Product Briefs

• Cyberonics (Houston) has stopped shipment and is retrieving field inventory of its Aspire platform generators, Models 105 and 106. The company does not believe that the generators pose a health risk to patients, but initiated this action when it discovered that stimulation output current delivered to patients can be less than the output current programmed by a physician. Instructions will be provided to physicians regarding management of the approximately 118 patients who have been implanted with an AspireHC or AspireSR generator. Cyberonics has also suspended enrollment in its E-36 clinical trial pending resolution of this hardware-related design issue. The VNS Therapy System is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. The system uses a surgically implanted medical device that delivers electrical pulsed signals to the vagus nerve.

• FujiFilm Medical Systems U.S.A. (Stamford, Connecticut) reported the company's entry into the portable ultrasound market with the commercial availability of the Fazone CB. Designed to meet the needs of the point-of-care and mobile healthcare environments, the Fazone CB is a compact unit that produces high-quality images. The Fazone CB features Zone Sonography, a technology that uses signal processing unlike other conventional ultrasound systems. Zone Sonography acquires ultrasound data ten times faster, resulting in less motion artifacts delivering image uniformity at every point, FujiFilm said.

FujiFilm also reported the commercial availability of Synapse Mobility, a zero footprint application that enables access to Fujifilm's suite of Synapse products from hand-held mobile devices, as well as Macintosh- or Windows-based PCs. Using the web browser of their choice, radiologists and referring physicians can now have on-the-go access to the images and information stored in Synapse PACS and Synapse RIS, increasing accessibility to patient information and improving workflow. Synapse Mobility displays high-quality, interactive 3-D images – not just static, Flash files – in any platform that it's accessed. The new application provides radiologists and referring physicians with on-the-go access to the images and information stored in Synapse PACS and Synapse RIS using the Web browser of their choice, increasing accessibility to patient information and improving workflow.

• Medtronic (Minneapolis) said newly published data from a multicenter, prospective trial show that sacral nerve stimulation using Medtronic InterStim Therapy reduced incontinent episodes and increased quality of life in a majority of patients with chronic fecal incontinence at three years of follow up. The FDA recently approved the minimally invasive therapy for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. InterStim Therapy uses an implantable system, consisting of a thin wire lead and a neurostimulator, or pacemaker-like device, as well as external clinician and patient programmers. Physicians who implant InterStim therapy for bowel control include colorectal surgeons, urologists, gynecologists and urogynecologists who receive appropriate training.

• Restoration Robotics (Mountain View, California) reported the treatment of the first commercial patient using the ARTAS System, a physician controlled, interactive, computer-assisted technology that allows safe and effective follicular unit extraction (FUE). The ARTAS was developed in close collaboration with several leading hair restoration physicians to enable minimally invasive harvesting of hair follicles. Restoration Robotic is dedicated to revolutionizing the field of hair transplantation by developing and commercializing its image-guided ARTAS System. This interactive, computer assisted system uses image guided technology to enhance the quality of hair follicle harvesting for the benefit of physicians and their patients, the company said.

• NovaBone Products (Jacksonville, Florida) reported the introduction of MacroPor-Si+ to its portfolio of biologically active bone graft substitutes. NovaBone Products makes bone graft substitutes based on advancements in biomedical engineering that meet the specialized needs of both orthopedic and dental surgeons. MacroPor-Si+ was developed to serve as a moldable material that can be fitted to the size and shape of the grafting site. The main component of the device is a calcium phosphosilicate having a continuous macroporous structure. This material is suspended in a rapidly-absorbable binder. The open structure of the porous component allows for rapid vascularization and mineralization. With time, the device is completely absorbed and replaced by new bone.

• Resonance Health (San Diego) has received FDA clearance to market its MRI-Q system. The test measures cardiac T2 which is a highly sensitive surrogate marker for cardiac iron. Iron overload can occur in patients who are dependent on blood transfusions for the treatment of conditions such as thalassemia, sickle cell disease and myelodysplastic syndrome. It can also be caused by excessive dietary absorption of iron through hereditary hemochromatosis, one of the most common genetic disorders in the United States. Iron overload can result in organ damage and the accumulation of cardiac iron is the leading cause of death in patients with ß-thalassemia major. The MRI-Q system is provided to the market as a combined service for both the liver and cardiac T2 iron assessment.