ICUS Weekly News Monitor 11-14-2008

1. BusinessWire, Nov 13, 2008 BK Medical Introduces 8824 Intraoperative Transducer; World’s First Compact Surgical Transducer with Selectable Perpendicular Arrays (Press Release) BusinessWire Nov 13, 2008 BK Medical Introduces 8824 Intraoperative Transducer World’s First Compact Surgical Transducer with Selectable Perpendicular Arrays (Press Release) COPENHAGEN, Denmark -- B-K Medical, a wholly owned subsidiary of Analogic Corporation (NASDAQ:ALOG), announced the release of the world’s first compact surgical transducer with selectable, perpendicular arrays enabling surgeons to more easily access difficult-to-reach sections of the abdominal cavity. The 8824 I and T shaped intraoperative transducer measures only about the length of a matchstick. The small, thin proportions allow access to difficult-to-access and tight areas, while still providing clear, detailed ultrasound images of the liver, pancreas, or kidney. The 8824 allows the surgeon to follow the path of a needle on the ultrasound image when taking free-hand biopsies from the front, back, left, or right of the transducer. The 8824 combines the two most valuable surgical scanning tools: the T shaped and the I shaped arrays. Similar to BK Medical’s V shaped 8814 biplane transducer, the 8824 displays two intersecting planes live and concurrently for improved orientation and needle placement. Depending on the surgeon’s preferred technique and the patient’s specific need, the 8824 offers the flexibility of using the two arrays individually or simultaneously, each providing a clear, quality image. The 8824 is capable of providing the advantages of CEUS1 (contrast-enhanced ultrasound imaging). CEUS is proving to be a very valuable addition to the surgical portfolio, aiding in the detection of lesions and the evaluation of vascularity. Compared with traditional B-mode ultrasound imaging, CEUS can provide the surgeon with additional information that is crucial to accurate diagnosis and the verification of treatment. As the market leader in surgical ultrasound, BK continually builds upon its already extensive and innovative portfolio. Michael Brock, President of BK Medical, said “We developed the 8824 after extensive research into the clinical needs of surgeons. Our products deliver the technical advantages that surgeons are searching for and are flexible enough to match preferred surgical methods. The 8824 allows our customers to address their patients’ needs using the best possible surgical aid.” 1 In the USA, contrast-enhanced ultrasound has not been market cleared by the FDA, with the exception of only select cardiac imaging applications.

ICUS Weekly News Monitor 11-6-2008

1. MarketWatch, November 4, 2008, National Association Endorses Recommendations for Contrast Agent Use in Heart Ultrasounds (Echocardiograms) Press Release 2 MarketWatch, November 5, 2008, Lantheus Medical Imaging Welcomes New ASE Consensus Statement on Clinical Applications of Contrast Echocardiography 3, November 5, 2008, Serious Complications and Death Linked to Heart Imaging Drugs. By: David Gutierrez

ICUS Weekly News Monitor 10-31-2008

1. MarketWatch, Oct 27, 2008 Cardiovascular Diagnostic Center Limits Radiation and Contrast Dosage Using Toshiba's Industry Leading Technology 2. News-Medical.Net (Sydney, Australia), Oct 26, 2008 Sensitive ultrasound to spot early-stage cancer 
 MarketWatch Oct 27, 2008 Cardiovascular Diagnostic Center Limits Radiation and Contrast Dosage Using Toshiba's Industry Leading Technology The diagnosis and subsequent treatment of cardiovascular disease can be accomplished through a variety of medical imaging modalities. Demonstrating the effectiveness of a multi-modality approach, Salinas Valley Memorial Healthcare System created the Cardiovascular Diagnostic Center at its Ryan Ranch outpatient facility in Monterey County, Calif. to provide cardiac disease treatment to its patients with a full suite of imaging equipment from Toshiba America Medical Systems, Inc. Salinas Valley Memorial Healthcare System will use the Toshiba Aquilion(R) ONE computed tomography (CT) system and the Vantage(TM) Atlas magnetic resonance (MR) system to deliver the highest quality of patient care. In addition, Toshiba's Aplio(TM) Artida ultrasound system is being used by Salinas Valley's director at his professional practice to further evaluate cardiac patients. The Cardiovascular Diagnostic Center is led by Dr. Timothy Albert, assistant consulting professor of medicine at Duke University. The Cardiovascular Diagnostic Center is the only facility in California to use these Toshiba technologies side-by-side to provide imaging with low doses of contrast and radiation. "Using a combination of the latest CT, MR and ultrasound technologies allows us to offer the most effective and safest patient care to the community," said Dr. Albert, director, Cardiovascular Diagnostic Center, Salinas Valley Memorial Healthcare System. "When a patient is displaying a specific set of symptoms, we are capable of imaging them right away on the most appropriate system. That way, we can reduce both the contrast and radiation dose a patient receives." The Cardiovascular Diagnostic Center acquired the Toshiba Aquilion ONE dynamic volume CT system to perform advanced cardiovascular CT imaging. The Aquilion ONE utilizes 320 ultra-high resolution detector rows (0.5 mm in width) to image the heart in a single gantry rotation. The result is unparalleled in diagnostic imaging today and produces a 4D clinical video showing up to 16 cm of anatomical coverage, enough to capture the entire heart, and show its movement such as blood flow. "CT is the gold standard for coronary imaging because of the high image resolution and fast acquisition time," stated Dr. Albert. "The rapid, efficient cardiac imaging and the lower radiation dose of the Aquilion ONE CT system was a perfect fit for the new cardiovascular center. The Aquilion ONE is able to lower radiation dosage by up to 80 percent, making CT imaging safer for patients." The Center will use Toshiba's Vantage Atlas MR system in the diagnosis of cardiovascular disease and Toshiba's proprietary contrast-free MR methods to improve patient safety. Unlike some other diagnostic tests, MR shows both anatomy and function, such as blood flow, and is used in analyzing valve structure and heart function. Additionally, MR offers an imaging alternative without any radiation. "MR has revolutionized the way we look at the heart," explained Dr. Albert. "New MR technology creates movie-quality images of the heart, which is like the difference between old black and white television versus today's high-definition television." The Center will also take advantage of Toshiba's industry leading, proprietary contrast-free MR techniques, which include Fresh Blood Imaging (FBI), Contrast-free Improved Angiography (CIA), Time-Spatial Labeling Inversion Pulse (Time-SLIP) and Time and Space Angiography (TSA). The contrast-free protocols are particularly important in imaging vascular disease and patients with kidney dysfunction. At Dr. Albert's professional practice, he uses the Toshiba Aplio Artida ultrasound in the evaluation of heart muscle and valve function. The 4D imaging and 3D wall motion tracking create detailed images allowing for the highest levels of diagnostic confidence. "The work being done by Dr. Albert and Salinas Valley Memorial Healthcare System will change the way physicians use the full suite of Toshiba systems, including CT, MR and ultrasound to diagnose cardiovascular disease," said Girish Hagan, vice president, Marketing, Toshiba. "Across the board, Toshiba's advanced technology is making medical imaging safer for patients by dramatically reducing radiation and eliminating contrast agents in certain procedures." About Salinas Valley Memorial Healthcare System Salinas Valley Memorial Hospital is a Public District Hospital that is part of the Salinas Valley Memorial Healthcare System. The Healthcare System is an integrated network of health care programs, services and facilities. At the core of the system is a 269-bed acute care hospital with several distinct specializations and programs, including the Regional Heart Program, the Comprehensive Cancer Center, a Level III Neonatal Intensive Care Unit (NICU), Joint Replacement Center, and the Regional Spine Center. Salinas Valley Memorial employs more than 2,200 people and the Medical Staff includes 265 board-certified physicians across a range of specialties. News-Medical.Net (Sydney, Australia) Oct 26, 2008 Sensitive ultrasound to spot early-stage cancer European researchers have developed highly sensitive ultrasound equipment that can detect tiny quantities of reflective microbubbles engineered to stick to specific tumour cells. The technique should pick up tumours early and improve patients' chances of survival. Most of the current diagnostic methods - biopsy analysis, biochemical tests and medical imaging - are not sufficiently sensitive. They frequently return a false negative; the tumour is only discovered when it is much bigger, and too late. European researchers are developing a new technique that will help medical professionals visualise tiny quantities of pathological tissue in patients. The technology could localise tumours in their very earliest stages of development and help doctors begin treatments much earlier, giving patients a much better chance of survival. The new approach uses medical ultrasound, a safe technology most commonly used for pre-natal visualisation of the foetus and the imaging of other soft tissues. A probe sends high-frequency acoustic waves into the body and detects how they bounce off the interfaces between different tissues. To improve the sensitivity of this imaging technique, a sonographer may sometimes inject a so-called contrast agent into patients, which greatly increases the scattering of the acoustic waves back to the probe. For ultrasound imaging, contrast agents are based on 'microbubbles', micron-sized gas-filled balls that show up brightly on the ultrasound image. Researchers in the EU-funded TAMIRUT project have developed a microbubble medium that can specifically target and bind to certain pathogenic cells in the body (such as endothelial cells of vessels lining the tumours). Combined with enhanced ultrasound equipment and signal processing capabilities, the system can detect where microbubbles adhere to target cells, and reveal the presence of early-stage tumours. Working with the pharmaceutical company Bracco Research S.A. in Switzerland, TAMIRUT researchers have developed a way to attach antibodies onto the surface of microbubbles. By selecting an antibody with an affinity for marker molecules found only on target vascular cells, the microbubbles 'stick' only to the target cells. But it is not easy to pick up these hotspots on a scan. "We are looking at the very earliest stages of tumour growth, so there are not many cells present expressing the marker of interest," explains Alessandro Nencioni who coordinated the project. "There may be only three or four microbubbles adhered to a site and current ultrasound equipment is not able to pick these up. Work on the hardware and signal processing is an essential aspect of this project as we seek to develop next-generation ultrasound imaging capabilities." Strong signals Esaote, an Italian manufacturer of medical imaging equipment, is working with several research partners and two SMEs: Vermon, a French manufacturer of medical imaging probes, and SignalGeneriX, a small firm based in Cyprus with expertise in signal processing. Their aim is to produce a scanner and a dedicated probe that can transmit and receive ultrasound waves across a wide range of frequencies and wave forms in order to exploit (without any modification) the harmonic components caused by nonlinear scattering of the acoustic wave of the microbubbles. The scanning equipment must have sufficient processing power to interpret the waves picked up by the probe, update the live image and adjust the transmitted waveforms in real time. Their detecting function is ensured by a specifically developed signal processing methods, able to detect a very limited number of microbubbles (down to a single bubble), to estimate their concentration, and to track their behaviour to get the diagnostic answer searched. Originally, the project partners thought it would be possible to differentiate between bound and unbound microbubbles by the way they scatter particular ultrasound frequencies and wave forms. However, extensive simulations and laboratory testing have shown that this turns out to be very difficult. Instead, the scientists found a very simple answer: after 10 minutes, the microbubbles that are attached to target cells remain in place while the free microbubbles diffuse away. The new probe will detect and calculate their local concentration and operators will be able to visualise any areas of high microbubble density within an entire organ. The repetition of this new imaging technique over time could help medical staff to assess the evolution of a tumour, especially its vascularisation. Using the engineered, targeted microbubble contrast agent, the improved ultrasound hardware and the signal processing, the TAMIRUT team has already demonstrated in simulations the potential of this approach for the early detection of prostate cancer. "Our approach goes a long way to eliminating or strongly reducing the problem of false-negative diagnosis," says Nencioni, "offering a second degree of evaluation after blood test screening. It is sensitive, specific and you are able to examine the whole organ, which is not possible by biopsy." This ultrasound method improves accuracy, patient comfort and costs around half that of a biopsy. It could save European healthcare providers up to ?250 million each year in biopsy costs alone. The need for clinical trials of the targeted contrast agent and subsequent approval in humans means that the targeted microbubble agent is unlikely to be available for at least three years. But the improved signal processing algorithms will help to increase the sensitivity of ultrasound equipment, irrespective of the use of these microbubbles. Esaote is working with the other commercial partners to incorporate the new signal processing features into its medical imaging equipment by the end of 2009.

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