A Medical Device Daily

Results of the first study to use magnetic resonance imaging to examine the effect of a statin, rosuvastatin – Crestor from AstraZeneca (London) – on the fatty plaques in arteries, were presented last weekend at the 75th European Atherosclerosis Society congress in Prague, Czech Republic.

The ORION study, which is part of the GALAXY global research initiative sponsored by AstraZeneca, maker of Crestor, to investigate cardiovascular risk reduction and patient outcomes with rosuvastatin, revealed that rosuvastatin has a beneficial effect on the size and composition of fatty plaques in arteries, specifically the carotid artery in the neck.

Atherosclerosis, the build-up of fatty deposits or plaques in the arteries, is the main cause of cardiovascular disease (CVD), causing up to 70% of all CVD deaths.

Results from the ORION study indicate substantial reduc- tions in bad cholesterol (LDL cholesterol) with rosuvastatin treatment were associated with arrested progression of atherosclerosis and regression of the large fatty core (lipid-rich core) in the most diseased sites of plaques.

Plaques with a lipid-rich core are recognized to be vulnerable to rupture, which can result in sudden cardiovascular events such as heart attacks and strokes, often without any prior symptom.

T.S. Hatsukami, MD, of the University of Washington School of Medicine (Seattle), lead investigator of the ORION study, said, “Results from ORION, a study that uses advanced MRI techniques to characterize plaque size and composition, suggest that intensive LDL-C lowering treatment with rosuvastatin may reduce the lipid-rich areas at the most diseased sites within carotid plaques, and is associated with arrested progression in overall plaque burden.”

The study involved 35 patients with moderate hypercholesterolemia and asymptomatic carotid artery atherosclerosis, who were treated with either rosuvastatin 5 mg or 40 mg for two years. The results reported this past weekend showed that rosuvastatin 5 mg and 40 mg “significantly reduced LDL-C by 39% and 58%, respectively, from baseline.” It also was associated with arrested progression of carotid atherosclerosis from baseline.

Sarah Jarvis, MD, a general practitioner from London, said, “The ORION study shows us that we can make a real difference to this process, which could translate into significant benefits in terms of patient health and survival.”

NICE backs use of HIFU for prostate cancer

Misonix (Farmingdale, New York), a developer of ultrasonic medical device technology for the treatment of cancer and other healthcare purposes, said the UK’s National Institute for Clinical Excellence (NICE) has issued a guid- ance report to the National Health Service (NHS) in England, Scotland and Wales on the use of high-intensity focused ultrasound (HIFU) for prostate cancer treatment.

The guidance report suggests that reimbursement for HIFU should be determined shortly. Upon such determination, Misonix said it believes that HIFU treatment using Focus Surgery’s (Indianapolis) Sonablate 500 device, which is distributed by Misonix, would become a more acceptable and affordable treatment for prostate cancer, which may be offered throughout the UK through the NHS.

The Sonablate 500 uses HIFU for the treatment of prostate cancer. Misonix distributes the Sonablate 500 in Europe and has sold a unit in London, among other markets. Misonix is a minority owner of Focus Surgery.

According to the guidance report, “NICE has considered [HIFU for prostate cancer] because it is relatively new. NICE has decided that the procedure is safe enough and works well enough for use in the NHS.”

The NICE report described HIFU as being “markedly different” from other therapies in that it “does not involve an incision and therefore avoids the risk of a surgical site infection, avoids ionizing radiation and its associated acute and chronic toxicities, and can be administered as a day case procedure using local anesthesia, resulting in a patient discharge one to two hours after the procedure.”

NICE, which is part of the NHS, is responsible for providing national guidance on treatments and care for people using the NHS. Such guidance is developed using the expertise of the NHS and the wider healthcare community, including NHS staff, healthcare professionals, patients and caregivers, industry and the academic community.

Nick Stevens, managing director of UKHIFU, the Misonix distributor for the Sonablate 500 in England, said, “The interest we are receiving in the Sonablate 500 has increased significantly. Consumers and potential patients are recognizing the advantages of the Sonablate 500 for many appropriate procedures over alternative and more radical treatments such as surgery or radiation.”

The UK Department of Health has released figures showing the number of patients diagnosed with prostate cancer has increased by 50% in the last five years and will reach an expected 40,000 a year by the end of 2005.

New CFO for In Veritas

Martin Thorp has been named CFO for In Veritas Medical Diagnostics (IVMD; Inverness, Scotland). He has been an independent consultant since 2002, including serving as a strategic advisory non-executive board member of Grant Thornton.

In Veritas, which recently changed its name from the previous In Vivo Medical Diagnostics, consists of two subsidiaries based in the UK, IVMD Ltd. and Jopejo Ltd. IVMD reports being “in the final stage” of developing a medical device for the cardiovascular market.

Other medical conditions being addressed by IVMD’s technology include the diabetes market and other areas relying on imaging. Jopejo reports being in the late stages of developing new monitoring devices that utilize signal processing for late-term pregnancy.