A Medical Device Daily
SpineWorks Medical (San Jose, California), reported receipt of the CE mark, allowing commercialization of its SpineAlign vertebral body replacement (VBR) system in the European Union and all countries recognizing the CE mark.
The company said the SpineAlign VBR system is its first approved product that was designed for a transpedicular, minimally invasive approach to vertebral body reconstruction and anterior spinal column support.
The system was subjected to a series of ASTM tests conducted in accordance with the FDA "Guidance for Industry and FDA Staff: Spinal System 510(k)s" document issued in May 2004.
"We completed all of the recommended biomechanical testing in compliance to the VBR guidance standards and exceeded all recommended loads," said President/CEO Paul Chirico. "Our product development process has incorporated a diligent approach of keeping an eye on the biomechanics that are needed to accomplish this exciting new approach to reconstructing disease and age-compromised vertebral bodies."
Sean Pakbaz, MD, associate professor of radiology and neurointerventional surgery at the University of California San Diego Medical Center and a consultant to SpineWorks, said, "The SpineAlign device, which has surpassed our expectations in both laboratory and cadaveric testing, allows us to work directly through the spine vertebral body pedicle, while at the same time minimizing soft-tissue disruption. Reconstruct[ing] a vertebral body is becoming easier, both for us and for the patient."
He added, "In the delivery of care for spinal diseases, physicians are always looking for more innovative technologies especially those that utilize the latest generations of medical imaging to deliver more effective therapies."
In reporting the European product approval, SpineWorks noted that the treatment of spine disease "is rapidly moving from open surgery toward less tissue-disruptive procedures with the use of better imaging and innovative, minimally invasive devices."
UK medical school in Pronostics deal
Pronostics (Cambridge, UK), a manufacturer of multiplexed diagnostics for healthcare providers and the pharmaceutical industry, reported signing a deal with the University of Birmingham Medical School (UBMS) to provide next-generation autoimmune testing services for its clinical immunology service.
As part of the deal, Pronostics will provide clinical immunology service with its fully automated UltraPlex system and ANA Assay for the diagnosis of autoimmune disease.
This contract follows an independent trial at UBMS in 2007 that compared Pronostics' UltraPlex ANA assay with existing testing methods. The company said the UltraPlex solution "eliminates the possibility of subjective errors, removes non-specific positive results and focuses on clinically significant results, with known disease association. Its introduction will also significantly reduce test turnaround times."
Timothy Plant, laboratory manager for UBMS clinical immunology services, said, "We ... look forward to enjoying the benefits the UltraPlex platform has to offer."
The UltraPlex ANA assay consists of 11 tests in one, providing what the company said is valuable time and cost savings compared to serial testing approaches or current multiplexing methods.
It allows hospitals and laboratories to perform fully automated tests on patient samples and gives both quantitative and qualitative results for antibodies in autoimmune diseases, Pronostics said.
Pronostics said it will be launching assays in the cardiovascular and cancer disease areas over the coming year to supplement its autoimmune line, which currently includes ANA, Coeliac and Thyroid assays.
Mobility aids market expanding
An aging population, recent technological trends and growing societal acceptance of people with disabilities are boosting the demand for mobility aids in Europe, according to a new report from Frost & Sullivan (F&S; London).
European Mobility Aids Markets says that the market had revenues of $1.40 billion in 2007 and estimates that it will reach $1.82 billion by 2014.
The rising need for reliable and innovative mobility aids that will improve the lifestyle of patients will drive the growth of the market, according to F&S Research Analyst Dr. Bejoy Daniel.
"The expansion of managed care and the creation of the diagnosis-related group (DRG) reimbursement system have compelled hospitals to reduce the duration of stay for inpatients," said Daniel. "This has driven the market for homecare, which has shown to be more cost-effective than traditional care. As patients are being discharged from hospitals sooner, the sale of mobility aids for homecare will increase."
The report says the powered wheelchair market has advanced due to innovation and intensifying competition between key incumbents and emerging market participants. "The major challenge for companies will be to create extremely reliable and innovative mobility aids that will tangibly enhance the quality of life of customers," the report said.
"Diversification is the key to success, with several large manufacturers already offering a full line of home medical equipment (HME) and services in order to attract large customers," Daniel said. "HME dealers are asking for products to be bundled for convenience and lower costs. Customers are increasingly indicating their preference for dealing with a single source for HME purchases."
The report said competitive success will depend on efforts to diversify and extend product portfolios.
Roche Applied Science starts supply program
Roche Applied Science (Penzberg, Germany) reported the start of the Roche Prime Supply Program, an on-site stocking program ensuring immediate availability of Roche Applied Science products.
This system provides efficient and economical access to consignment stock stored on site at your facility, avoiding supply and delivery issues and reducing delays in your research. The user obtains the reagents he/she needs at a moment's notice, relying on a user-friendly computerized interface, improved cost savings, and an uninterrupted supply of trusted Roche research products
The system comes with customized real-time inventory with automatic stock adjustments. For each account as well as for individual users, security, reporting and tracking tools are provided.