• GenVec (Gaithersburg, Maryland) completed enrollment in its follow-on Phase I study of its AdPEDF gene therapy in patients diagnosed recently with wet age-related macular degeneration. The clinical trial involves 20 patients who received a single injection of one of two doses of AdPEDF. Study participants will be evaluated at three and 12 weeks to assess changes in their vision and to confirm the drug's safety profile and will then be followed for one year after treatment. AdPEDF is an adenoviral-based vector containing the gene for human pigment epithelium-derived factor.

• Kensey Nash (Exton, Pennsylvania) reported that a low major adverse cardiac event (MACE) rate of 3.2% was achieved in its recent ASPIRE study, which studied the effectiveness of the new TriActiv FX Embolic Protection System to reduce MACE during the treatment of diseased saphenous vein grafts (SVG). The company said that the 3.2% rate is the lowest recorded to date from a sizable multicenter study of the SVG population, and is less than half of the next best data set widely quoted by the cardiology community. The rate of heart attacks in the ASPIRE study, included as part of the MACE rate, was also a low 2.2%, which is a 67% reduction in the rate seen in the next best embolic protection device's data set. The company also noted that procedure times were on average 15 minutes below the control cohort of the other embolic protection systems. The complete data set from ASPIRE will be highlighted during this week's American College of Cardiology conference in Atlanta.

• KeraCure (Chicago), which is commercializing products for the advanced wound healing market, reported that the first patients have been treated in a multicenter pivotal study for the treatment of diabetic foot ulcers. The study was recently approved by the FDA to test the safety and efficacy of the KeraPac device in about 270 subjects in 16 clinical sites across the U.S. The device is comprised of human keratinocytes, grown on microcarrier beads and packaged in a patented dressing configuration. The KeraPac is placed externally on a clean wound and removed several days later. Genzyme (Cambridge, Massachusetts) will manufacture its KeraPac for the study.

• Medtronic (Minneapolis) reported the addition of OptiVol Fluid Status Monitoring trend data available via the Medtronic CareLink Network. OptiVol Fluid Status Monitoring, which measures changes in impedance in the thoracic cavity, is a feature found on the InSync Sentry cardiac resynchronization therapy-defibrillator. Using low electrical pulses that travel across the thoracic cavity, the system can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the chest. Since normal fluid levels may vary from patient to patient and fluid accumulation can be either slow or rapid, OptiVol's ability to measure fluid status trends over time can provide insights that are used in conjunction with ongoing monitoring of other patient symptoms. The company recently received FDA approval to provide this fluid trend data to physicians monitoring their patients via the Medtronic CareLink Network.

• Oculus Innovative Sciences (Petaluma, California) reported that the FDA has granted clearance to market a consumer-specific version of Dermacyn Wound Care as an over-the-counter (OTC) product. The FDA approved the company's OTC product with more limited label claims than Oculus' prescription Dermacyn formula, used for moistening absorbent wound dressings and for debriding and cleaning acute and chronic dermal lesions. The new consumer brand, Dermacyn Wound Care OTC, is intended for general-purpose use, including moistening of absorbent wound dressing and cleaning minor and superficial skin abrasions. The company expects Dermacyn Wound Care OTC to be available for purchase without prescription as early as April.

• Smith & Nephew Trauma (Memphis, Tennessee) reported that the FDA approved a label amendment for Supartz Joint Fluid Therapy. Although Supartz Joint Fluid Therapy is still indicated for five weekly injections, the amendment to the directions for use and the precaution section of the labeling now allow physicians to choose as few as three weekly injections for their patients with osteoarthritis knee pain if the physician judges the patients would experience benefit. Supartz Joint Fluid Therapy was the first hyaluronan joint fluid therapy commercially available for human use in treating osteoarthritis.

• Spacelabs Medical (Issaquah, Washington) reported the availability of a new addition to the UltraviewSL line of patient monitors. The UltraviewSL 2600 is an advanced compact monitor with options that support open standards and connectivity, including WinDNA, which brings workstation functionality for hospital applications to the point of care. The monitor's compact size and larger display, coupled with advanced monitoring features, provide a flexible solution that enables hospitals to augment their existing installation of Spacelabs monitoring. A wireless networking option supports central surveillance during patient transport, enhancing patient safety and improving emergency response time. Together with its new Clinical Event Interface to hand-held devices, these capabilities serve to accelerate the flow of critical, time-sensitive patient information to caregivers, regardless of location, the company said. Spacelabs Medical is a division of Spacelabs Healthcare, a subsidiary of OSI Systems.

• VirtualScopics (Rochester, New York), a developer of image-related biomarkers, said that the company co-authored and presented three studies at last month's International Society for Optical Engineering medical imaging meeting in San Diego. The studies describe the use of automated computerized approaches to measure and evaluate progression of musculoskeletal disease as captured in images from MRI or computed tomography. Among them: a presentation addressing the use of a computer software algorithm to segment and image cartilage degradation and thinning in MR images of rat knees, showed that this automated approach yields similar results to that of using experts to review the images.