BB&T

Plastic surgeons and other physicians who treat burn victims have a new kind of adhesive available for attaching skin grafts. Artiss, a slow-setting fibrin sealant developed by Baxter Healthcare (Deerfield, Illinois), enables the delayed setting and controlled manipulation of skin grafts for about 60 seconds, relative to rapid-setting fibrin sealants, which are fixed in five to 10 seconds, according to the company.

Baxter says that these skin grafts can be attached with Artiss without the use of staples or sutures, thus helping to reduce post-operative complications and patient anxiety about pain during staple removal.

"Artiss enables surgeons time to manipulate skin grafts, which allows for greater control and precision in placement of skin grafts," Laura Grossmann, a spokeswoman for Baxter, told Biomedical Business & Technology. "Fast-setting fibrin sealants — which are the only ones on the market to date — do not have the capacity for a prolonged setting time. Artiss is the only fibrin sealant approved for the adherence of skin grafts in burn patients; other fibrin sealants are not approved for this specific use."

Fibrin sealants are made of proteins fibrinogen and thrombin, which are essential in blood clotting. Artiss contains a lower concentration of thrombin, which is what enables the slow set feature of this adhesive.

Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots. Fibrinogen and thrombin proteins in Artiss are derived from human plasma, collected from plasma centers.

"Baxter is committed to patient safety. The fibrinogen and thrombin proteins in Artiss, derived from human plasma, are collected from FDA-licensed plasma centers," Grossmann said. "Both proteins undergo purification and virus inactivation treatments to reduce the risk of blood-transmissible infections."

The FDA approval is based on Phase III study results, published in the March/April 2008 issue of The Journal of Burn Care and Research. The multi-center, prospective, randomized, controlled and blinded study compared the use of Artiss to staples in 138 burn patients requiring skin grafting. The study found that Artiss is safe and effective for attaching skin grafts with outcomes as good as staple fixation.

Frequent adverse events, seen in both treatment groups in the study, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures.

Artiss will be available in two forms: a pre-filled syringe (frozen) formulation and a lyophilized form. Both dosage forms, once prepared and ready to use, can be sprayed, enabling application in a thin and even layer.

There are about 500,000 burn injuries a year in the U.S. each year, according to the American Burn Association (). Of those about 25,000 require a skin grafts, which is the potential market size for Artiss, Grossmann said.

Fibrin sealants are not new to the market and have been used in a variety of other applications.

For example, the FDA recently expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Evicel is sprayed or dripped on small, oozing blood vessels. Evicel is made by Omrix Biopharmaceuticals (Kiryat, Israel).

Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery.

In the same space, Ethicon (Somerville, New Jersey) reported that the FDA granted an expanded indication for Evicel Fibrin Sealant, indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical (MDD, Jan. 14, 2008).

But Artiss is different from other fibrin sealants. In fact, the FDA published its own announcement about the Artiss approval, a move that's typically reserved for important or breakthrough product approvals.

"The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research. "The approval also provides an additional choice for healthcare professionals in providing burn treatment."

Grossmann said Baxter is still evaluating the final pricing for Artiss, as well as a clinical development program for other indications.

Elsewhere in the product pipeline:

• Abiomed (Danvers, Massachusetts) reported receiving conditional approval from the FDA to begin its Impella 2.5 circulatory support system study in the U.S., under an investigational device exemption, for hemodynamically unstable patients undergoing a percutaneous coronary intervention (PCI) procedure due to acute myocardial infarction (AMI), or heart attack. The AMI shock study will determine the safety and effectiveness of the Impella 2.5 as a left ventricular assist device for heart attack patients, as compared to optimal medical management with an Intra-Aortic Balloon Pump. There are estimated over 100,000 AMI anterior infarct patients annually in the U.S. These patients suffer failure of the left ventricle, the large main pumping muscle of the heart. Abiomed makes devices that provide circulatory support to acute heart failure patients.

• Aethon (Pittsburgh, Pennsylvania) said that it has significantly enhanced the navigation system of its TUG robotics platform with the addition of laser-based technology. The new laser-driven navigation system will enable hospitals to deploy TUGs in less time and benefit from speedier deliveries, more flexible routes and requires less technical support. The TUG is an autonomous mobile robotic system that automates the delivery and tracking of materials in hospitals such as medications, dietary trays, linens, blood samples, medical records, or IV pumps. It helps hospitals streamline supply chain operations so that nurses and clinical staff avoid making supply runs and remain focused on patient care. Aethon makes autonomous mobile robots for healthcare supply chain management.

• Affymetrix (Santa Clara, California) reported commercial launch of its complete Cytogenetic solution, which it says combines the high-density SNP Array 6.0 with a simple assay and intuitive software. The microarray-based solution provides cytogenetic researchers with an efficient method of detecting chromosomal abnormalities associated with congenital diseases such as autism and mental retardation. The solution was designed to discover more causative aberrations across the entire genome compared to other microarray platforms and karyotyping techniques. The solution delivers copy number and loss of heterozygosity information, which enables research scientists to identify uniparental disomies, genetic abnormalities that are frequent in many congenital diseases.

• Alcon (Washington) released the primary efficacy and safety results of the second controlled proof-of-concept clinical study of anecortave acetate administered as an anterior juxtascleral depot in the sub-Tenon's space to reduce intraocular pressure in patients with open-angle glaucoma. Prior to enrolling in the study, all patients had been diagnosed with open-angle glaucoma, had confirmed visual field changes and had off-therapy intraocular pressures (IOP) between 24 mmHg and 36 mmHg. One injection of drug or vehicle was administered to each patient and intraocular pressures were assessed at two weeks, six weeks and at month three, with month three predefined as the visit for primary efficacy. Alcon is an eye care company.

• Angiotech Pharmaceuticals (Vancouver, British Columbia) said that the clinical data from its 960-patient clinical trial comparing its 5-Fluorouracil-coated (5-FU) central venous catheter (CVC) with a chlorhexidine/silver sulfadiazine- (CH-SS) coated CVC was presented by the clinical investigators at the 28th International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels, Belgium. Based on the trial data, investigators concluded that Angiotech's 5-FU CVC met the primary endpoint of the study: non-inferior in its ability to prevent bacterial colonization of the catheter tip when compared to catheters coated with CH-SS. The principle behind using 5-FU on a CVC is that the drug acts through multiple pathways to inhibit bacterial growth and metabolic functions of most microorganisms. Adding a very minute amount of 5-FU to the surface of a device makes that surface a very hostile environment for a microorganism, with unchanged tolerability for the patient. Angiotech is a specialty pharmaceutical and medical device company.

• AtriCure (West Chester, Ohio) reported that its Coolrail linear ablation pen received FDA clearance for the ablation of cardiac tissue. Additionally, the first patient was treated using the pen. The Coolrail linear ablation pen is designed to facilitate the creation of an expanded cardiac ablation lesion set during a minimally invasive off-pump procedure. The ORLab system is a mapping, recording and stimulating system which enables electrophysiologists and surgeons to confirm, in the operating room, that the cardiac ablation lines being created are forming electrical barriers, or lines of conduction block. AtriCure makes cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue.

• ArthroCare (Austin, Texas) reported the launch of the ReFlex Ultra PTR Plasma Wand designed for use in volumetric turbinate reduction procedures to treat nasal airway obstructive disorders, such as turbinate hypertrophy in allergic rhinitis for pediatric patients. The Reflex uses Coblation technology to remove and/or shrink turbinate tissue but is designed with a sharpened lead electrode with a shorter, smaller diameter shaft. The wand allows easy entry into turbinate tissue with increased accuracy while reducing visual obstructions typical when treating the smaller anatomy of pediatric patients, the company said. Coblation is gentle radiofrequency energy with a saline solution to remove soft tissue. Coblation works by breaking the molecular bonds, thereby leaving surrounding healthy tissue intact unlike conventional electrosurgery and laser surgery, which rely on high levels of heat. In turbinate reduction procedures, this lower-temperature technique allows for removal of target tissue without damaging surrounding tissue or altering the critically important nasal mucosal lining preserving normal nasal function and leaving facial growth unaffected. ArthroCare makes minimally invasive surgical products.

• Beckman Coulter (Fullerton, California) has launched the UniCel DxC 880i Synchron Access clinical system, an integrated work cell which consolidates chemistry and immunoassay testing targeted to high-volume laboratories. The latest addition to the company's work cell family combines Beckman Coulter's chemistry system, the UniCel DxC 800, and the industry's highest-throughput immunoassay system, the UniCel DxI 800. From a single point of sample entry, the UniCel DxC 880i offers a menu of more than 150 different chemistry and immunoassay tests — with 120 onboard — ranging from cardiac and tumor markers to tests for renal function and more. The system can process up to 1440 chemistry tests per hour and up to 400 immunoassay tests per hour. Beckman Coulter makes products that simplify, automate and innovate complex biomedical tests.

• BioElectronics (Frederick, Maryland) reported launch of its breast recovery kit, ActiPatch, for the relief of edema and post-operative discomfort. The one-day breast recovery kit allows breast surgery patients to return to active lives the day after surgery. ActiPatch relieves edema and discomfort without drugs, ice, or topical ointments, according to the company. ActiPatch is an anti-inflammatory patch with an embedded, battery-operated microchip that delivers weeks of continuous pulsed therapy.

• Biolase Technology (Irvine, California) said that its Waterlase and Waterlase MD laser systems is the first laser systems to receive FDA clearance for root canal disinfection after endodontic instrumentation. "Being able to use a laser that is safer, faster and more effective than conventional chemical disinfectants to treat a condition that affects tens of millions of individuals/year is a true advancement for our profession," said James Jesse, DDS, assistant professor at Loma Linda University School of Dentistry (Loma Linda, California). "In my experience, practitioners can perform the root canal procedure with superior results using the laser and may save as much as 20 to 30 minutes per procedure — a strong clinical and economic argument for using the technology." A root canal is used to eliminate infection and save a tooth that is painful, badly decayed and infected. During the procedure, the nerve and pulp is removed and the inside of the tooth is cleaned, disinfected and sealed. Biolase makes dental lasers.

• Bridge Medical (St. Paul, Minnesota) has introduced two new products, the Telescoping Grip and Telescoping Pivot Grip, offering two portable alternatives when permanent grab bar installation is not possible, or is unnecessary due to a temporary need. Both products come in two sizes, each with the ability to adjust to varying lengths, accommodating the specific needs of the user in any size application area. Two commercial-grade, 4.7-inch diameter grips apply to smooth, flat, non-porous surfaces and feature suction technology, manufactured with non-corrosive metal components

• Celerus Diagnostics (Denver) reported the launch of a new system, the Wave, at the annual meeting of the U.S. and Canada Academy of Pathology (USCAP; Augusta, Georgia). Capable of producing immunohistochemistry (IHC) results in 15 minutes, the Wave accelerates lab throughput, enabling intra-operative testing, and providing real-time pathology to requesting physicians, the company says. By repeatedly opening and closing slide segments, "Dynamic Replenishment Technology" creates kinetic "waves" which mixes and refreshes reagents. This recharging process continuously floods antigenic sites on the tissue with new waves of primary and secondary reagents, providing more efficient biding, accelerating reaction times, and enabling 15-minute IHC turnaround times. Celerus develops cancer diagnostics.

• ContraVac (Chalottesville, Virginia) reported FDA approval of its SpermCheck Vasectomy, a simple diagnostic which confirms men's post-vasectomy sterility. The device will enable men to test their post-vasectomy fertility status at home rather than requiring the patient to return to the physician's office or a laboratory. SpermCheck is a device similar to a home pregnancy test for women. It is the first test with the sensitivity and specificity required to detect low numbers of sperm and the first at-home diagnostic to receive FDA approval for sperm testing after vasectomy, the company says. Physicians will be able to provide SpermCheck Vasectomy to their patients following their vasectomy or men can purchase SpermCheck Vasectomy directly from the company. ContraVac specializes in making reproductive/fertility devices.

• Cook Medical (Bloomington, Indiana) has been granted FDA clearance for the Celect vena cava filter. The Celect is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava and now can be optionally retrieved when clinically indicated. The filter is an implanted metal device used to capture hazardous blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. Using a conical shape, the Celect has a strut design that improves centering in the vessel and reduces in-growth except at the desired attachment points. Cook Medical specializes in the implantable vena cava filter market.

• Covidien (North Haven, Connecticut) said that its surgical device unit has introduced three access products: VersaStep Plus 15 mm, Visiport Plus with fixation, and Versaport Plus RPF 15 mm with fixation. VersaStep Plus 15 mm is a bladeless laparoscopic access system with a radially expandable sleeve minimizing the fascial defect and reducing the downward insertion forces associated with normal trocar insertion. Proven Step technology is designed to enhance patient safety, saves time in surgery and reduces complications, including vascular and visceral injuries. The VersaStep Plus 15 mm complements the existing VersaStep Plus line and offers the benefits of Covidien's Step technology. Covidien makes product lines in four segments: medical devices, imaging solutions, pharmaceutical products and medical supplies.

• CryoCor (San Diego) reported the publication of a study on the treatment of atrial fibrillation (AF) using the company's Cryoablation system. The study concluded that, using its system, pulmonary vein isolation benefited 82% of patients with recent onset paroxysmal AF xxxxxx up averaging 33 months. This is the first and only study to be published that reviews safety and long-term efficacy of AF ablation using cryotherapy, or extreme cold, the company said. It said the study demonstrated an excellent safety profile with no occurrences of pulmonary vein stenosis or esophageal injury, two serious complications that can occur during AF ablation with radio frequency, or other heat-based, ablation devices. CryoCor makes products for the treatment of cardiac arrhythmias.

• DJO (San Diego) reported that its surgical division, DJO Surgical, received FDA clearance for its new X-alt highly cross-linked polyethylene liner for DJO Surgical's FMP acetabular hip system. The FMP acetabular system combines the company's Cobalt-Chrome and ceramic femoral heads with a new wear-resistant, highly crosslinked polyethylene cup liner to form the hip ball and socket joint. This crosslinked polyethylene liner increases the resistance to ball and socket wear compared to traditional polyethylene cup liners, DJO said. The company makes products for pain management and musculoskeletal and vascular health.

• Edwards Lifesciences (Irvine, California) reported the first three human implants of its transcatheter aortic heart valve. Edwards' balloon-expandable pericardial tissue valve features a cobalt chromium alloy frame that reduces the profile by four to five French. This enables easier access into and within the patient's vasculature for delivery of the valve without open-heart surgery. The new valve will also be offered in additional sizes. Edwards specializes in the development of heart valves.

• EKOS (Bothell, Washington) a specialist in the field of microsonic accelerated thrombolysis (MAT), has introduced a new endovascular device that is 29 cm (roughly 30%) longer. MAT uses microsonic energy in combination with thrombolytic drugs to safely speed up the process of dissolving blood clots. The 135 cm offers more flexibility when selecting an access approach to a clot, particularly with taller patients. "Physicians had requested development of a longer device and this opens the door to treating more people," said Robert Hubert, EKOS president/CEO. "Clots don't always form in easy-to-reach places and the 135 cm significantly increases access to distal sites."

• Falcon Electric (Irwindale, California) introduced its FH Series Biomedical and Laboratory-Grade uninterruptible power systems (UPS), designed for the power requirements of biomedical and laboratory equipment. Intended to protect valuable tests and scientific processes, the FH Series 3 to 10kVA UPS assure a high level of power required by analyzers, sequencers, diagnostic equipment and gas chromatography/mass spectrometer instrumentation, as well as other testing and computerized processing equipment. The company said that the FH Series' on-line design provides "clean, tightly regulated power" that assures the highest level of protection for a wide spectrum of scientific equipment from forensics and hospital biomedical labs to semiconductor production, robotics and uranium fuel processing.

• Globus Medical (Audubon, Pennsylvania) introduced its Niko corpectomy spacer system that uses three saggital profiles within the implant system, each which contain at least nine preset heights. The resulting lordosis is contained in the endplate angles and within the shape of the implant itself, enabling surgeons to match the natural anatomy of the body. This feature allows Niko to be immediately implanted, compared to multi-step competitive systems, by eliminating the assembly time of stackable cages or the cutting required with mesh cages. Globus specializes in making spinal implants

• iCAD (Nashua, New Hampshire) reported the availability of the TotalLook MammoAdvantage system which converts prior mammography films to digital images for comparative review on a single digital review workstation. The company said that this new version of its film digitizing solution offers "improved image quality, enhanced image customization options and workflow efficiency features." TotalLook MammoAdvantage's new DigitalLook and PremiumLook image outputs closely match digital mammography images offering enhanced tissue visualization, higher contrast and better edge definition to improve comparative reading. TotalLook MammoAdvantage's software offers configurable image resolution settings that display the digitized images at the same resolution as the digital mammography images, enabling the digitized and newly acquired digital images to be displayed at the same size. The software provides flexible DICOM connectivity solutions for seamless integration with leading review workstations, PACS and RIS systems. iCAD makes computer-aided detection solutions for the early detection of cancer.

• Immunicon (Huntingdon Valley, Pennsylvania) said the FDA has cleared the CellSearch Circulating Tumor Cell (CTC) Kit as an aid in the monitoring of patients with metastatic prostate cancer. A sample of the patient's blood is processed with the CellSearch Kit using the CellTracks System to capture and count CTCs. This clearance represents another expansion to claims for the kit, which is now cleared for three of the four most prevalent cancers. According to the American Cancer Society (Atlatna) prostate cancer claims roughly 27,000 lives each year, the vast majority the result of recurrent metastatic disease that occurs when tumor cells spread to other locations in the body. Immunicon makes cell-based and molecular-based diagnostic and life science research products with an initial focus on the management of cancer.

• Innocoll (Ashburn, Virginia) reported that the second of a series of Phase II trials sponsored by its subsidiary Innocoll Technologies to investigate CollaRx Bupivacaine Surgical Implant for the management of post-operative pain, has begun dosing. The implant is a biodegradable and bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine, formulated using Innocoll's CollaRx sponge technology. It is under development in the U.S. and Europe for the management of post-operative pain following moderate/major ab-dominal, gynecological, abdominal, thoracic, and orthopedic surgeries. Innocoll's implant is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The implant can be placed directly into the surgical cavity and at different layers within the wound, enabling localized treatment of both the incisional and deep, visceral pain components associated with moderate and major surgery.

• Iomai (Gaithersburg, Maryland) reported positive interim results from the 500-subject Phase 1/2 trial of its immunostimulant adjuvant patch used with an injected vaccine for H5N1 influenza. The trial met a key endpoint, demonstrating a clinically relevant adjuvant effect when the Iomai patch was used with a single dose of the 45-microgram H5N1 vaccine. The trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai patch, was sufficient to provide an immune response considered protective in 73% of those tested, a statistically significant improvement over those who received the H5N1 influenza vaccine alone. With further testing, the company says that the patch has the potential to be used in conjunction with other injected pandemic influenza vaccines. Iomai makes vaccines and immune system stimulants.

• Isolagen (Exton, Pennsylvania) reported completion of enrollment of around 120 patients in its Phase II/III study IT-A-008 investigating Isolagen Therapy for treatment of moderate to severe acne scars. The Isolagen Process is a cellular processing system which creates a natural, living cell therapy. By multiplying a patient's own collagen-producing cells or fibroblasts into tens of millions of new cells, a personalized treatment is created which is then returned to the patient's skin. This treatment is designed to improve skin damage caused by the normal effects of aging, sun damage, acne and burns. Isolagen is an aesthetic and therapeutic company.

• LifeNet Health (Virginia Beach, Virginia) introduced the VertiGraft VG1 Cervical Bio-implant, saying it is engineered for anterior cervical fusion surgery to treat neck pain and cervical pathologies. Bio-implant was co-developed by LifeNet and DePuy Spine (Raynham, Massachusetts), and exclusively represented in the U.S. by DePuy Spine. Michael Hobert, LifeNet's VertiGraft product manager, said, "Many surgery centers and hospitals do not have access to the ultra low-temperature freezers needed to store frozen allograft. VG1 Cervical is freeze-dried so it can be stored at room temperature giving ... convenient, room-temperature storage combined with the very high quality standards they demand." LifeNet is a developer of allograft bio-implants.

• Life Spine (Hoffman Estates, Illinois) said the FDA has given 510(k) marketing clearance to Lynx, a new cross-connector system designed for use in surgical lumbar fusion procedures. Life Spine President/CEO Michael Butler indicated that Lynx's new design will allow a surgeon more options when performing lumbar spine surgery and presented with a need for a stabilizing cross connector system. "The Lynx represents another great product development accomplishment for Life Spine. The cross connector provides multi-axial adjustability in all planes and is simple to use, as it snaps onto the rods, self-adjusts and locks with a single instrument. What's more, we have developed both straight and pre-arched versions of the Lynx, providing more tissue sparing surgical options." Lynx features a variety of lengths via its fenestrated design, with straight and arched versions available in an assortment of adjustable length configurations ranging from 25 mm to 100 mm. Lockup of the construct at both rods and at the cross connector's medial joint is accomplished with a single driver tool, which is designed to lock the implant at a predetermined force. Life Spine manufactures spinal implants and instruments for orthopedic and neurosurgery procedures.

• Masimo (Irvine, California) reported that a clinical study published in the Journal of Emergency Medicine found its Rainbow SET Rad-57 Pulse CO-Oximeter to be "a safe, easily applied tool at triage that can identify cases of unsuspected elevated levels of carbon monoxide (CO) poisoning" otherwise undetected. The research team said that identification of CO toxicity in the ED is challenging because many patients may not know or suspect that they were exposed to CO and are unable to provide clinicians with sufficient history to prompt testing for carboxyhemoglobin (COHb). missing the opportunity to diagnose CO poisoning at the ED because screening large populations of patients by invasive blood testing for CO toxicity is not practical and not routinely performed in the ED setting can lead to "inadvertently returning a patient to the site of CO exposure and may lead to further toxicity with the possibility of long-term neurological, psychiatric or cardiovascular complications." Masimo bills itself as the company which invented Pulse CO-Oximetry and Measure-Through-Motion and Low Perfusion Pulse Oximetry.

• Maximus (Ontaio, California), a business unit of infusion therapy firm Medegen, introduced its MaxPlus clear positive displacement connector. MaxPlus provides visualization of the fluid path to give a visual reminder to completely perform clinical practices such as priming, disinfection and flushing in order to reduce bloodstream infections and occlusions in patients receiving infusion therapy. The MaxPlus Clear is an enhancement of the MaxPlus, the company's positive displacement connector, adding a clear housing. It features Medegen's positive displacement technology, which provides a bolus of fluid to clear the catheter tip upon disconnection from the device, and Medegen's Tru-Swab top which acts as a double-seal barrier to contamination and allows for true disinfection during pre-access swabbing.

• Medtronic (Minneapolis) reported the first human use of its investigational bifurcation stent. The new stent uses a Y-shaped design to match the anatomy of lesions that form at the junctions of coronary arteries. The BRANCH study is designed to assess the safety and deliverability of the Medtronic stent, which provides scaffolding to both branches of the bifurcation simultaneously without overlapping stents. Primary endpoints include cardiac death, myocardial infarction involving the target vessel, and clinically-driven target vessel revascularization 30 days post-implant. The bifurcation stent is intended to reduce the challenges associated with current two-stent bifurcation techniques, requiring two overlapping stents, one for the main branch. Delivered over a dual-wire delivery system through a single catheter, the new stent leverages Medtronic's balloon-tapering and -folding technology to minimize the delivery system's profile.

• Merge Healthcare (Milwaukee, Wisconsin) reported the release of eFilm RIS/PACS, an imaging informatics solution for single imaging centers performing up to 10,000 studies annually. Merge says that eFilm RIS/PACS is a cost-effective way for small imaging centers and specialty practices to acquire basic RIS/PACS functionality. For visualization, eFilm RIS/PACS features eFilm workstation. All that is required is installation of the web server by Merge or onsite resources. The server is shipped with the eFilm RIS/PACS software installed. Start-up is simplified by virtue of a single feature configuration, which provides workflow features, ranging from scheduling to report creation.

• Neoteric Technology (Vancouver, British Columbia) said that a new study released in the Journal of Transfusion of the American Association of Blood Banks demonstrates "dramatic" time and cost savings achieved with BloodTrack OnDemand. The study describes remote allocation, a new way of providing blood to patients. This process allows unallocated (non-crossmatched) blood to be stored in automated "smart" refrigerators in patient care areas such as the operating room. When a blood unit is required, it can be electronically assigned by the refrigerator and labelled for a specific patient without involving the blood bank. Blood bank staff benefit from decreased workload through fewer blood requests, fewer returned units, increased inventory visibility, and increased job satisfaction by distributing the workload throughout the day. Clinical staff benefit from quicker access to blood at the point of care, reduced paperwork, increased confidence in giving the correct blood, and reduced time spent managing the blood delivery process.

• Omron Healthcare (Kyoto, Japan) reported development of the HEM-Solar series, solar-powered digital blood pressure monitors. There will be two blood pressure monitors for the series, a manual upper-arm and automatic upper-arm model. Both are charged by exposure to sunlight through the solar panel at the back of the product. After four hours of direct exposure to sunlight, the manual model can take more than 100 readings while the automatic model can take 28 readings. The products feature AES (-1) plastic material, which is durable against UV light; an important component given the device's frequent exposure to sunlight. The devices also feature embossed buttons on the front panel to protect against exposure to precipitation. Omron aims to release the products in spring 2009. Omron Healthcare makes medical, home healthcare, and wellness products.

• Onset Therapeutics (Cumberland, Rhode Island) reported the launch of Anestafoam, a topical foam formulation containing lidocaine 4%. Anestafoam incorporates the company's Delevo foam technology and is indicated for the temporary relief of pain associated with minor cuts and scrapes, abrasions, skin irritation, sunburn, burns and insect bites. Delevo foam technology incorporates active ingredients in a foam vehicle that uses a semi-solid emollient micro-emulsion system to deliver the active ingredient rapidly and efficiently. The foam is moisturizing, alcohol-free, easy to spread over large areas of the body, and leaves no messy residue after absorption into the skin. Onset specializes in the development of skin treatments.

• Orthovita (Malvern, Pennsylvania) reported the launch of Vitoss bioactive foam as the newest addition to its bone graft substitute product line. The foam contains bioactive glass that induces natural calcium phosphate growth onto the surface of the implant. The foam has the ability to soak and hold its own volume in bone marrow aspirate while retaining these biological fluids in pliable and compression resistant forms. Orthovita is a spine and orthopedic biosurgery company.

• Osteotech (Eatontown, New Jersey) reported FDA 510(k) clearance of its Plexur M biocomposite. Adapting the company's Plexur technology, Plexur M is intended for use in filling bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. During the healing process, Plexur M is remodeled and replaced by host bone. Plexur M is a flexible biomaterial composed of mineralized cortical fibers bound in a resorbable polymer. When heated, this biocomposite becomes moldable and pliable allowing a surgeon numerous options for use during surgery. During the cooling process, Plexur M hardens providing a versatile porous scaffold to assist in regeneration of damaged and diseased bones. Osteotech specializes in the development of technologies for regenerative medicine.

• Paradigm Medical Industries (Salt Lake City) reported introducing advances to its Paradigm-Dicon LD400 full-field autoperimetry system. The LD400 is used to measure patient visual fields to determine the severity of glaucoma and to aid in managing the disease. New developments to the LD400 include redesigning the existing software, assuring device compatibility with a variety of printers and making the device fully networkable. All connections will be through USB ports. Paradigm specializes in the development of ultrasound devices.

• Photo Therapeutics (Carlsbad, California) said it has received FDA approval of its new, over-the-counter, light therapy device, Omnilux New-U, for the treatment of periorbital wrinkles. The company said that Omnilux New-U has been clinically proven to reduce periorbital wrinkles and to treat the visible signs of aging, using a combination of alternate treatments of infrared and red light twice a week for four weeks. Photo Therapeutics was established in 1998 with the right to the patented photodynamic therapy technology, the Paterson Lamp, later launched as Omnilux.

• Power3 Medical Products (Houston) reported publication of the discovery of protein biomarkers for esophageal malignancies in the International Journal of Cancer, in an article titled: "Alterations in Barrett's-related adenocarcinomas: A proteomic approach." Esophageal malignancies are the sixth leading cause of cancer death in the world and represent about 1% of the cancers diagnosed in the U.S. "Power3 discovered differential expression of these protein biomarkers in esophageal biopsies of normal, pre-cancerous, and cancerous areas from the same patients, using our quantitative 2-D gel electrophoresis platform," said Essam Sheta, MD, a study investigators. "Our finding identify a previously unknown potential oncogenic signaling mechanism in Barrett's tumors, and represents a new area that can be developed." Power3 specializes in protein biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets for cancer and neurodegenerative diseases.

• Provista Diagnostics (Phoenix) reported the availability of the Provista Memory Test and the Provista Memory Test PLUS. The two self-administered tests are designed to evaluate the inability to recall common associations that may indicate that further medical assessment and intervention is required. The Provista has been designed to test for cognitive and memory impairment and consists of 20 simple questions to assess memory and thinking ability. It is based on tests similar to those physicians use to routinely measure these abilities in their patients. The test consists of 12 odor strips to identify and is scored in less than five minutes. The Provista Memory Test PLUS was developed based on extensive independent research sponsored in part by the National Institutes on Health and Aging. Provista is a diagnostic development company.

• The Home Respiratory Care Group of Respironics' (Murrysville, Pennsylvania) reported availability of EverFlo Q, a 5-liter stationary oxygen concentrator, the newest member of the company's Freedom Series of oxygen therapy products. The 31 pound EverFlo Q oxygen concentrator is designed to provide ultra-quiet oxygen therapy to patients while reducing provider costs such as maintenance, unscheduled patient calls and visits, and shipping and storage. The EverFlo Q stationary concentrator produces a typical sound level of just 40 decibels. The Sleep and Home Respiratory Group makes products for the management of sleep disorders and chronic respiratory problems.

• Response Genetics (Los Angeles) said that its ResponseDX: Lung and ResponseDX: Colon tests are now available to select medical institutions and practice groups through its CLIA-registered laboratory. ResponseDX: Lung and ResponseDX: Colon are PCR-based tests that help guide therapeutic treatment decisions in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). This test measures ERCC1 gene expression, a molecular marker to identify NSCLC and CRC patients who may and may not benefit from platinum-based therapy. Response is engaged in the R&D of pharmacogenomic cancer diagnostic tests.

• Rubbermaid Medical Solutions (RMS; Huntersville, North Carolina) reported the launch of a new M38 Mobile computer cart line featuring a powered computer cart, pre-wired computer cart and non-powered computer cart. The new line adds to the overall RMS product offering, which also includes medication carts, wall mounted work stations, and transfer and exchange carts. Key features for the M38 cart include compact 17" x 17" base contoured to 14.5" wide at the center; fully adjustable keyboard tray including 6" of height range, 180 swivel and -15 to +10 tilt; work surface has a 16" range of adjustable height with a total keyboard range of 22"; and multiple storage options including side bins, a wire basket and a drawer with keyless entry. Rubbermaid Medical makes mobile carts and mobile computing solutions for healthcare facilities.

• Siemens Healthcare (Malvern, Pennsylvania) has received FDA clearance for two solutions for urological applications: Lithoskop and Modularis Variostar. Encompassing lithotripsy, endourology, urodiagnostics, and percutaneous interventions, Lithoskop is a multifunctional, high-end system for many urological applications. Its flexible shockwave head makes patient repositioning a thing of the past. The system offers stone localization with X-ray, as well as inline X-ray and inline ultrasound imaging. Lithoskop's high-performance X-ray generator and powerful image intensifier with 1 K2 matrix delivers reliable image quality for optimal diagnosis and therapy. Modularis Variostar provides a urology platform that consists of components that can be used separately or in combination. It is suited for traditional urodiagnostics, extra- and intracorporeal shockwave therapy, and endourological interventions, according to the company.

• Smiths Medical (St. Paul, Minnesota), part of the Smiths Group, reported FDA 510(k) clearance for its CADD-Solis Ambulatory Infusion System, describ ing it asa next-generation ambulatory infusion platform. The CADD-Solis Ambulatory Infusion System includes: CADD-Solis Ambulatory Infusion Pump, CADD-Solis Medication Safety Software, and CADD Medication Cassette Reservoirs and Administration Sets. The pump features a large color graphic display screen, task-based software and cell-phone design. The safety software allows hospitals to create their own standardized pain management protocols, downloaded directly into each CADD-Solis pump so a clinician can select the specific pain management protocol for each patient's individual therapeutic needs.

• Sonic Innovations (Salt Lake City) has added hands-free automatic features to ion, its smallest hearing aid product line. The ion 400 is a micro behind-the-ear product (micro-BTE) with 24-channel digital signal processing, eight channels more than the ion 200. The ion 400 is an open-ear model, for those with mild to moderately severe hearing loss, equipped with voice alerts, a feature that replaces beep sequences. The voice alerts talk to the user, informing him or her when the hearing aid is changing programs (for example, when shifting to telephone mode) and when the battery is low. .

• SonoSite (Bothell, Washington) reported the introduction of the new M-OB/GYN Office ultrasound tool for the physician's office. Based on SonoSite's fourth generation M-Turbo platform, the M-OB/GYN Office system delivers an exponential increase in processing power and superior image clarity for obstetrical and gynecological imaging, plus connectivity for digital image export in a rugged, easy to use form factor. Each M-OB/GYN office tool comes complete with two transducers — the C60x/5-2 MHz curved array transducer for abdominal scanning and the ICTx/8-5 MHz intracavitary curved array transducer for pelvic imaging. A specialized software package includes Tissue Harmonic Imaging, color Doppler and advanced OB calculations. SonoSite also introduced the S-MSK ultrasound tool, which it said is the first ultrasound product customized for musculoskeletal specialists — including rheumatologists, physiatrists, sports physicians, orthopedic and osteopathic surgeons and physical therapists. Configured for use with SonoSite's HFL38x and L25x broadband transducers, the S-MSK provides imaging of superficial and deep targets for a quick-look assessment and guidance of interventional procedures such as injections and aspirations of the knee, shoulder, elbow and other joints in the body.

• Spinal Kinetics (Sunnyvale, California) said that it has enrolled the first U.S. Feasibility Study patient and implanted the company's M6-C artificial cervical disc. In December of 2007 the company reported receivng FDA approval from to initiate a study evaluating the M6-C artificial cervical disc with patients suffering from degenerative disc disease of the cervical spine; a common cause of neck and arm pain. The M6 artificial disc represents the company's first non-fusion, motion preservation products to treat degenerative diseases of the spine. Spinal Kinetics says that the M6's compressible polymer nucleus is designed to simulate the function of the native nucleus, while the surrounding multi-layer high tensile strength fiber annulus is intended to facilitate a controlled range of motion in multiple directions. The M6 artificial disc is implanted with the company's proprietary surgical instrumentation.

• Staar Surgical (Monrovia, California) said that the Afinity Collamer aspheric foldable intraocular lens (IOL) model CQ2015A has been designated as a new technology intraocular lens (NTIOL) by the Centers for Medicare and Medicaid Services (CMS). To receive NTIOL recognition an IOL must first be an FDA approved IOL with labeling and advertising consistent with the specific claim or characteristic for which CMS approval is being sought. The Collamer is a lens material that is composed of collagen, a UV-absorbing chromophore, and a poly-HEMA based copolymer. The three piece collamer IOL combines foldable IOL technology with traditional design. This cataract IOL has modified "C" loop polyimide haptics with five degrees of angulation. These loops offer flexibility comparable to polypropylene and PMMA haptics, with greater tensile strength, and superior "shape memory." The lens edge of model CQ2015A has a square posterior edge and rounded anterior edge. STAAR Surgical makes minimally invasive ophthalmic products.

• Synbiotics (Kansas City, Missouri) said that it is seeking 510(k) authorization from the FDA for the use of its FluDetect Avian Influenza Virus rapid test strip in humans. Currently, the FluDetect product is the only USDA approved rapid point of care test for avian influenza in the veterinary field. FluDetect has been heralded for its sensitivity in a simple to use test format that requires no equipment, nor extensive training to perform. Synbiotics makes veterinary diagnostic products.

• SynergEyes (San Diego) has launched a hybrid contact lens designed for those who need further vision correction after undergoing refractive vision surgery. SynergEyes PS (post-surgical) is also designed for people who have experienced some type of corneal trauma or suffer from certain degenerative vision conditions. The contact lenses combine two materials — a rigid gas permeable center with a soft lens outer skirt. The hybrid design bonds a hard and soft contact lens together, resulting in a vision correction option the company said provides "crisp, clear vision for surgically altered corneas in a comfortable, healthy contact lens."

• Technology4Medicine (San Clemente, California) and A.R.C. Laser (N rnberg, Germany), a producer of high quality medical lasers, said the FDA has granted clearances for the FOX diode dental lasers. Technology4Medicine, in partnership with A.R.C., is offering the FOX lasers in the broadest range of wavelengths available including 810nm, 980nm or 1064nm to meet the specific clinical needs of the U.S. dental and hygiene community. Technology4Medicine, and its dental laser division, Lasers4Dentistry, makes lasers and other advanced high technology products for the dental, medical, veterinary and physiotherapy markets.

• Third Wave Technologies (Madison, Wisconsin) said it has received FDA clearance of its InPlex CF molecular test. The test simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. The InPlex delivers the accuracy of Third Wave's Invader chemistry in a microfluidic card developed in collaboration with 3M. The InPlex is a genotyping test that provides information for cystic fibrosis carrier screening for adults of reproductive age as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children. Third Wave makes diagnostic reagents for a variety of DNA and RNA analysis applications.

• Verathon (Bothell, Washington) reported a new small child mode for the portable BladderScan BVI 9400 bladder volume instrument with NeuralHarmonics technology. Small Child Mode enables health care providers to measure bladder volume noninvasively on children weighing less than 60 pounds and standing less than 48 inches high with the same instrument used for adult patients. When the scan button is pressed, the instrument measures ultrasonic reflections on multiple planes inside the body and produces a three dimensional image. Based on this image, the BVI 9400 calculates and displays the bladder volume on the color console, and offers aiming assistance (if needed) to the user, on both the probe and the console. The user can select either a hard copy print out from the machine or an electronic medical record (EMR) related report.

• Vermillion (Fremont, California) presented data from several studies demonstrating the benefits of the company's ovarian cancer protein biomarker panel. The data suggest that use of Vermillion's biomarkers could help better identify women with ovarian cancer, as well as improve the detection of early-stage disease. A clinical study examining Vermillion's marker panel for ovarian cancer provided independent validation that it can distinguish malignant tumors from benign pelvic masses. Results of the study demonstrated that the biomarker panel could more than double the number of ovarian cancer cases referred to a gynecologic oncologist, thereby improving survival rates and reducing the number of surgeries performed. Vermillion is a molecular diagnostics company.

• VertiFlex (San Clemente, California) said that it has received FDA clearance for the Silverbolt Percutaneous Multi-Level Rod (MLR) system. The Silverbolt is designed to percutaneously deliver two rods into a single screw for multi-level spine stabilization applications. Using the Silverbolt MIS delivery system, the MLR stabilizes multiple vertebral levels of the spine percutaneously, thereby offering patients an alternative to traditional, more invasive approaches. The MLR delivers two independently acting rods into one central polyaxial screw. The first rod is reduced down into one of two adjacent polyaxial heads and secured. The second rod is then reduced down the same screw into the remaining adjacent polyaxial head and secured. Each screw is therefore capable of accepting two rods, which allows for multiple levels of fusion. VertiFlex makes minimally invasive and motion preservation technologies for spine disorders..

• WaferGen Biosystems (Fremont, California) reported launch of the SmartSlide 200 Micro-Incubation System, building upon its SmartSlide product line by offering programmable perfusion of multiple nutrients and gases (oxygen, carbon dioxide and nitrogen) for the first time. It said that the ability to precisely control and vary these parameters helps researchers mimic physiological growth conditions, allowing them to create anoxia and hypoxia conditions needed for the growth and differentiation of stem cells. WaferGen makes gene expression, genotyping, cell biology and stem cell systems for research application.