• Cambridge Heart (Bedford, Massachusetts), a manufacturer of diagnostic tools to non-invasively measure microvolt levels of T-wave alternans (MTWA), reported the publication in the current issue of The Journal of the American College of Cardiology of a new clinical study titled, “Prognostic Utility of Microvolt T-Wave Alternans in Risk Stratification of Patients with Ischemic Cardiomyopathy.” The study enrolled 768 patients with ischemic cardiomyopathy and an ejection fraction less than or equal to 35% at four outpatient clinics. The authors studied MTWA to discern if it was an independent predictor of mortality, and could therefore identify which of the individuals would be at the highest risk of death and most likely to benefit from implantable cardiac defibrillators (ICD) therapy. The authors commented, “The ability to more selectively target devices [ICDs] in high risk individuals using a screening test such as MTWA might lead to more complete treatment of those who are most likely to benefit.”

• Confirma (Kirkland, Washington), a provider of computer-aided-detection (CAD) for MRI, said that it is showcasing its expanded capabilities for CADstream, the standard in CAD for breast MRI, at the 2006 International Society for Magnetic Resonance in Medicinemeeting currently under way at the in Seattle. Advanced features include morphology characterization through CADstream's volume analysis tool and SureLoc, CADstream's interventional guidance tool. Expanded products include CADalog for instant prior study recall, SureLoc-C for dedicated interventional guidance in the MRI suite and CADstream-C for dedicated diagnostic interpretation at a single-reader breast MRI reading console.

• FzioMed (San Luis Obispo, California) reported the presentation of preclinical studies demonstrating that the company's Oxiplex Gel was effective in reducing perivascular adhesions in artificial disc surgery. The poster presentation is being made at the Spine Arthroplasty Society meeting ongoing through Saturday in Montreal. Oxiplex is an absorbable, injectable gel designed to be applied during surgery, act as a temporary barrier to adhesion formation, and then clear naturally from the body. The preclinical studies compared the effectiveness of Oxiplex Gel in preventing perivascular adhesions after retroperitoneal spine surgery to that of a control group that underwent the same procedure without use of the gel. The results showed that coating the vessels with Oxiplex Gel during the initial surgery significantly simplified dissection in revision surgery by reducing both density and tenacity of adhesions. By contrast, extensive adhesions formed in all controls, between the overlying peritoneum, between the abdominal aorta and underlying vessels and muscles, and between the muscle and spinal column.

• Guava Technologies (Hayward, California), a developer of cell-analysis systems, reported that it has received FDA 510(k) clearance for the Guava EZCD4 system, which includes the EZCD4 Assay, the PCA Instrument and CytoSoft v2.3 Software, incorporating three modules (EZCD4, Guava Check and Clean and Shutdown). The EZCD4 system is intended to identify and quantify absolute counts of CD4+ T-Lymphocytes in EDTA whole blood. Using Microcapillary Cytometry Technology, the system is intended for the ongoing monitoring of patients with documented diagnosis of an immunodeficiency disease. The Guava EZCD4 Assay is a two-color, direct immunofluorescence reagent kit intended for use with a Guava PCA System. The kit consists of a monoclonal anti-human CD3 antibody that uniquely identifies T-cells and a monoclonal anti-human CD4 antibody that allows the identification of human helper/inducer CD4+ T-cells. Testing requires only 10 microliters of whole blood per patient. The Guava EZCD4 System also requires far less reagent per sample, and the microcapillary technology does not require the use of sheath fluid.

• Impliant (Milford, Connecticut), developing spine arthroplasty alternatives to fusion surgery, said it has been awarded two U.S. patents for its spinal implant solutions in posterior motion preservation. U.S. patent No. 6,966,930 is a minimally invasive facet repair system that allows surgeons to implant a spacer between the posterior joints of the spine. The spinal implant device is intended to alleviate isolated facet joint pain due to joint space narrowing. U.S. patent No. 7,011,685 is the basis for Impliant's TOPS System, a three-axes Total Posterior Arthroplasty solution. The TOPS System, an alternative to spinal fusion, is designed to stabilize but not fuse the affected vertebral level after a laminectomy and medial facetectomy to alleviate pain stemming from degenerative spondylolisthesis, spinal stenosis and facet arthrosis.

• Merit Medical Systems (South Jordan, Utah), a manufacturer of proprietary disposable accessories used primarily in cardiology and radiology, reported the introduction of a new safety product called the TriplePlay. The Merit TriplePlay consists of three parts: a covered waste basin to help reduce splashing and spraying of fluid waste, an absorbent catch basin to help retain and absorb blood, and an ancillary tray to hold small tools or gauze pads. After use, the three parts lock together for safe and convenient disposal.

• Oxford BioSignals (Indianapolis), which provides intelligent data acquisition and advanced signal interpretation for medical and industrial sectors, said that the FDA has approved its 510(k) application for BioSign. BioSign, an accessory device to multi-parameter patient monitors, analyzes five vital signs and assigns a patient status index which continuously represents how different a patient's vital signs are with respect to normal patient conditions. BioSign is intended to help healthcare professionals and Rapid Response Teams identify patients in crisis and intervene earlier to correct the problem.

• Sirtex (Lake Forest, Illinois), a developer of targeted cancer therapies, reported the launch of a clinical trial evaluating the use of SIR-Spheres microspheres in combination with the oral chemotherapy Xeloda (capecitabine) for patients with advanced metastatic liver cancers. The trial will be conducted at the Fox Chase Cancer Center (Philadelphia). Sirtex's SIR-Spheres microspheres are the only FDA-approved radioactive microspheres for the treatment of metastatic liver tumors. Xeloda, manufactured by Roche Pharmaceuticals (Basel, Switzerland), is the only FDA-approved oral chemotherapy for metastatic breast cancer, and adjuvant and metastatic colorectal cancer. The trial is designed to determine the safety, toxicity and recommended dose for Xeloda when administered concurrently with SIR-Spheres microspheres in patients with advanced liver cancer. Colorectal cancer that has spread to the liver is the most common type of cancer treated with SIR-Spheres microspheres.