• American Bio Medica (Kinderhook, New York) said that they have launched, and have begun shipping, another new point of collection drug test, the Rapid TOX Cup; an all-inclusive drug testing cup. The cup doesn’t require any manipulation of the device; the donor simply voids into the cup. Its wide mouth and larger cup allow for easier specimen collection. A temperature strip is affixed to the cup to ensure specimen integrity, with the option to add a specimen validity test strip. Results obtained with the Rapid TOX Cup can also be photocopied for record keeping purposes. American Bio Medica makes immunoassay diagnostic test kits.
• ArthroCare (Austin, Texas) said that its MD SpineWand is now available for use in some of the most common spinal surgeries. The MD SpineWand is designed to remove soft tissue — including disc material — through small incisions, which avoid damage to surrounding structures and anatomy. The product provides controlled tissue removal with Coblation, a patented technology that uses electrical energy combined with a conductive medium, such as saline solution, to form a plasma that gently and precisely dissolves soft tissue, at relatively low temperatures, minimizing damage to adjacent, healthy tissue. ArthroCare makes minimally invasive surgical products.
• Collagen Matrix (Franklin Lakes, New Jersey) reported launch of its OssiMend bone graft matrix for orthopedic and spine applications. OssiMend is an all-natural mineral-collagen composite bone graft material which, combined with autologous bone marrow, is used to fill bony voids or gaps of the skeletal system, including spine, extremities and pelvis. OssiMend is a composite matrix available in strips, pads, or granular form for surgical implantation. The principle components of OssiMend are type I collagen and anorganic bone mineral. The natural anorganic bone mineral is derived from bovine cancellous and cortical bone. Collagen Matrix makes implants for tissue and organ repair and regeneration.
• CryoCath (Montreal, Canada) reported positive 12-month follow-up data from the second and final cohort of 18 patients treated during the feasibility stage (33 patients total) of its STOP AF (atriall fibrillation) investigational device exemption trial. The results confirm that 14 of the 18 subjects are free of AF, with 12 of the 14 not taking any anti-arrhythmic drug therapy. The trial, now in the pivotal stage, is assessing CryoCath’s Arctic Front catheter to treat AF. Arctic Front is a minimally invasive cryo-balloon catheter designed specifically to treat paroxysmal Atrial Fibrillation. This bi-directional, double-balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. CryoCath makes products to treat cardiac arrhythmias.
• Endocare (Irvine, California) said that a new 5-year retrospective study published in the October issue of the British Journal of Urology demonstrates that cryoablation is an effective treatment for patients with small kidney tumors. In the study, the cancerous lesions were ablated through either laparoscopic or percutaneous cryoablation in one operative procedure in 95% of the cases and, after a mean follow-up of 19 months, the cancer-specific survival rate was 100% and recurrence-free survival rate was 98.7%. The researchers noted that the collaboration between urologists and radiologists is optimal for these patients to best target and guide the ablations. Endocare is focused on the development of minimally invasive technologies used by urologists and interventional radiologists for tissue and tumor ablation.
• Positron (Houston) introduced their new dedicated Cardiac PET system at the annual meeting of the American Society of Nuclear Cardiology. Positron’s new Attrius molecular imaging system incorporates software and hardware technology for the diagnosis and treatment of patients with heart disease. Positron offers a combination of low cost technology and disease specific software solutions differentiating themselves from all other medical device manufacturers.
• Positron also reported that Neusoft Positron Medical Systems (Shenyang, China), has begun preparations for FDA 510(k) submission on the new Attrius PET camera by contracting global regulatory expert TUV to help successfully complete the submission. Neusoft Positron Medical systems has partnered with TUV as a means of insuring success on regulatory affairs on all products including the Attrius PET. Positron makes cardiac molecular imaging devices using single photon emission computed tomography and positron emission tomography.