A Diagnostics & Imaging Week

Health Secretary Alan Johnson reported last month that the UK government had launched a consultation into the future of stroke services, saying the challenge is to modernize stroke services at every stage and drive down death and disability caused by strokes.

Stroke is the third-biggest killer in England, and the Department of Health said that, despite more money being spent on stroke care in recent years, care for stroke patients is still lagging behind the other two major killers — heart disease and cancer.

The consultation on stroke services published by Heart and Stroke Director Professor Roger Boyle will look at how the National Health Service (NHS) can bring the standard of stroke care into line with that of heart disease and cancer. The consultation will shape the final “Stroke Strategy,” which will be rolled out later this year.

“Despite the considerable gains in developing stroke units over the last few years, there remains more to be done to bring stroke services in line with cancer and heart disease services,” Johnson said. “That is why I asked Professor Boyle to work with the experts and stroke patients to look at how best we can improve prevention, treatment and care.”

Johnson said that stroke mortality is falling, with the death rate for those under 65 down by 23% since 1993, but that more needs to be done.

“We began by focusing on coronary heart disease, the biggest killer in the country. Now we must redouble our efforts in addressing the challenge of stroke.”

Boyle said, “I want to see better public awareness of how they can prevent strokes and what the early signs are so they get the treatment they need in time. Getting proper, early treatment can mean the difference between long-term paralysis or walking out of hospital a few days after your stroke. It is vitally important that we get this right.”

He added: “NHS services may also need to be reorganized within NHS Trusts or local areas to ensure that patients receive faster care. By redesigning services so that people can be given the newest treatments in specialist centers, including clot-busting drugs, 1,000 people who have a stroke a year could regain independence rather than die or be left dependent on others.”

Biofield licenses MacKay for China j-v

Biofield (King of Prussia, Pennsylvania), which late last month granted a master license to the MacKay Group (Hong Kong), reported that MakKay has signed a memorandum of understanding to form Biofield Asia in a joint venture with United Premier Medical Group (UPMG; Hong Kong).

UPMG delivers healthcare services to China in partnership with well-known Western healthcare providers, including through its VIP ob/gyn centers in that country.

Biofield develops non-invasive diagnostic medical devices to assist in detecting breast cancer. Its Biofield Diagnostic System (BDS), a breast cancer diagnostic device, employs single-use sensors to measure and analyze changes in cellular electrical charge distributions associated with the development of epithelial cancers. The BDS device is intended for palpable breast lesions in women under 55 years of age.

Biofield Asia will exclusively market, distribute, manufacture, and further develop and conduct R&D on the BDS in or for mainland China, Hong Kong, Macau, Taiwan, Singapore, Malaysia, the Philippines, Japan, Korea, Indonesia, India and Australia.

UPMG will seek approval from the State Food and Drug Administration in China, will purchase BDS devices and sensors, and will pay undisclosed sums to Biofield pon certain milestones related to regulatory approval, manufacture, and sales in China and certain countries.

Biofield said UPMG “has bridged the cultural, technological and medical gaps between the U.S. and China and has shown that it is capable of delivering high standards of healthcare services to China on a local and national level to meet the ever-increasing demand.”

Biofield CEO Michael Antonoplos said: “This is the dawn of a new era for Biofield and we hope the beginning of a new era for women worldwide. Given its strategic partnership with leading western healthcare providers in China, we believe that there is no better institution than UPMG to bring together the best from East and West to fight cancer.”

Antonoplos said he believes the new partnership with UPMG “will usher in the type of joint clinical trials, R&D, advancement of Biofield’s technology and other East-West government-industry collaboration, [that] will benefit women and areas outside Asia, including the U.S., and which could help the fight against other cancers.”

Two more sites join in CardioFit trial

BioControl Medical (Yehud, Israel) reported that cardiologists and surgeons at University Hospital Mannheim in Germany and Ospedali Riuniti di Bergamo in Italy have successfully implanted the company’s CardioFit device in the first patients to be enrolled at those sites in BioControl’s international, multi-center clinical study of the CardioFit system for the treatment of advanced congestive heart failure.

The CardioFit system works by applying electrical impulses to the vagus nerve. A sensing electrode in the right ventricle detects the patient’s heart rate and is used to control nerve stimulation.

“Our early results support our belief that CardioFit may contribute significantly to how heart failure patients are treated in the future,” said M. Borggrefe, MD, principal investigator for the BioControl trial at Mannheim.

A. Gavazzi, principal investigator for the BioControl study at Bergamo, said, “Clearly, there is an unmet clinical need for effective treatments for this condition. We believe the CardioFit system has a high potential to fill this need.”

The study is now in progress at IRB-approved sites in Europe, Israel and Australia. Bergamo and Mannheim join four other sites in Europe actively enrolling patients for the CardioFit system study, all of which have already successfully implanted the device in trial patients.

BioControl develops and markets advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes.

In April 2006, American Medical Systems (Minnetonka, Minnesota) exclusively licensed BioControl’s technology for its miniaturo system, to develop it as a treatment device for urge incontinence and interstitial cystitis. Funds secured from that transaction are being used by BioControl to support the development of the CardioFit system for the treatment of CHF.