A Medical Device Daily

Delivery of trauma care in Britain is threatened by a lack of training opportunities and a dedicated service infrastructure within the National Health Service, say doctors in the most recent issue of the

British Medical Journal.

Efforts to improve training have been hampered by the absence of a dedicated trauma service infrastructure within the NHS, while demands from surgical institutions for a national framework for trauma management and centralization of expertise have not been heeded, wrote Professor James Ryan and colleagues.

They believe that the UK's surgical institutions should re-examine the issue of trauma training for surgeons. “In particular, Britain needs a robust way of identifying, training, and accrediting a cadre of surgeons with the potential to become clinical champions of trauma services,“ according to the report authors.

“Sanctioning the birth of acute care surgery as a discrete discipline could provide a training path and career structure for trauma surgeons,“ they write. “More importantly, such a development may encourage a retooling of provision in a health service that has so far escaped all efforts to systemize the care of the seriously injured.“

Misonix buys UK distributor

Misonix (Farmingdale, New York), a developer of ultrasonic medical device technology to treat cancer and other conditions, said that it has acquired a controlling interest in its UK distributor, UK-HIFU , to expand its high intensity focused ultrasound operations in Europe. Details of the transaction were not disclosed.

“Our strategy in Europe is intended to broaden the acceptance and use of HIFU-based medical devices made by Misonix,“ said Michael McManus, Jr., president and CEO of Misonix. “With UK-HIFU we will be able to participate more actively in the marketing of our products and have a greater share in the revenues generated by these activities.“

UK-HIFU has been marketing the Sonablate 500 in the UK for Misonix for nearly two years. Nick Stevens, managing director of UK-HIFU, said, “We have had significant success in the first two years of working together.“

The Sonablate 500, manufactured by Misonix, has the CE mark and has been approved by the UK's National Institute for Clinical Excellence (NICE). NICE issued a guidance report to the NHS in England, Scotland and Wales on HIFU for prostate cancer treatment in mid-2005. UK-HIFU said it has been working with regulators to secure insurance reimbursement for prostate cancer treatments using the Sonablate 500.

The UK Department of Health has released figures showing the number of those diagnosed with prostate cancer has increased by 50% in the last five years.

Initially marketed for outright purchase by users, the device is now also available on a fee-per-treatment basis. In the UK, there are currently 23 Sonablate 500 HIFU treatment centers, eight surgeons fully trained to use the device, 11 surgeons operating with the assistance of a supervising surgeon, and eight more surgeons in the early stages of training, Misonix said.

Misonix's ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications.

Elekta wins MRC CBU contract

Elekta (Stockholm, Sweden) has won a contract to deliver Elekta Neuromag, equipment for non-invasive registration of nerve cell activity using magnetoencephalography (MEG) technology to the renowned center for research in cognitive neuroscience, the MRC Cognition and Brain Sciences Unit (MRC CBU; Cambridge, UK).

CBU is a major concentration of cognitive scientists and neuroscientists, with nearly 100 active scientists, students and research staff. A priority in the CBU research strategy has been to develop a research program in neuro imaging, with more than half of the scientific staff and students involved in neuro imaging projects. From emotions and memories to language and learning, functional neuroimaging is being applied in many different areas of cognitive neuroscience.

Using MEG technology to measure the intensity of weak magnetic fields generated by electrical activity in the brain, MRC CBU will non-invasively register nerve cell activity in the brain in real time, increasing the ability to improve treatment of functional disorders.

MEG offers functional mapping information and measurement of brain activity in real time, unlike CT and MRI and fMRI which only provide structural, anatomical and metabolic information, according to Elekta.

“The scope of the research collaboration agreement offered by Elekta Neuromag, and the associated benefits, were an important component of the added value brought to the MRC CBU by the Elekta tender,“ said Professor William Marslen-Wilson, director of the MRC CBU.

Elekta reports its systems used at more than 3,000 hospitals to treat cancer and manage clinical operations as well as to diagnose and treat brain disorders.

Transplant monitoring study at ISHLT

A recent study shows promise for cardiac transplant patient monitoring with new non-invasive procedures to help predict organ rejection.

Mandeep Mehra, MD, head of the Division of Cardiology at the University of Maryland School of Medicine (Baltimore), presented the study last week in Madrid at the 26th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT).

The study was sponsored by XDx (South San Francisco), whose laboratory provides the gene expression testing service, the AlloMap test, used in this investigation.

Data from the study show that a gene expression pattern in heart transplant patients, initially validated to detect the absence of ongoing acute cellular rejection, can anticipate acute cellular rejection.

The study examined the messenger RNA gene expression patterns of 104 heart transplant recipients at least one-month post transplant who showed no signs of current rejection on biopsy. Of the sample, 39 patients developed acute cellular rejection within 12 weeks, and on average, higher gene test scores were noted for those future rejectors, compared to those who remained rejection-free.

The genes actively predictive of rejection were those modified by corticosteroids, a backbone of immunosuppressive drug therapy in transplantation. Similarly, following treatment of rejection, the gene expression patterns showed improvement toward the baseline. These findings were examined further in a series of 192 representative patients, demonstrating a negative predictive value of 98.9% for a gene expression score that indicated quiescence.

ISHLT maintains two databases. The International Heart and Lung Transplant Registry has been collecting data since 1983 from 223 hospitals from 18 countries. The ISHLT Mechanical Circulatory Device database has been collecting data since 2002 with the aim of identifying patient populations who may benefit from implantation or a mechanical circulatory device.