jan 18, 2006).

Earlier this year Definiens discussed installations with the French pharmaceutical company Servier (Neuilly-sur-Seine) and the Discovery Research facilities at Suresnes and at Croissy-sur-Seine that specialized in brain disease, cardiovascular conditions, neuropsychopharmacology and oncology.

New EP lab at Royal Brompton Hospital

Stereotaxis (St. Louis) said that British Prime Minister Gordon Brown did the honors at a ceremony unveiling a new electrophysiology lab at Royal Brompton Hospital (London).

The new EP lab features Stereotaxis' Niobe Magnetic Navigation and Odyssey Network systems, which the company said "can provide unsurpassed safety, efficiency and clinical efficacy for the entire range of arrhythmia procedures performed in all four chambers of the heart."

The new lab will be led by Sabine Ernst, MD, consultant electrophysiologist, described by Stereotaxis as "a pioneer in the application of magnetic navigation technology to electrophysiology."

Ernst said, "Magnetic navigation, combined with a very gentle catheter, provides us with more precise catheter placement and allows us to access areas of the heart that may have been hard to reach utilizing other technologies or manual manipulation. As a result, patients with difficult-to-treat arrhythmias may find a successful resolution to their condition through a procedure performed on our new system."

Bevil Hogg, CEO of Stereotaxis, said, "The installation of the combined Stereotaxis Niobe and Odyssey systems at the Royal Brompton Hospital represents another important milestone. We believe [the] Niobe system has demonstrated a peerless record of clinical safety, efficacy, and efficiency over more than 15,000 procedures, and now our Odyssey networked information management system is making it possible for physicians to better manage clinical workflows, archive procedures and is expected to play a critical role in the worldwide dissemination of best practices."

Re-start of clinicals by Impliant

Impliant (Princeton, New Jersey), a developer of spine arthroplasty alternatives to fusion surgery, said it has resumed European clinical activities on its TOPS System, a total posterior arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.

The procedure was performed by the lead clinician of the London Spine Clinic, John Sutcliffe.

Impliant had voluntarily suspended all clinical activities in September 2007 following one device-related failure. After an investigation conducted by a third-party expert in medical device retrievals and the Impliant research and development team, it was determined that device misalignment coupled with excessive shear loading caused the failure.

As a result, Impliant has made what it termed "a few minor design and manufacturing changes" to the internal components of the TOPS device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion.