A Medical Device Daily

Medtronic Sofamor Danek (Memphis, Tennessee) reported that the Australian Therapeutic Goods Administration approved the company's Infuse Bone Graft/LT-Cage, Inter Fix and Inter Fix RP devices for spinal fusion, making the Infuse Bone Graft product available in that country.

The Infuse Bone Graft/LT-Cage device consists of a small, hollow, threaded, tapered metal cylinder and a bone graft substitute. It is designed to restore degenerated disc space to its original height, relieving pressure on the nerves.

During surgical procedures, two of the cages are placed side-by-side. The cages are filled with Infuse Bone Graft material, which consists of recombinant human bone morphogenetic protein 2 (rhBMP-2) and an absorbable collagen sponge (ACS).

The protein, which stimulates bone formation, is a genetically engineered version of a natural protein normally found in small quantities in the body. During surgery, the protein solution is soaked into the ACS. The ACS acts as a scaffold for the formation of new bone. Over time the sponge resorbs in the body.

“Infuse Bone Graft/LT-Cage allows Australian spinal surgery patients access to a treatment that eliminates painful bone graft harvesting [while] at the same time creating a fusion,“ said Dr. Peter McCombe of St. Andrew's War Memorial Hospital (Brisbane, Australia).

Medtronic Sofamor Danek said Infuse Bone Graft is the only bone graft replacement with FDA approval specifically for use in lumbar spinal fusion procedures to treat degenerative disc disease. The product also can make spinal fusion easier on patients by eliminating the traditional bone harvesting from a patient's hip, according to the company.

Aseptic liquid-transfer agreement

Aseptic Technologies (Les Isnes, Belgium) and Sartorius (Goettingen, Germany) have launched a global distribution agreement for an aseptic liquid-transfer system developed by Aseptic Technologies.

The system comprises an optimized transfer port and disposable presterilized connection device, and facilitates risk-free transfer of sterile liquid to and from a contained area.

The companies said the system has been developed to allow transfer of sterile liquid through any type of walls that separate two areas with different levels of containment. Applications include transfer from an external area to a cleanroom, transfer from within a cleanroom to isolators used as barriers or transfer inside incubators.

Benoit Verjans, commercial director at Aseptic, said, “Sartorius has the capabilities, the vision and the experience to make such a technology available to all manufacturers from various areas, such as the pharmaceutical, biotech and food industries.“

Sartorius has exclusive rights to distribute Aseptic Technologies' system on a global basis. The companies plan to co-develop new products based on the connector technology to further expand applications for risk-free liquid transfer.

CTLM results featured at Arab Health

Imaging Diagnostic Systems (IDSI; Fort Lauderdale, Florida) included reports on an array of computed tomography (CT) laser breast imaging clinical results during last week's Arab Health 2006 conference in Dubai, United Arab Emirates. The company presented clinical cases compared to mammography, ultrasound and MRI from a number of sites where its CT Laser Mammography (CTLM) technology is used.

Janusz Ostrowski, vice president of international sales, said of IDSI's involvement in the event: “Through our attendance, we are reinforcing the clinical value of CTLM breast exams to women in the Middle East and supporting our customers in the region.“

Arab Health is the largest healthcare exhibition in the Middle East, with upwards of 28,000 attendees.

The CTLM system is the first breast imaging system that uses laser technology and patented algorithms to create 3-D cross-sectional images of the breast. The non-invasive examination that does not expose the patient to radiation or require breast compression.

Imaging Diagnostic Systems has received CE marking of the system, along with approval in Canada and China. It is seeking FDA premarket approval for use of CTLM as an adjunct to mammography.

MSI cites sales activity in China, UAE

Medical Services International (MSI; Edmonton, Alberta) said it has signed an agreement to start shipping VScan test kits into Anhui Province in China. MSI said the accord with a private hospital in the province covers its test kits for HIV, hepatitis B & C and tuberculosis.

Based on discussions with officials from the hospital, the company said it anticipates that the hospital will require a minimum of 500,000 to 600,000 test kits per year.

MSI also reported that its distributors on site at the Arab Health 2006 conference in the United Arab Emirates had been busy taking orders for VScan products.

Lifeline gets Chinese MastaScope order

Lifeline Biotechnologies (Reno, Nevada) said it has received a $27,000 purchase order for the MastaScope from its Chinese distributor, Shanghai Science Medical Equipment Co.

“This order is the result of what has been a concerted sales effort by Shanghai Science Medical Equipment in introducing the MastaScope to physicians, hospitals and clinics throughout China. We are expecting an increase in orders throughout 2006,“ said Jim Holmes, CEO of Lifeline Biotechnologies.

Shanghai Science Medical Equipment has sales representation in 17 of China's 26 provinces. The MastaScope received approval from Chinese regulatory authorities last year.

Distributor named for Chembio in Tanzania

Chembio Diagnostics (Medford, New York) said it has named Anudha Ltd. to distribute the company's rapid HIV tests in Tanzania. Chembio, whose HIV Stat-Pak Dipstick is part of the national testing protocol in Uganda, established a regional office in Tanzania in June 2005 led by Dr. Jay Drosin.

The company said it believes there will be “a significant scale-up in the demand for rapid HIV tests in Tanzania and other countries in the region that have been ravaged by AIDS.“

Tanzania is one of fifty countries worldwide that is part of the Clinton HIV/AIDS Initiative Procurement Consortium. Chembio said it was recently selected by the Clinton HIV/AIDS Initiative as one of four global suppliers to those countries.