BB&T

An advanced generation of a type of mechanical support for heart failure patients, receiving FDA approval, may signal the wave of the future for heart technology, according to its manufacturer. Not only has it opened the therapeutic door for the sickest women and smaller men, and offers a new paradigm for this type of device. With news in late April that the HeartMate II Left Ventricular Assist System (LVAS) from Thoratec (Pleasanton, California) was FDA-approved, several milestones were achieved.

The HeartMate II is an axial flow device that can pump up to 10 liters of blood per minute, the full output of a healthy heart. It is implanted as an attachment to the patient's native heart and takes over the pumping ability of the weakened heart's left ventricle.

"This is the very first of its kind LVAS and is very significant — it's where this type of mechanical heart technology is going now, FDA spokeswoman Karen Riley told Biomedical Business & Technology.

Previous pumps were pulsatile, meaning that they had a beating action and simulated the beating of the heart. HeartMate II uses a continuous flow pump that constantly produces blood flow with a single moving part, a spinning rotor.

This allows the device to be smaller, and because there's only one moving part, the potential for breakage is greatly reduced, Riley pointed out.

Thoratec is riding the wave, saying that it will work quickly to roll out the HeartMate II for that indication while continuing the same study, seeking approval for a second, even broader population.

The approval is specifically intended to be used as a temporary fix for patients awaiting transplantation, the indication thus being Bridge-to-Transplantation (BTT). The target pool of patients is those with New York Heart Association Class IV heart failure.

The HeartMate II has been downsized amd sp can be implanted in women and smaller men. It also is more durable, able to last up to 10 years, according to Thoratec.

"Typical patients who come to mind are those who need some sort of support as a BTT, Thoratec's David Smith, executive VP and CFO, told BB&T. "Not just women, but men who are smaller. In the past, certainly smaller body sizes have been under-served. Predecessor devices have been too large. We're pleased the label allows the physician to make the determination on which device and size to use.

Now, Thoratec forges ahead with part two of its REMATCH clinical study of the device, for patients who were not candidates for cardiac transplantation but meeting specific inclusion and exclusion criteria. It's the first time the FDA has approved a clinical trial with both indications in one protocol.

Dubbed the Destination Therapy (DT) study, the criteria of this second-part, 479-patient trial includes patients who are not yet as ill as those in the original REMATCH trial, and it allows for inclusion of some late New York Heart Association Class IIIB heart failure patients.

"Destination therapy would be for those patients who are not transplant-eligible, Smith said. "This is a larger patient population. One of our devices is currently approved for this indication [Heartmate XVE]. But it hasn't seen much uptake because of durability of the device, which is 18 to 24 months. We believe HeartMate II has much greater durability ... out to 10 years.

Between 2,000 and 2,500 Americans receive a heart transplant each year, while another 25,000 to 50,000 die waiting for a donor heart to become available. Upwards of 5 million Americans suffer from heart failure.

With a price tag of $80,000, Smith said HeartMate II is covered for virtually all payers, public or private. For Medicare, implantation of VADs has been covered since the late-1990s under a National Coverage Determination for VADs used as BTT.

"CMS over last couple of years has recognized the value of mechanical support and ventricular devices in particular, he said. "Last October, the DRGs that would be associated went up 25%. So that was a strong endorsement for these types of devices.

Elsewhere in the product pipeline:

• Abbott (Abbott Park, Illinois) has introduced the Architect i1000SR immunochemistry analyzer. The analyzer is designed for labs that typically perform fewer than 200 immunoassay tests per day. The i1000SR analyzer can process up to 100 tests per hour. The instrument accommodates 65 patient samples and has the capability to prioritize emergency test results and turn them around in less than 16 minutes. Abbott recently introduced three other instruments in the Architect family: the c16000 clinical chemistry analyzer, the ci16200, an integrated immunoassay and clinical chemistry analyzer, and the i4000SR analyzer for high volume immunoassay testing. Abbott Diagnostics makes in vitro diagnostics products, offering a range of instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.

• Ablation Frontiers (Carlsbad, California) said that data on the first five patients enrolled in a study involving its radio frequency (RF) ablation catheter and generator were presented by Stefania Riva, MD, at the 7th annual session of the Italian Association of Arrhythmology and Cardiac Pacing on April 3 in Milan. The patients, two of whom presented with permanent atrial fibrillation and three with paroxysmal atrial fibrillation (AF), underwent pulmonary vein isolation without any reported complications. The procedures were conducted using the PVAC pulmonary vein ablation catheter and multi-channel GENius generator for ablation catheters. The PVAC was used for both mapping and ablating during the procedures. "The use of a single mapping and ablation catheter has streamlined and simplified the procedure, said Riva. Ablation Frontiers makes anatomical-based catheters and a multi-channel RF generator.

• Two independent studies published in American Journal of Rhinology and Annals of Otology, Rhinology & Laryngology confirm that balloon sinuplasty technology safely opens narrow sinuses, is economical, and highly satisfactory to chronic sinusitis patients. The peer-reviewed studies analyzed outcomes of more than 1,100 individuals treated with this minimally invasive balloon technology from Acclarent (Menlo Park, California). Balloon sinuplasty technology is similar in concept to catheters used in the heart for balloon angioplasty. The devices are threaded into the sinus passageways and gently inflated, widening the passages to promote drainage and resolution of chronic sinusitis symptoms. The technology can be used alone or with standard surgical instrumentation. Recovery times vary, but patients typically return to normal activities within 24 hours of treatment. Acclarent makes technologies for ear, nose and throat surgeons.

• Accuray (Sunnyvale, California) said that a study published in the International Journal of Radiation Oncology/Biology/Physics showed that the CyberKnife robotic radiosurgery system can serve as a non-invasive means for delivering high dose rate (HDR) brachytherapy. It said that the study supports the CyberKnife's flexibility in treating prostate cancer and expands the non-invasive options available to clinicians and patients. HDR brachytherapy has been shown to be an extremely effective approach for treating prostate cancer, with substantial clinical evidence supporting its usage. Nevertheless, the required insertion of multiple catheters into the prostate, where they remain for the duration of the procedure (typically one to three days), makes it an invasive procedure. The CyberKnife system is a robotic radiosurgery system designed to treat tumors anywhere in the body using continual image guidance technology and computer controlled robotic mobility. Accuray says that CyberKnife tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment to deliver high-dose radiation with precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames.

• Affymetrix (Santa Clara, California) said that Pathwork Diagnostics (Sunnyvale, California) will begin offering a molecular diagnostic test based on the Affymetrix microarray platform. Pathwork's tissue-of-origin test is one of the first microarray-based diagnostic tests for cancer in the U.S. The test is being made available through the CLIA-certified Pathwork diagnostics laboratory. The Pathwork tissue of origin test is designed to help oncologists determine the primary site of a metastatic tumor with greater certainty. The company partners with diagnostic companies through its Powered by Affymetrix (PbA) program.

• Allegro Diagnostics (Boston) reported a publication of a "clinico-genomic model for lung cancer diagnosis in the inaugural edition of Cancer Prevention Research, a new journal from the American Association for Cancer Research. "One of the important findings from this study is that the clinico-genomic model using Allegro's genetic biomarker performed best in those patients who were considered most difficult to diagnose by a physician panel, said Dan Rippy, president/CEO of Allegro. "Also, given the fairly low detection rate of bronchoscopy for stage I lung cancer at 15[%] to 20%, a clinico-genomic model using our gene expression biomarker has the potential to dramatically increase the rate of detection for early-stage disease ... . Allegro develops molecular diagnostics for lung cancer and other epithelial diseases using proprietary gene expression technology.

• Angiotech Pharmaceuticals (Vancouver, British Columbia), received 510(k) clearance from the FDA for its 5-Fluorouracil-coated (5-FU) Central Venous Catheter (CVC). The catheter is the first drug-eluting medical device product to be researched and developed completely in-house by Angiotech's R & D and clinical teams, without the aid of a corporate partner. The company said 5-FU, which it termed "a well-known and FDA-approved drug," has "effectively demonstrated" its ability to prevent catheter-related infections as compared with CH-SS-coated catheters. Angiotech said that, since 5-FU is not routinely used as either a systemic antibiotic or a hospital antiseptic, "There may be a reduced risk to the hospital or the community at large of creating a 'Super Bug' that is resistant to useful classes of antibiotics and antiseptics and may make infection control more complex."

• Archus Orthopedics (Redmond, Washington) reported completing the first human implant of its TFAS-C system, an addition to its product line for treating spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs. Traditionally, patients with moderate-to-severe spinal stenosis undergo decompressive laminectomy surgery, often accompanied by spinal fusion. Archus says that its products replace degenerative facet joints with a prosthetic joint implant intended to restore stability and normal motion to the spine, eliminating the need for fusion. The TFAS-C is indicated for the L3-4 and L4-5 spinal levels and complements the company's TFAS-LS system, which addresses the anatomy of the L5-S1, "lumbosacral spinal level. Archus makes reconstructive implants.

• ArthroCare (Austin, Texas) said that it has expanded its Parallax line with Parallax Contour, a poroduct designed to mechanically displace soft bone in fractured vertebrae. The product set includes a variety of products used for the minimally invasive stabilization of vertebral compression fractures (VCFs). Parallax Contour integrates with the company's line of Threaded Cannulae, the Parallax Contour, an osteotome, uses a movable, curved stylet to displace soft bone. This displacement of soft bone improves access into the vertebral body, which can then be filled with the injection of bone cement. The Contour uses a small access needle and is precisely advanced and rotated to prepare the space within the vertebral body. Conventional systems for enhanced vertebroplasty include high pressure injection systems such as balloon kyphoplasty. Arthrocare makes minimally invasive surgical products.

• ATS Medical (Minneapolis) reported the first North American commercial implant of its 3f Aortic Bioprosthesis. ATS says the bioprosthesis uses design concepts intended to preserve native aortic root geometry and function. Through this approach, the prosthesis more closely mimics native valve function providing excellent hemodynamic performance that may contribute to improvements in key determinants of cardiovascular performance such as coronary blood flow and left ventricular mass regression. ATS specializes in making cardiac surgery products and providing associated services.

• Bluestar Silicones (East Brunswick, New Jersey) has introduced a range of Silbione brand soft liquid silicone rubber (LSR) products for healthcare that it says provide a combination of strong physical properties and trouble-free processing at 05-, 10- and 25-ShoreA durometers. These products use Bluestar Silicones' Silbione 30- to 70- ShA LSR product line for applications such as orthopedic insoles and liners, baby products and molded medical devices. Established through the acquisition of Rhodia Silicones by China National BlueStar, Bluestar is a supplier of silicones with manufacturing operations in all regions of the world.

• Brahms USA (Annapolis, Maryland) said it has received FDA clearance for its Procalcitonin (PCT) Kryptor test to be used in critically ill patients on the first day of admission to the intensive care unit as an aid to assess risk for progression to severe sepsis and septic shock. The test will assist in determining whether an infection is bacterial or viral and provide information on the severity of a patient's condition less than an hour after a blood sample is drawn. Bacterial infections cause PCT to be produced by almost every organ of the body, resulting in a rapid rise of PCT levels in the blood and a reflection of the severity of bacterial infection. Brahms makes blood tests for clinical use.

• Boston Scientific (Natick, Massachusetts) reported completion of enrollment in the Multi-center Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). The trial includes 1,820 patients and examines the potential benefits of the company's cardiac resynchronization therapy defibrillators (CRT-Ds) in a new population of heart failure patients. Following the MADIT, MADIT II and COMPANION trials, MADIT-CRT is sponsored by Boston Scientific's cardiac rhythm management group. The company said the trial is designed to test whether CRT-Ds can slow the progression of heart failure in heart attack survivors and in those with other forms of impaired heart function. It said that the trial may demonstrate if earlier CRT-D therapy can slow a patient's progression from early-stage New York Heart Association Class I and II heart failure to Class III and IV. "This study builds on the observations made in the COMPANION trial, which evaluated the benefits of CRT-D therapy in patients with late-stage, symptomatic heart failure, said Arthur Moss, MD, principal investigator of MADIT-CRT. It could address, he said, the still-unanswered question about the potential of resynchronization defibrillator therapy to inhibit the clinical progression of heart failure through earlier intervention. About 70% of all heart failure patients fall into Class I or II. Nearly 22 million people worldwide, including about 5.5 million Americans, suffer from some form of heart failure.

• BSD Medical (Salt Lake City) said that the company has filed its 510(k) premarket notification submission to the FDA for its MicroThermX-100 microwave ablation system. The MicroThermX-100 is designed as a stand-alone therapy that is used to ablate diseased tissue using heat alone. BSD makes precision-guided radio frequency and microwave systems used to treat cancer at mild temperatures using hyperthermia to kill cancer cells and boost the effectiveness of companion treatments with radiation.

• Canon U.S.A. (New York) has introduced the Canon CR-1 Non-Mydriatic Digital Retinal Camera providing what it describes as "high-resolution diagnostic images of the retina, and enabling a 45 view angle to aid in the detection and monitoring of ocular conditions.

• CMS (St. Louis) has completed internal and external validation testing for its Atlas-Based Autosegmentation solution. The Autosegmentation is a stand-alone software application that produces estimates of anatomy boundary contours needed to create a radiotherapy treatment plan. This program communicates with radiotherapy planning programs via DICOM-format data. An atlas is simply an existing CT image with anatomy contours. Atlas-Based Autosegmentation uses deformable registration to match the atlas image to corresponding points in a novel patient image. The atlas contours are then mapped onto the patient using that deformation. Users can create new atlases or modify existing atlases to contour patients spanning ranges of conformations and diagnoses. CMS makes radiation treatment planning and workflow management solutions.

• Connect Imaging (Honolulu, Hawaii) has introduced new software for use with FCRm digital mammography systems from FUJIFILM Medical Systems USA. According to Philip Manly, CEO of Connect, the company developed its newest module, called VCM Port, to address an issue Connect Imaging identified while validating its picture archiving and communication syste (PACS) for use with Fuji's computed radiography mammography system installed at one of Connect's clients. Manly said that Fuji has fully validated the VCM Port software and now offers it for use with the company's FCRm digital mammography systems. Users of Fuji's FCRm system also may purchase the software directly from Connect. Connect speciaolizes in PACS development.

• CoolTouch (Roseville, California) reported the introduction of its CoolBlue Duet laser lipolysis suction handpiece set designed to be used with the CoolLipo 1320 laser system. Using a standard liposuction cannula, ablation with aspiration and skin tightening are accomplished all in one action. The CoolLipo procedure is performed in a physician's office under local anesthesia. CoolTouch manufactures medical lasers.

• Corgenix Medical (Denver, Colorado) reported FDA clearance for the its IgG Anti-AtherOx test kit, a laboratory test that uses the company's AtherOx technology to detect antibodies in individuals with "important autoimmune diseases. AtherOx technology uses oxidized low-density-lipoprotein (oxLDL) complexed with the plasma protein B2GPI. Although oxLDL has been implicated in cardiovascular disease, determination of oxLDL/B2GPI complexes, rather than oxLDL alone, may be a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease in individuals with systemic lupus erythematosus and lupus-like disorders, according to the company. The IgG test kit indication is used for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with B2-glycoprotein I (B2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). Corgenix makes diagnostic kits for vascular diseases, immunology disorders, and bone and joint disorders.

• Delcath Systems (New York) said that the institutional review board of the University of Maryland Medical Center (UMMC; Baltimore) has approved UMMC's participation in the Phase III study of the company's percutaneous hepatic perfusion (PHP) system for the isolated, high-dose delivery of the anti-cancer agent melphalan to treat inoperable metastatic melanoma in the liver. The study is being led by the National Cancer Institute, which previously approved the study's expansion to a multi-center trial. The study is designed to test Delcath's PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The Delcath system is designed to deliver significantly higher doses of anti-cancer drugs to a patient's liver while preventing entry of the drugs to the rest of the patient's circulatory system. This isolation limits toxicities that result from systemic chemotherapy treatments. Delcath makes percutaneous perfusion technology for the isolated delivery of therapeutic and chemotherapeutic agents.

• DePuy Spine (Raynham, Massachusetts) has launched the Viper2 Pedicle Screw Fixation System, a minimally invasive spine system offering what the company termed "comprehensive instrumentation and implant options that can be used on a wide range of spinal pathologies including deformity, trauma, tumor and degenerative disc disease. DePuy Spine made the announcement at the 76^th annual meeting of the American Association of Neurological Surgeons (Rolling Meadows, Illinois) in Chicago, where it is showcasing the Viper2 System. DePuy Spine said Viper2 is the first minimally invasive rod-and-pedicle screw system that can be used to perform minimally invasive spinal fixation across the length of the entire thoracolumbar spine (T1 to pelvis), with rods of any curvature and lengths from 30 mm to 480 mm. The company says that the new rod insertion technique allows surgeons to utilize existing incisions to deliver any curvature rod up to 480 mm long, eliminating the need for remote rod insertion and complicated alignment jigs. The 5.5 mm-diameter titanium rods come in straight, pre-lordosed and pre-kyphosed configurations or can be contoured on-site to match the patient's anatomy. DePuy also reported the launch of the Vertigraft VG1 cervical allograft, a bio-implant for anterior cervical fusion surgery designed to align with the spinal anatomy. The allograft is made of a single piece of cortical bone that is freeze-dried for room-temperature storage. Its trapezoidal design matches the anatomy of the cervical spine, stabilizing the implant by increasing the surface area. Its open central chamber allows surgeons to add graft material of their choice. The cervical bio-implant features a bulleted posterior edge to facilitate graft insertion and a textured surface for resistance to migration. Its seven-degree lordotic angle maintains proper alignment of the spine.

DePuy Spine also reported the launch of the Concorde bullet vertebral body replacement, a new implant with a bulleted nose that facilitates easy insertion and pyramidal teeth that resist anterior migration during posterior and minimally invasive spinal fusion procedures. The Concorde bullet minimizes insertion forces, which can reduce the risk of damage to vertebral bodies. It is inserted between collapsed vertebral bodies and restores height. Once inserted, its pyramid-shaped teeth provide resistance to anterior migration. The lordotic option is designed to create 5 of lordosis when placed obliquely (diagonally) across the midline. DePuy Spine specializes in technologies for treatment of spine disorders.

• Dolbey (Concord, Ohio) has introduced a new speech-recognition product, Voice2Text, designed for the medical transcription service industry and offers the productivity enhancements of back-end speech without requiring a change to the document management platform used by the service company. With Voice2Text, speech recognition has been integrated with Dolbey's fusion voice digital dictation system and provides simple integration to a company's existing document platform. This approach to applying back-end speech is being offered in a pay-as-you-go model to minimize up-front investment. Dolbey specializes in healthcare dictation, transcription, speech and coding products.

• Entropy Solutions (Minneapolis) introduced the Greenbox thermal management system, a temperature-controlled shipper designed to keep contents at a consistent temperature for more than five days. The Greenbox system is constructed of a durable plastic outer shell; Thermal-Lok insulation panels, which protect temperature-sensitive goods from external weather conditions; and E-Packs, which contain a combination of patented phase change materials. In a typical Greenbox, two sets of two different phase change materials simultaneously absorb and release heat — while one E-Pack liquefies, the other solidifies providing a "thermostat effect. This happens continuously until the package reaches its destination. Entropy Solutions is a tdeveloper of ghermal technology.

• HeartWare (Sydney, Australia) reported initial results from an international clinical trial of the HeartWare Left Ventricular Assist System. The data show a six-month survival rate of 91% among the first 23 patients implanted with the HeartWare device. The study noted that one of the key features of the pump is its small size, which allows it to be implanted in the chest, thereby avoiding the abdominal surgery generally required to implant competing devices. HeartWare makes implantable heart pumps.

• Henkel (Rocky Hill, Connecticut) has made a multifunctional base coating, Alodine EC2 ElectroCeramic Coating, designed to provide chemical, corrosion, temperature and abrasion resistance. This temperature resistant coating creates a non-conductive surface on surgical instruments and can extend the life of titanium utensils, screws, and replacement ball and socket joints. Based on titanium electro-deposited oxides, Alodine EC2 coats aluminum, aluminum alloys, titanium, and titanium alloys, as well as aluminized, aluminum-plated and IVD aluminum substrate. The coating also is suitable for aluminized ferrous materials. This base coating can improve the corrosion resistance and performance of marine engines, automotive powertrain and components, appliances, cookware and other industrial parts exposed to moisture, fuel, oil and other environmental contaminants. Henkel operates in the home care, personal care and adhesives technology sectors.

• HepaLife Technologies (Boston) said it will present new data from ongoing R&D of its artificial liver device technology at the 6th annual meeting of the International Society for Stem Cell Research (Rolling Meadows, Illinois) in June. In tests designed to represent the environment present when treating human liver failure patients, HepaLife's PICM-19 liver cells were exposed to human blood plasma and toxic ammonia. The PICM-19 cell line removed toxic ammonia, produced urea, and expressed CYP-450 enzymes. Intended for the treatment of liver failure, the HepaLife Bioartificial Liver device consists of three basic components: a plasma filter, separating the patient's blood into blood plasma and blood cells; the bioreactor, a unit filled with the PICM-19 liver stem cell line which biologically mimics the liver's function; and the HepaDrive, a perfusion system for pumping the patient's plasma through the bioreactor while controlling gas supply and temperature for best possible performance of the cells. HepaLife makes cell-based medical technologies.

• Hill-Rom (Batesville, Indiana) reported the release of an enhanced NaviCare WatchChild solution, an obstetrical information system designed to create information movement for labor and delivery clinicians. The company said the redesigned WatchChild evolved from a need to provide an integrated and intuitive way to manage obstetrical operations, including reporting, communication, care plan development, skin and fall assessment screening and operating room record/pre-anesthesia checklists. The NaviCare WatchChild also offers data archiving capability to help manage long-and-short-term liability risks for hospitals and caregivers, and the system is part of the NaviCare Clinical Operations Platform. Hill-Rom makes patient support systems, non-invasive therapeutic products for acute and chronic medical conditions, medical equipment rentals, and information technology solutions.

• iCAD (Nashua, New Hampshire) said that its SecondLook digital computer-aided detection system for mammography received FDA approval for sale with Computed Radiography for Mammography (FCRm) systems from Fujifilm (Stamford, Connecticut). "iCAD's SecondLook Digital system coupled with the Fuji CR Mammography system will improve our ability to detect potentially malignant calcifications and masses and we expect that it will increase our overall standard of care, said Jeffrey Mendel, MD, chairman of radiology at Caritas St. Elizabeth's Medical Center (Boston, Massachusetts). "Additionally, seamless integration of iCAD's product with our PACS system will improve the efficiency of our reading and our overall digital workflow. iCAD makes computer-aided detection solutions for identifying pathologies and pinpointing cancer earlier.

• Identity Sciences (Alpharetta, Georgia), with its science partner the Idaho National Laboratory (INL), has developed a new forensic human identification test, AbP ID, which delivers accurate, reliable results in two hours. AbP ID does not use DNA; instead, it reads special antibodies, Individual Specific Auto-antibodies, found in all human body tissues and fluids. Each individual, including twins, has an antibody profile that is totally unique. The AbP ID test can determine whether the antibody profile of the evidence found at a crime scene matches the profile of a suspect. It works on blood serum and dried blood, providing results in two hours.

• Illumina (San Diego) has launched the iScan system, a scanner that provides researchers conducting genotyping and gene expression studies with more throughput and enhanced automation. The iScan is a high-resolution scanner that supports imaging of Illumina's BeadChip-based genetic analysis products. Using sub-micron resolution, assay automation, and laboratory information management systems options, researchers can produce up to 225 million genotypes per day. Illumina also introduced the HumanHT-12 BeadChip, a 12-sample product designed to accelerate whole genome expression and expression-based Quantitative Trait Loci (eQTL) studies. "The HumanHT-12 BeadChip will enable high-throughput, whole-genome expression and eQTL analysis at exceptional price points. Along with the HumanWG-6, which offers the industry's highest-quality whole-genome expression data, the HumanHT-12 will provide gene-expression researchers with the most flexible and cost-effective screening tool, the company said. Illumina makes products for the analysis of genetic variation and biological function.

• Immunicon (Huntingdon Valley, Pennsylvania) reported the availability of a new product portfolio for Fluorescence In-Situ Hybridization (FISH) testing. The RF Poseidon FISH Probes are available to the life science and diagnostic clinical laboratories. FISH probes are used to detect gene amplification, gene rearrangements, microdeletions, chromosome duplications and other genetic abnormalities. The company said that FISH is used in an increasing number of molecular diagnostic areas, including disease diagnosis, therapeutic targeting, drug development, gene mapping and karyotyping analysis. FISH specifically is used to detect gene amplification, gene rearrangements, microdeletions, chromosome duplications and viral infections. Immunicon makes cell- and molecular-based diagnostic and life science research products.

• Inovio Biomedical (San Diego) reported the publication of data from preclinical studies performed in collaboration with scientists at Beth Israel Deaconess Medical Center (BIDMC; Boston), demonstrating a 77-fold increase in dendritic cells at the site of administration of a DNA vaccine delivered with electroporation compared to a similar amount of DNA delivered using a DNA injection alone. This result suggests that electroporation provides a strong adjuvant effect capable of priming the immune system, partially explaining the apparent enhancement that electroporation has provided in enhancing the potency of DNA vaccines in humans, The company said. Inovio is focused on developing multiple DNA-based immunotherapies and DNA vaccines.

• Madico (Woburn, Massachusetts) reported the introduction of a suite of antimicrobial laminates designed to resist bacterial growth in medical facilities. The Madico AMO-branded films help reduce the risk of secondary — or nosocomial — infections to patients in healthcare settings. The suite consists of three antimicrobial laminates, AMO-TS, AMO-MS and AMO-400. Developed for touch screen manufacturers, the AMO-TS material destroys harmful surface bacteria while safeguarding the screen against abrasion. AMO-MS improves the adhesion of common manufacturing inks used in the printed circuits while incorporating an antimicrobial top coating. Madico makes films for safety and security, energy conservation, renewable energy, and hygienic applications.

• Maquet Cardiovascular (San Jose, California) reported the launch of the Heartstring III proximal seal system for coronary artery bypass surgery procedures. This latest version of Maquet's proximal seal technology helps surgeons perform coronary artery bypass grafts without the use of a partial occlusion clamp during beating-heart surgery. The Heartstring III features an improved seal loader and delivery device, the company said. Once deployed, it maintains a low compliant profile for optimal hemostasis at the anastomotic site. With this device, surgeons have the option to perform distal or proximal grafts first and to use grafts of varying lengths, hooded grafts and angled take-offs. Maquent Cardiovascular, a division of Maquent Medical Systems, makes solutions for less-invasive endoscopic vessel harvesting, off- and on-pump coronary artery bypass surgery, and vascular grafts.

• Medacta USA (Camarillo, California) said that the first muscle-sparing AMIS total hip replacement procedures in the U.S. were performed at North Austin Medical Center (Austin, Texas). Rather than traditional hip replacement techniques in whic the surgeon cuts or dissects the muscles in order to replace the patient's hip joint, AMIS is a minimally-invasive total hip replacement surgical procedure in which no muscles are cut, thus helping to reduce the recovery time for patients so they can resume activities sooner. Medacta makes total joint replacement systems and surgical techniques.

• MediNotes (West Des Moines, Iowa) reported the latest release of its Net-based integrated electronic medical record (EHR)/practice management (PM) solution MediNotes Clinician Spring R2. "This release is the latest example of our unswerving commitment to invest in our single database EHR/PM solution and to provide enhancements requested by physician users to improve their business processes and financial performance, said Donald Schoen, pres-ident/CEO. MediNotes is an EHR developer.

• Medtronic (Minneapolis) reported the U.S. launch of its Activa DBS (deep brain stimulation) patient referral advisor software, designed to help neurologists identify patients with Parkinson's disease who could potentially benefit from a referral to a DBS center or implanter for evaluation for DBS therapy. Activa DBS is used to assist physicians in identifying those patients most appropriate for a referral to a DBS center or implanter for evaluation for DBS. The software was designed with the input of nine expert neurologists who rated more than 900 hypothetical patient profiles, assigning each profile an appropriateness rating for DBS referral. The software is programmed to generate an appropriateness score for any given patient based upon this database of expert opinion.

• Merge Healthcare (Milwaukee) reported the release of eFilm Scan 2.0, an application designed to scan conventional medical films using third-party digitizers. The difference in this new version is its ability to work without the need for an eFilm Workstation desktop DICOM viewer. eFilm Scan supports all major film digitizers and also provides TWAIN support for compliant flatbed scanners. Films may be scanned at various resolutions as 8-, 12-, or 16-bit grayscale images (depending on the digitizer), which can then be windowed/leveled, flipped, rotated, duplicated or segmented within eFilm Scan. Next, users can order these images and either send them as DICOM 3.0 studies, with relevant patient information, directly to a PACS or burned to a CD. Merge specializes in the deelopment of medical imaging systems.

• Meridian Bioscience (Cincinnati) reported launch of two new rapid tests for Epstein-Barr Virus (EBV): TRU EBV-M and TRU EBV-G. The TRU EBV tests use recombinant antigen technology to detect IgM and IgG antibodies specific to EBV. EBV is the primary cause of infectious mononucleosis and has been implicated in a number of benign and malignant disorders, including Hodgkin's disease and certain lymphomas. The current rapid methods for the diagnosis of infectious mononucleosis rely primarily on the patient's symptoms and non-specific heterophile antibody testing. The TRU EBV tests, however, are highly sensitive for specific antibodies that can classify acute and chronic stages of the disease. The TRU EBV test system is a simple, sensitive and rapid approach that allows healthcare providers to more precisely diagnose EBV infections. Meridian specializing in making diagnostic test kits.

• Interim results from a study conducted in patients with atrial fibrillation demonstrated that a port access, paracardioscopic Ex-Maze procedure produced favorable outcomes and allowed patients to discontinue antiarrhythmic drugs. Epicardial lesions to complete the bi-atrial pattern were created in all patients by coagulating cardiac tissue using the nContact Surgical (Morrisville, North Carolina) VisiTrax device. nContact makes products for the coagulation of cardiac tissue.

• NeoVista (Fremont, California) said that the FDA has granted the company's request to expand the number of sites participating in its pivotal Phase III trial from 10 to 30 in the U.S. The expansion of the CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy (CABERNET) trial, evaluating the safety/efficacy of the company's epiretinal brach-ytherapy for the wet form of age-related macular degeneration (AMD), was dependent on the FDA's review of 90-day safety data, typical of new-to-market medical devices. The study will evaluate the safety and efficacy of NeoVista's epiretinal brachytherapy, delivered using a limited vitrectomy, concomitant with two intravitreal injections of the FDA-approved antiangiogenic therapy Lucentis (ranibizumab) versus Lucentis alone. "With this expansion to 30 sites, we will not only be able to recruit more patients at a higher rate, taking us one step closer to commercialization in the U.S., but it will also allow additional retina specialists to see the benefits of our novel therapy first-hand while treating their patients, said John Hendrick, president/CEO of NeoVista. "We are getting closer and closer to seeing our investigational therapy become an approved treatment option for millions of patients worldwide afflicted with wet AMD.

• Nymox Pharmaceutical (Hasbrouck Heights, New Jersey) reported the publication of independent studies finding that the company's NicAlert saliva product provides a convenient and cost-effective way to verify self-reported smoking status, with broad potential applications both in the clinic and in large research trials and surveys. NicAlert can be used with either urine or saliva samples to provide an accurate visual read-out on a person's tobacco use or exposure within minutes by measuring levels of cotinine, a byproduct of the breakdown of nicotine in the human body.

• Olympus (Center Valley, Pennsylvania) reported that its AU680 mid-size chemistry analyzer offers a fully automated HbA1c assay. HbA1c assays are commonly ordered laboratory tests used to ascertain blood glucose levels over a three-month period. The throughput range of the AU680 reaches up to 1200 tests per hour by way of Olympus' 125-test menu that includes general chemistries, ISEs, special chemistries, thyroids and Syva Emit, TDMs and DATs. The system accommodates pediatric sampling and can perform automated pre-dilution and STAT processing without workload interruption. The Olympus Olympus Diagnostic Systems unit makes chemistry-immuno analyzers, lab automation systems, blood bank analyzers and reagents.

• PerkinElmer (St. Louis) reported the launch of its Victor X multilabel plate reader platform, the latest edition of the company's Victor series of multi-label detection instruments, used by research labs, including academic centers, pharmaceutical and biotech screening labs, drug discovery groups, and disease and therapeutic area research groups. The enhanced software package features an improved "Start Wizard for easier creation of new protocols; application-based example protocols for off-the-shelf use; and improved kinetics support for monitoring cellular and enzyme assays in real-time. PerkinElmer specializes in the areas of health sciences and photonics.

• Polymedco (Courtlandt Manor, New York) reported the introduction of the Pathfast immunoassay analyzer. The Pathfast rapid point of care system uses a chemiluminescent technology combined with a magtration separation method that allows this system to report highly accurate results that compare to large platform instruments. The Pathfast system can handle six samples in batch or random access mode and report these six results in 17 minutes. The system includes a computer, LCD touch screen and printer. Polymedco specializes in developing diagnostic equipment.

• Royal Philips Electronics (Amsterdam, the Netherlands ) reported that an addition to its HD ultrasound family of products, the Philips HD7, has launched in the U.S. The company said that the system draws upon "an array of features and capabilities available on high-end Philips systems and puts them into an affordable, mobile unit that is well-suited for a wide variety of clinical settings. The system provides grayscale and color Doppler imaging with simple one button optimization, as well as tissue harmonic imaging. In addition, the HD7 features a wide array of transducers, an adjustable flat panel LCD monitor, proven system architecture, and advanced imaging, measurement and quantification technologies. "The HD7 has a broadband digital beamformer to capture and preserve more tissue information than conventional narrowband systems and range and digital focal tuning provide exceptional sensitivity and detail resolution, according to the company. Philips makes diagnostic imaging and patient monitoring systems.

• Rubbermaid Medical Solutions (RMS; Huntersville, North Carolina) reported the launch of a medication expansion pack for its M38 mobile computer cart line. This secure storage system, which is available for the recently released M38 powered and non-powered computer carts, creates a hybrid of traditional computer and medication carts. The cart line features are multiple drawer sizes, keyless entry system with PIN code management and a bar-code scanner. RMS makes mobile carts and mobile computing solutions for healthcare facilities.

• The S&N Endoscopy Division (Andover, Massachusetts) of Smith & Nephew (London) reported the launch of the Footprint PK suture anchor, a system used to attach rotator cuff tissue to bone in the shoulder. Early approaches to cuff repair included transosseous tunnel repairs, which are still done today in some medical practices. During this procedure, the surgeon drills bone tunnels through the humeral head and laces sutures through them. The Footprint PK suture anchor delivers a transosseous equivalent repair without the need for drilling transosseous bone tunnels. Its two-piece design allows for the shell of the anchor to be tapped into place. Then, independent of implantation, an inner plug is advanced, which secures the sutures running from the other anchor rows. S&N specializes in systems for orthopedic reconstruction, orthopedic trauma and clinical therapies, endoscopy and advanced wound management.

• SheerVision (Rolling Hills Estates, California) reported launch of its new FireFly Infinity Ultra headlight system. The main enhancement of this headlight system is a new lithium-polymer battery and charging system. The FireFly combines a 54,000+ Lux beam, with a lightweight, powerful lithium-polymer battery. The FireFly weighs less than one ounce and has a light life of 50,000 hours. SheerVision makes surgical loupes and light systems.

• Sirtex (Wilmington, Massachusetts) has received FDA approval under an Investigational Device Exemption to conduct the first clinical trial to evaluate the safety of concurrent administration of FOLFOX6 and bevacizumab, an anti-angiogenic, with selective internal radiation therapy (SIRT) using SIR-Spheres microspheres as first-line treatment of patients with colorectal cancer that has metastasized to the liver. SIRT is a treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumors. In a minimally invasive treatment, millions of radioactive SIR-Spheres microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue. Sirtex specializes in the development of cancer therapies.

• SunTech Medical (Morrisville, North Carolina) reported the launch of the Advantage hemodialysis monitoring OEM non-invasive blood pressure (OEM NIBP) technology designed for monitoring blood pressure during hemodialysis. This application-specific technology recently achieved an "A rating for both systolic and diastolic blood pressure measurement according to the protol established by the British Hypertension Society (Leicester, UK), according to SunTech. The company said it sought to address concerns over the accuracy of automated blood pressure measurements on hemodialysis patients. It investigated an oscillometric blood pressure technology for end-stage renal disease (ESRD) patients during hemodialysis. Current validation protocols and guidelines do not require blood pressure monitors to be validated on specific patient populations. Consequently, most are validated on readily available healthy volunteers. In this regard, special efforts were made by focusing not only on ESRD patients, but in the environment for which the technology was intended by performing the evaluation during dialysis treatment. SunTech specializes in making non-invasive blood pressure monitoring products.

• SynCardia Systems (Tucson, Arizona) reported the introduction of the prototype of its new 4-pound Companion II Driver, calling it the next step in its Companion Driver System series. The Companion Drive System is designed to be docked into the Companion Hospital Cart for use in the operating room and intensive care unit. Once the CardioWest artificial heart patient is stable, the Drive Unit is designed to be re-docked into the Companion Discharge Caddy for mobility around the hospital and recovery at home. SynCardia Systems makes the CardioWest temporary total artificial heart.

• Synthetic Blood International (Costa Mesa, California) said it has filed a clinical protocol with the FDA for its planned Phase II-b clinical trial of Oxycyte in traumatic brain injury patients. Oxycyte is the company's perfluorocarbon therapeutic oxygen carrier and blood substitute. Synthetic Blood makes pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring.

• Tornier (Edina, Minnesota) and Tepha (Lexington, Massachusetts) said that an initial series of patients have been treated with the TephaFlex absorbable suture. Tepha said that the TephaFlex suture is derived from a new class of polymers called polyhydroxyalkanoates. The Tepha PHA family of polymers is a product of its patented recombinant DNA technology which allows the engineering of materials with mechanical and biologic properties that are matched to specific tissue repair and replacement applications. Tornier makes extremities orthopedics.

• Vestara (Irvine, California) reported the launch of the EcoRexNS pharmaceutical waste management system, an automated, integrated system that helps healthcare facilities to meet or exceed Federal regulations for pharmaceutical waste-handling. The EcoRexNS features a barcode scanner and a touch screen to help hospital staff classify waste as infectious, chemotherapeutic, hazardous, mixed hazardous/infectious or lower risk. Once the type of waste is identified, EcoRexNS opens the appropriate tamper-proof container automatically. Vestara makes pharmaceutical waste-removal systems.

• VisEn Medical (Woburn, Massachusetts) reported launch of its FMT 2500 small-animal imaging system, based on VisEn's fluorescence molecular tomography (FMT) technology platform, and combined with VisEn's portfolio of fluorescence in vivo imaging agents, assists researchers to generate quantitative data on disease biologies and therapeutic response profiles in animal research models. The FMT platform enables quantitative tomographic in vivo data by using three key steps: data generation, data normalization, and fluorescence tomographic reconstruction. Using a FMT 2500 animal imaging cassette that is compatible with multiple imaging modalities, researchers can also co-register FMT data with imaging readouts from other modalities, including CT, MR and PET. VisEn focuses on the development of fluorescence in vivo imaging.

• W.L. Gore & Associates (Flagstaff, Arizona) reported the availability of GORE BIO-A tissue reinforcement, a synthetic matrix material that encourages tissue generation in soft tissue reinforcement applications. GORE BIO-A tissue reinforcement is a web of biocompatible synthetic polymers that is gradually absorbed by the body, while its 3-D matrix of open, highly interconnected pores serves as a scaffold for tissue generation. The material is engineered to undergo hydrolytic and enzymatic degradation, leaving no permanent material in the body. GORE BIO-A is intended for use in the reinforcement of soft tissue and has a wide range of applications. The family of Gore Medical products includes vascular grafts, endovascular and interventional devices, surgical materials for hernia repair, soft tissue reconstruction, staple line reinforcement, and sutures for use in vascular, cardiac and general surgery.

• Zila (Phoenix) reported FDA clearance for its ViziLite eyewear, describing it as reusable filtered eyewear to be worn by a healthcare professional to eliminate ambient light while performing an oral exam under chemiluminescence when a darkened room is not available. ViziLite only allows transmission of light necessary for a ViziLite examination while blocking interfering ambient light from the practitioner's field of view. ViziLite is an oral screening technology that uses a chemiluminescent light source and a pharmaceutical-grade vital tissue dye. Zila is a developer of oral diagnostics.