BB&T Staff Writer and Staff Reports

A new wound-dressing product developed by a researcher at Tel Aviv University (TAU; Tel Aviv, Israel) has the potential to dramatically reduce the number of severe burn victims who die from related infections, according to an organization called American Friends of Tel Aviv University (AFTAU; New York).

Prof. Meital Zilberman of TAU's Department of Biomedical Engineering has developed a new wound dressing based on fibers she engineered – fibers that can be loaded with drugs like antibiotics to speed up the healing process, and then dissolve when they've done their job. A study published in the Journal of Biomedical Materials Research – Applied Biomaterials demonstrates that, after only two days, this dressing can eradicate infection-causing bacteria.

The new wound dressing, which AFTAU says does not have a formal name yet, is designed to mimic skin and the way it protects the body. It combines positive mechanical and physical properties with what medical researchers call “a desired release profile of antibiotics,“ the organization noted.

According to Zilberman, the new dressing protects the wound until it is no longer needed, then it melts away.

“We've developed the first wound dressing that both releases antibiotic drugs and biodegrades in a controlled manner,“ Zilberman said. “It solves current mechanical and physical limitations in wound-dressing techniques and gives physicians a new and more effective platform for treating burns and bedsores.“

Noting the need for such wound dressings, Zilberman said in an email response to questions that 75% of the people who die from burns die because of the infection, not the trauma.

“We developed this wound dressing as a part of a large platform of drug-eluting fibers that can be used for many applications. This is just one application,“ Zilberman said.

But the technology is not as simple as it sounds.

Skin, Zilberman says, serves a number of vastly different purposes. “Wound dressings must maintain a certain level of moisture while acting as a shield,“ she says. “Like skin, they must also enable fluids from the wound to leave the infected tissue at a certain rate. It can't be too fast or too slow. If too fast, the wound will dry out and it won't heal properly. If too slow, there's a real risk of increased contamination.“

Zilberman explained that after applying the product on the wound it is filled with fluids from the wound and the antibiotic molecules are released in a rate that decreases with time – large quantities during the first day in order to prevent initial infection due to contamination, and smaller quantities afterwards. Then it dissolves with time to non-toxic end products, she said.

Because the dressing dissolves, removal is not painful for the patient, Zilberman said. She also noted that it can be used for any type of wound, including burns and pressure sores.

“It can be predesigned for the specific application. Its porosity and physical properties such as water uptake can be predesigned so as to fit the specific type of wound,“ Zilberman said.

Elsewhere in the product pipeline:

• Avioq (Research Triangle Park, North Carolina) has received FDA approval for the Avioq HIV-1 Microelisa System. The test is used for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human specimens collected as serum, plasma, dried blood spots, or oral fluid specimens obtained with the OraSure HIV-1 Oral Specimen Collection Device. Avioq claims it is the only HIV-1 Microelisa System to have FDA approval for the qualitative detection of antibodies in oral fluid specimens. The Avioq HIV-1 Microelisa System is intended for use as an aid in diagnosis of infection with HIV-1. The Avioq HIV-1 assay features a microplate design with color-coded, liquid, ready-to-use reagents. The assay volume and incubation time are suitable for automation. This assay demonstrated sensitivity and specificity in clinical studies used for approval.

• Caliper Life Sciences (Hopkinton, Massachusetts) has introduced Living Image 4.0 software for IVIS in vivo imaging systems. Living Image software drives the more than 800 Caliper IVIS systems currently installed in laboratories worldwide. Living Image 4.0 features advanced spectral unmixing tools to enhance fluorescent sensitivity and automated 3-D image acquisition and analysis providing an anatomical view of disease activity and drug efficacy. Caliper says the software's new design creates an intuitive, seamless workflow for researchers of all skill levels. New features include: wizard based guidance for advanced imaging protocols, improved surface tomography, advanced spectral unmixing tools, new color templates and 3-D visualization tools. All IVIS systems are calibrated to NIST standards to ensure that quantitative results are validated throughout an experiment and from location to location.

• Cardium Therapeutics (San Diego) said that its wholly-owned subsidiary, Tissue Repair, submitted a 510(k) premarket notification filing with the FDA seeking marketing clearance of its Excellagen product candidate based on positive data from the company's completed Phase 2b Matrix clinical study. The submission with the FDA covers ExcellagenXL and ExcellagenFX, advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by healthcare professionals for patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds.

• CellaVision (Lund, Sweden) has received FDA clearance for its new analyzer CellaVision DM1200 in the U.S. The product is intended to replace manual microscopy of blood samples and is aimed at medium-sized hospital laboratories as well as independent commercial laboratories. The distribution between different types of blood cells and their appearances are important criteria in the diagnosis of a number of conditions such as infections and blood diseases. Automated technology permits to increase productivity, reduce response times, and improve diagnostic quality.

• CoActiv (Ridgefield, Connecticut) reported upgrades to its EXAM-3D Suite at RSNA 2009. A new feature is EXAM-3D Colonoscopy, an optional add-on module for the analysis and assessment of colon nodules. It provides instant colon fly-throughs with a single click, along with precise axial coronal and sagittal views clearly identified by directional cursor indicators. The specialized application also offers identification of hard-to-locate nodules, including full analysis and volume measurements. EXAM-3D Vascular now includes vessel plaque analysis of hard and soft plaque to support stent planning. Also enhanced are vessel centerline creation and bone removal segmentation. The new EXAM-3D Lung module supports analysis and assessment of lung nodules with automated identification of even difficult-to-find nodules. Regions of interest are analyzed with a single click and can easily be compared with prior images for monitoring over time.

• MAKO Surgical (Ft. Lauderdale, Florida) reported the commercial availability of the Lateral Unicompartmental Knee Resurfacing Application for its RIO Robotic Arm Interactive Orthopedic System. The new application complements MAKO's existing unicompartmental and bicompartmental knee applications targeting the medial and patellofemoral compartments. The RIO is a surgeon-interactive tactile surgical platform that incorporates a robotic arm and patient-specific visualization technology and prepares the knee joint for the insertion and alignment of MAKO's resurfacing Restoris implants through a minimal incision.

• McKesson (Atlanta) has unveiled the latest version of its comprehensive Horizon Cardiology cardiovascular information system designed to automate and simplify cardiologists' complex workflows. The modular, single-platform offering eliminates equipment redundancies and encourages the adoption of structured reporting techniques. McKesson says that complete integration of Fractional Flow Reserve (FFR) into the hemodynamic module is another example of the parallel workflows included in the new software release. FFR is a technique used by many physicians to determine the severity of narrowed blood vessels.

• Merge Healthcare (Milwaukee) reported the availability of its RIS, PACS and Disaster Recovery solutions that leverage a cloud computing platform to manage a breadth of healthcare information. This scalable software as a service (SaaS) by Merge enables digital imaging enterprises to deploy a HIPAA-compliant medical imaging solution without the cost or complexity of managing multiple layers of hardware or software. The cloud-hosted solutions also enable rapid implementation of a RIS (radiology information system) or PACS (picture archiving communications system); allowing practices a faster return on investment and minimal disruption to workflow. A pay-per-study model provides affordable access to the newest releases of Merge's digital imaging software solutions, including the recently released no-client FusionWeb Clinician Access Portal and Fusion RIS 4.0 with Fusion Billing. Hosted on a secure, off-site private server, these robust platforms store digital images (including prior studies) and associated patient information in a fully managed server environment, and are accessible at any time from any hosted network computer.

• Orthofix International (Boston) reported that its sports medicine division, BREG, has expanded its successful line of Fusion functional knee braces by introducing the Fusion Lateral OA Brace, which features an ultra-thin low-profile hinge designed for individuals suffering from lateral compartment osteoarthritis (OA). The Fusion Lateral OA Brace was developed to off-load knee stress for individuals suffering with osteoarthritis, and the low-profile hinge is designed to reduce interference during the wearer's movement specifically on the inside, or medial, part of the knee. As the newest member of the Breg family of Fusion functional knee braces, the new Lateral OA Brace is designed to provide support for the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), as well as protection for collateral ligaments, without hindering the wearer's activity.

• Spectranetics (Colorado Springs, Colorado) has received FDA clearance for its new VisiSheath dilator sheath device. The VisiSheath may be used alone as an independent sheath for dilating tissue surrounding cardiac leads, or as an enhanced outer support sheath in conjunction with compatible inner sheaths such as Spectranetics' Laser Sheath (SLS II), a laser-based system for removing problematic pacing and defibrillator leads. Spectranetics says the VisiSheath device uses unique gold-coated steel marker bands to provide physicians with more than 200% better fluoroscopic visibility of the device tip than standard Teflon or polypropylene sheaths. An advanced multi-layer construction and robust tip design deliver high performance for navigating over leads and dilating tissue.