Diagnostics & Imaging Week and Staff Reports

If it works for brain surgeons, who else might be interested in full-color digital subtraction angiography (DSA) reconstruction?

Siemens Healthcare (Erlangen, Germany) is shifting the sales focus for its syngo iFlow image enhancement software from neurology, where it has enjoyed a solid take-up, to other 'body' interventionalists, such as interventional oncologists and specialists keen on visualizing blood flow for organs and tumors.

Black-and-white photo sequences depicting blood flow have been a staple of medical practice for as long as anyone can remember.

As many as 30 angiographic images that have been digitally subtracted, that is stripped of all background and displaying only blood vessels, are typically taken for a diagnosis of aneurysm coiling and vasospasm, dural arteriovenous fistula, and arteriovenous malformation, for example.

More recently such images have proven essential in both pre- and post-operative assessments for percutaneous interventions to place a stent, a coil tube to support vessel walls.

Even more recently, with advances in contrast agents, blood flow to a tumor can be studied in detail using DSA.

These sequential X-ray images remain in a grainy black-and-white and surgeons flip through them rapidly to study the blood flow as it enters a surgical target and then exits, to assess the extent of any blockage, or the effectiveness of a procedure to remove such blockage.

"The very experienced interventionalists can fuse a DSA sequence in their heads by flashing through the multiple images to understand the blood flow," said Thomas Hartley, marketing manager for interventional radiology at Siemens.

"But for newer doctors and radiology staff, it takes an effort and there is a learning curve" for decrypting DSA images, he said.

The syngo iFlow process combines the 25 to 30 photos in a DSA sequence into a single image where blood flow is color-coded and renders an easy to understand, almost intuitive view of the contrast-loaded blood flowing through the brain, the leg, or organs.

Vessels appearing in red show the early flow while blue depicts late flow in vessels.

Syngo iFlow is a software-based upgrade to the Siemen's Artis zee family of systems used for interventional radiology and cardiology.

"It is not terribly expensive to add this feature," Hartley said. "And it certainly is not expensive if it proves to be clinically useful."

Because the software works with routine DSA sequences, there is no additional exposure to radiation for the patient, which would be the case if blood flow concerns caused the physician to order a 3-D computed tomographic scan.

Hartley said syngo iFlow processes a single frame in less than one second, "so it does not take very long to recompose the series into a single image of the dynamic flow," he said.

The learning curve is not steep, either.

"The radiologists marks a tart and an end point and clicks a button," he said.

"We see a strong potential for clinical procedures outside of neurology, which remains our primary focus," he said, adding that for leg stenosis syngo iFlow should prove clinically significant for pre- and post assessments.

"There is also a whole class of interventionalists working on the liver, kidneys and other blood-intensive organs that we are targeting," Hartley said.

Syngo iFlow has also proven useful in making more vivid a phenomenon known as "tumor blush", the sudden visualization of a tumor as it fills with a contrast agent, indicating that interventional oncologists hay find the software upgrade helpful.

Syngo iFlow holds a CE mark, clearing it for sale in more than 30 countries, and is currently being reviewed in a 510(k) application to the FDA.

An added benefit for an easy-to-understand image of blood flow is for the patient, Hartley said.

"In some markets, such as the U.S. where there is an effort to show the outcome of an intervention to a patient, reconstructing the images into a single, understandable color image can be a convincing before-and-after demonstration," he said.

New neurosurgery systems from Renishaw

Renishaw (Wotton-Under-Edge, UK), a leader in engineering technologies, is introducing an exciting line of high precision systems for functional and stereotactic neurosurgery at the 15th quadrennial meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) taking place in Toronto from May 24-27.

These include the neuromate surgical robot, and image-guided stereotactic technologies, some of which are still in development.

To mark the introduction, the company will also be hosting a special satellite event at the Toronto Cricket Club on May 24, with two leading neurosurgeons to speak about their experiences with surgical robotics and other new stereotactic technologies, and their vision for their future use.

Olivier Delalande, MD, pediatric neurosurgeon at the Fondation Rothschild Hospital (Paris), will discuss his pioneering use of the neuromate stereotactic robot to perform paediatric procedures, including Stereo Electro-Encephalography for epilepsy, and neuroendoscopic disconnection for hypothalamic hamartoma.

Professor Steven Gill of Frenchay Hospital (Bristol, UK), who is well-known for his pioneering work in placing deep brain stimulation leads, will also discuss the clinical applications of new technologies in the targeted delivery of therapeutics and their drive towards the requirement for advanced stereotactic systems.

Renishaw Chairman/CEO Sir David McMurtry said, "Our commitment to the neurosurgical market is built around listening to the needs of our clinical customers and then delivering advanced precision systems to meet their requirements."

Other Renishaw product lines include laser calibration systems for machine performance analysis, 3-D dental scanning and milling systems, linear and rotary position encoders, Raman spectroscopy systems for spectral analysis of materials, and most recently medical devices for neurosurgical applications.

In the year ended June 2008, Renishaw had revenues of £201.2 million and profit before tax of £41.7 million. The Renishaw Group has some 50 locations in 31 countries, employing more than 1,800.

St. Jude reports first European use of EnSite

St. Jude Medical (SJM; St. Paul, Minnesota) reported European CE-mark approval and first use of its EnSite Velocity Cardiac Mapping System, which it said has been designed to help physicians "more efficiently diagnose and deliver therapy to treat abnormal heart rhythms."

SJM is featuring the EnSite Velocity System in its booth at this week's Heart Rhythm Society (Washington) scientific sessions in Boston.

The company said advancements in the EnSite Velocity System's design are focused on increasing procedural efficiency, from set-up and operation, to clinical application and use.

With new hardware and software, the system offers simple set-up and connections, an intuitive software interface and includes two key new capabilities: the OneMap tool and RealReview function.

The OneMap tool enables physicians to simultaneously create a detailed cardiac model and electrical map using multiple catheters and electrodes, allowing physicians to collect and display more relevant patient information in a shorter amount of time.

The RealReview function provides real-time, side-by-side views of the live procedure and previously recorded portions of the procedure, giving physicians a quick and easy comparison of events and results at different times throughout the procedure, without losing the ability to visualize and navigate catheters in real-time.

"The EnSite Velocity System allows me to efficiently collect anatomical and mapping data with whichever catheter I believe is most appropriate for the procedure. The system's versatility and catheter choice is important, providing me with enhanced control during the procedure," said Tony Chow, MD, of The Heart Hospital (London).

St. Jude said the system "maintains the strengths and clinical utility that have made the EnSite System the leading cardiac mapping system, while incorporating significant improvements into the design. Additionally, the EnSite Velocity System is an open platform, which means that it is compatible with essentially all diagnostic and ablation catheters, recording systems and energy sources used for ablation procedures.

"The EnSite Velocity System functions as though it were designed with the entire lab in mind; the simple setup and intuitive operation are incredibly helpful in supporting efficient procedural workflow," said Christopher Piorkowski, MD, of Herzzentrum Leipzig (Leipzig, Germany). "Because my practice has a fast-growing population of patients to serve, such efficiency gains benefit not only my patients but also other members of my team."

Jane Song, president of the St. Jude Medical Atrial Fibrillation Division, said, "As the next generation in cardiac navigation and visualization technology, the EnSite Velocity System is designed to integrate seamlessly with existing lab technology, while having built-in flexibility to allow for integration with future technologies."

St. Jude also reported CE-mark approval of its Promote Accel implantable cardiac resynchronization therapy defibrillator (CRT-D). The Promote Accel CRT-D automatically tailors treatment to individual patient needs by measuring the heart's reaction to therapy and ensuring that the heart is responding, providing the dual benefit of added safety for the patient and added efficiency for physicians.

The Promote Accel CRT-D family of products also features the QuickFlex m (micro) left ventricular lead and CPS Aim SL slittable inner catheter subselector designed to offer safer, more efficient implantation procedures and therapy delivery for patients with heart failure.

Oxford Biosensors is for sale

UK biotech firm Oxford Biosensors (Oxford, UK) has been put up for sale following the withdrawal of its existing backers.

The company has developed technology for point-of-care electrochemical testing for lipids and other analytes, for use in the cholesterol, diabetes and renal function diagnostic testing markets.

Oxford's lead product is a lipid diagnostic panel designed for monitoring patients' cardiac risk and the impact of therapy, leading to an improvement in clinical outcomes. The panel enables the testing to be undertaken in the doctor's office in about five minutes with results comparable to those performed in a clinical laboratory. This product is now being finalized for FDA approval and launch.

In addition to the lipid panel, the company has begun work on other panel products for metabolic conditions, diabetes and renal function. Initial feasibility on these pipeline products has already been completed.

Since 2000, Oxford Biosensors has raised about £18 million, including equity, grants and corporate partnership revenues.

The company operates from a research and development facility at Yarnton, Oxford.