A Medical Device Daily
Spine solution manufacturer LDR (Austin, Texas) reported receipt of approval in China to market its second-generation Mobi-C cervical artificial disc. The company said this approval strengthens its position in the growing Asian market.
LDR said the controlled mobility of the Mobi-C's mobile insert "encourages restoration and respect of the instantaneous axis of rotation for a return to physiological mobility of the inter-vertebral disc and the cervical spine."
It said the disc's design also eliminates the need for invasive vertebral anchorage, "thus reducing the stresses on the bone-implant interface and facilitating multi-level implantations."
The Mobi-C was first introduced in November 2004 and has been used to treat more than 6,000 patients worldwide.
CEO Christophe Lavigne said, "The Mobi-C is a proven solution for cervical disc replacement with a simple, safe and reproducible surgical technique. The capacity of Mobi-C to be used for single or multi-level application is something I am sure that surgeons will appreciate and that positions us well against our competitors."
He said company subsidiary LDR China, through its offices in Beijing and Shanghai, "is prepared and excited to support the needs of our Chinese surgeon customers."
Tian Wei, MD, a noted spine surgeon and chairman of BJ JST Hospital, China's top cervical disc replacement site, said, "One of the biggest advantages of the mobile bearing technology for surgeons and patients is that no keels or screws are needed for obtaining primary stability. The instrumentation is straightforward and easy to use and the implant's design makes it a good solution for multi-level as well as hybrid interventions."
Health Canada okays DynaChip System
The Invitrogen division of Life Technologies (both Carlsbad, California) reported that its DynaChip HLA Antibody Analysis System has received approval from Health Canada's Medical Device Bureau for the detection and identification of antibodies to human leukocyte antigen (HLA) markers, an essential step in determining the compatibility of organ donors.
HLA markers are proteins found on the surface of certain cells in the body. They are used by the body's immune system to identify material that is foreign, such as viruses or bacteria. HLA antibody identification is important for organ transplant donor-recipient matching because, in the case of organ donation, a patient's immune system may fight cells from the donor, causing organ failure or rejection.
The DynaChip HLA system, which received FDA clearance last year, is the only automated chip-based system for HLA antibody detection and identification.
It consists of the DynaChip Processor, which automates assay processing, including dispensing, incubation and washing to image detection and results analysis; the DynaChip protein array, which allows users to test for multiple antibodies at the same time; and the DynaChip interpretation software, which the company said provides "rapid, efficient and automated analysis."
Jim Janicki, head of clinical diagnostics for Life Technologies, said, "Health Canada has joined a growing list of medical agencies that have approved the DynaChip HLA Antibody Analysis System to help make clinical transplant decisions. This system is an important tool that can help doctors make transplant decisions more quickly and accurately."
Chinese approval for Elekta Compact
Elekta (Stockholm, Sweden) said it has received approval from the Chinese State Food and Drug Administration (SFDA) to sell its linear accelerator Elekta Compact in that country.
The company said the Elekta Compact is a linear accelerator for conventional radiotherapy, configured for countries in need of rapid build-up of additional treatment capacity. The machine is based on a combination of technology from Elekta and from the product platform developed by the Chinese company BMEI, which was acquired by Elekta in 2006.
Elekta said there is a "large potential" for Elekta Compact in China, where there is shortage of high-quality cancer treatment. It said the number of linear accelerators is less than one per 1 million inhabitants and a large part of the existing systems needs to be replaced.
President/CEO Tomas Puusepp said Elekta Compact is the "ideal treatment system" when replacing existing Cobalt units, as the platform allows for further growth and expansion.
Elekta received SFDA approval in May 2008 to export Elekta Compact outside China and in June added CE marking, allowing marketing of the device in Europe, Latin America and Asia.