A Medical Device Daily

The transfer of responsibility for health services in UK prisons to local primary care trusts (PCTs) continues, with 86 prisons transferring such responsibility to 63 local PCTs at the beginning of this month.

As a result of this second wave of transfers, the program of switching responsibility for prison healthcare to PCTs now has seen the vast majority of prisons completing such transfers a year ahead of schedule.

The first wave of transfers, completed a year ago this month, saw 18 local National Health Service (NHS) partnerships assume responsibility for healthcare in 34 prisons.

The British Home Office deadline for having all prisoner healthcare commissioned by local PCTs is April 1, 2006. The four remaining prisons will be working toward transferring responsibility by that date.

The transfer of responsibility applies to health services in the public-sector prisons in England. General health services in the 11 privately contracted prisons in England and Wales are part of the overall contract with the Home Office.

In Wales, strong partnerships have developed between the prisons and the local health boards and commissioning for the public sector prisons in Wales is expected to transfer to the local health boards in April 2006.

Paul Goggins, minister for prisons and probation, said: "We are committed to providing prisoners with access to the same quality and range of health services as the general public, and this is best delivered by transferring responsibility for healthcare in prisons to the NHS. I am delighted that so many PCTs/prison partnerships are ready to transfer a year ahead of schedule. This demonstrates the strength of the local partnerships and the desire by those in both the Prison Service and the NHS to provide a better standard of healthcare to people who find themselves in prison."

European trial begins

Cardiovascular Systems (Minneapolis) said the first 12 patients have been enrolled in the European clinical trial of its Orbital Atherectomy System for the treatment of peripheral artery disease.

The first-ever use of the device in patients was performed by Horst Sievert, MD, director of the CardioVascular Center at Sankt Katharinen Hospital (Frankfurt, Germany) on March 29. Thomas Zeller, MD, of Herz-Zentrum (Bad Krozingen, Germany), began treating patients last week. The trial is expected to enroll up to 65 patients at up to four centers.

The Orbital Atherectomy System uses a diamond-coated, eccentrically rotating cutting surface to ablate tissue. Cardiovascular Systems said the resulting particles are small enough to pass through capillaries and be eliminated by the body.

The company is working on obtaining FDA clearance for use of the device in peripheral vascular disease and for use in coronary arteries. It has previously received FDA clearance to remove tissue causing stenosis in synthetic arterio-venous shunts. It said it expects to conduct initial market testing at a limited number of clinical sites before undertaking full commercial release of the product for that indication.

DOBI adds another distributor

DOBI Medical International (Mahwah, New Jersey) said it has signed a new distributor agreement for the ComfortScan system with Prisma Imaging Western Europe (Naples, Italy). The ComfortScan system is a light-based, non-invasive optical imaging tool designed to assist physicians in the diagnosis and management of breast cancer.

Under the agreement terms, Prisma will conduct a clinical trial in Rome using the ComfortScan system to show the quality of the system and obtain local acceptance and registration specific to the countries of Italy, Portugal and Bulgaria.

With the addition of Prisma, the DOBI Medical global distribution network now includes 10 international distributors covering four continents. Countries where the system is available include Brazil, Canada, Colombia, Costa Rica, Nicaragua, the Czech Republic, Greece, India, the Netherlands, Panama, Russia and Switzerland.

DOBI said it plans more distribution announcements this year.

According to the European Network of Cancer Registries, breast cancer is the most common cancer among females in both Italy and Europe.

Vincenzo La Bella, president of Prisma Imaging, said, "The ComfortScan system represents one of the most promising and useful tools for women's health. This system is designed to not only see, but also understand the functional mechanism of the disease without [X-ray or ionizing] radiation and invasivity."