A Medical Device Daily

Citing completion of a lengthy review of the company’s worldwide operations, Wright Medical Group (Arlington, Tennessee), said it is planning to close its manufacturing and distribution facility located in Toulon, France.

Wright, a global orthopedic firm specializing in reconstructive joint devices and biologics, said it has entered into discussions regarding the facility’s closure with the local staff representatives of the approximately 130 Toulon-based employees affected.

Saying it expects that the facility closure will be completed by year-end, Wright will transfer all Toulon production to its existing manufacturing facility in Arlington, while the majority of the distribution and administrative activities currently being performed there will be transferred to the company’s European headquarters in Amsterdam, the Netherlands.

CEO and President Gary Henley said during a conference call that the Toulon facility, which came to the company as part of a 1999 acquisition, primarily produces hip products for the European market. He said the plant closure would have no impact on the company’s European business, which he characterized as “quite healthy.”

“After careful analysis and consideration, we have reached a clear conclusion with respect to our worldwide capacities. The closing of our Toulon operations, while painful to all of us, is necessary to ensure the long-term competitiveness of the company,” Henley said in a company statement.

Henley said during the conference call that the pre-tax charges related to the closing of the Toulon facilities will be in the range of $20 million to $25 million, including both cash and non-cash items such as asset impairment charges, severance and benefits costs, external legal and professional fees, and other costs. A portion of those charges are expected to be recorded in each of the second, third and fourth quarters of 2007.

Responding to a question by market analyst Taylor Harris of JP Morgan (New York), Henley said that production at the French facility is ongoing, but will be halted in “the next few weeks.” He said the company has about a year’s supply of the products that have been produced there on hand and that it has more than enough available production capacity at the Tennessee facility to replace that lost by the Toulon shutdown.

Henley noted that an expansion program already was under way at the Arlington facility. He added that there would be “no impact” on European sales and distribution, which now will be handled out of Amsterdam.

GE providing FFDM units in Ireland

GE Healthcare (Chalfont St. Giles, UK) reported supplying full-field digital mammography (FFDM) units to BreastCheck, part of the Irish National Cancer Screening Service (Dublin).

Ireland will become one of the first countries in Europe to entirely use digital mammography for breast screening services provided by BreastCheck. Out of a total of 29 digital mammography systems installed across the country, 13 GE Healthcare Senograph Essential FFDM units will be installed, with six of the 13 systems being mobile units.

BreastCheck currently provides screening to women in the northeast, east, midlands and parts of the southeast of Ireland through two static units and a fleet of mobile units. In 2005, 78,945 women were invited for screening by BreastCheck and 59,443 attended appointments. BreastCheck is expanding the service nationally to offer screening to all eligible women throughout the southern and western regions of Ireland.

According to the National Cancer Registry Office Ireland , the most common cancer in women is breast cancer, which accounts for 28% of all cancers in Ireland. Breast cancer is particularly virulent, it said, and 18.5% of all cancer-related deaths in women in Ireland are due to breast cancer.

GE Healthcare said its technology will mean a shift in the reach of medical care in Ireland, allowing doctors to increase patient workflow, take medical care to patients in even the most remote areas of the country. The main objective is to increase the attendance rate of women invited for screening in order to improve early detection of breast cancer.

“We are very pleased to work with GE Healthcare as a supplier of the latest mammography technologies,” said Niall Phelan, chief physicist for the BreastCheck program. “Aside from its proven high image quality, the reduced time required by our radiographers to carry out the mammogram and review the images was also a considerable advantage when choosing the Senographe Essential.”

Phelan added, “We are confident that our six GE mobile units will assist us in bringing the screening service to women across a wider geographical area as our breast screening program expands nationwide.”

CE mark for ExAblate 2000

InSightec (Haifa, Israel)reported that its ExAblate 2000 system has received the CE mark for pain palliation of bone metastases. The company said that 100,000 patients in Europe are diagnosed with bone metastases every year. Most cancer patients suffer from pain, so controlling it and managing its symptoms are important treatment goals.

In clinical studies that supported the CE mark certification, patients reported their pain levels using VAS (Visual Analog Score), a pain questionnaire used to monitor changes in pain levels and assess the efficacy of pain management. The majority of patients reported an immediate improvement in pain scores, the company said. Many also reported that they stopped using any analgesic pain relief.

“ExAblate 2000 has been used to successfully treat uterine fibroids non-invasively with magnetic resonance-guided focused ultrasound (MRgFUS) and this second CE mark represents a significant milestone in our quest to expand the potential applications of this non-invasive therapy for oncology,” said Dr. Kobi Vortman, president and CEO of InSightec. “This procedure can alleviate the patient’s pain, has the potential to lower reliance on analgesics and provide patients with the opportunity for improved quality of life.”

The ExAblate 2000 is the first system to use the MRgFUS technology, which combines MRI (to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome) and high-intensity focused ultrasound to thermally ablate uterine fibroid tissue.