• Atrium Medical (Hudson, New Hampshire), a manufacturer of devices used in open heart surgery, emergency chest trauma, thoracic drainage and surgical repair of diseased blood vessels, said it has obtained FDA 510(k) approval for C-QUR Mesh. The bio-absorbable coated surgical mesh product is indicated for use in the surgical repair and reinforcement of soft tissue, including hernia repair. It combines Atrium's ProLite Ultra polypropylene surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbable coating, which has demonstrated in preclinical studies a minimization of peritoneal tissue attachment as well as a significant reduction in both foreign body reaction and inflammation.
• Portland Orthopaedics (Sydney, Australia), a manufacturer of reconstructive orthopedic devices, said it has been granted FDA approval to sell its Beacon Primary Knee System in the U.S. The Primary Knee has been licensed from Signal Medical (Marysville, Michigan) and is used as a first-time knee replacement for patients who are the most likely sufferers of osteoarthritis and rheumatoid arthritis. The company said the implant will relieve pain and increase mobility. Manufacturing of the Beacon Primary Knee has commenced and will be the manufacturing platform for the revision knee, a niche knee product designed for people with poor bone quality who need the greater modularity and fixing capability. The revision knee is currently under development under a $1.9 million AusIndustry grant.
• PreMD (Toronto), focused on predictive medicine, reported that a scientific abstract describing a new microwell-based format of LungAlert has been accepted for presentation at the American Association for Clinical Chemistry annual meeting to be held in Chicago in July. The abstract describes a new test format can be processed using standard, automated laboratory equipment.
• W. L. Gore & Associates (Flagstaff, Arizona) reported the introduction of the Gore Seamguard Bioabsorbable Staple Line Reinforcement configured for open surgical staplers. The first synthetic, bioabsorbable material of its kind is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries, according to the company. It is composed of a copolymer glycolide and trimethylene carbonate microporous structure with an extensive history of safety in sutures, surgical meshes and implantable devices. Thinner and more flexible than other reinforcement materials, the product retains measurable strength for four to five weeks and is completely absorbed within six months. It is configured for quick and easy loading onto the jaws of staplers, and stays in place during insertion through trocars and during tissue manipulation. As the thinnest staple line reinforcement product available, it permits a wide range of tissue thicknesses to be stapled.