Fempatch

* Aastrom Biosciences (Ann Arbor, Michigan) said the FDA approved the company's request for an inves-tigational device exemption to begin clinical feasibility trials of umbilical cord blood transplants to restore blood and immune system cells destroyed by chemotherapy in cancer patients. Aastrom's cell pro-duction system will be used to produce ex vivo stem cells from a small amount of umbilical cord blood for transplant to 30 adults and children for whom no matched bone marrow donors were found. * Advanced Tissue Sciences (La Jolla, California) received FDA approval of Dermagraft-TC as a tempo-rary wound covering for partial-thickness burns. The product - human, fibroblast-derived temporary skin substitute - was first approved for marketing in March as a temporary wound covering for severe burns. The broader labeling could increase Dermagraft-TC's mar-ket dramatically. According to the company, 1,500 peo-ple are severely burned each year, but 30,000 to 40,000 patients each year seek medical treatment for partial-thickness burns. * Amersham International (Little Chalfont, England) has increased the detection sensitivity for proteins in Western Blot tests by up to 25-fold by the use of the newly developed ECL Plus acridinium ester substrate technology. The substrate also provides a more intense and prolonged pattern of light output - significant lev-els can be readily detected on PVDF blots up to 48 hours after initial detection. * ArthroCare (Sunnyvale, California) has intro-duced three new ArthroWands for use in arthroscopic knee surgery. The wands, which are additions to ArthroCare's Tubo Dome line, offer improved access and maneuverability within the small spaces of the knee joint, especially those surfaces where most injuries occur. * Bayer's (Leverkusen, Germany) Advia 120 is an automated hematology analyzer and is the first in the new H line of analyzers developed by Bayer. In place of Bayer/Technicon tubing systems, the new H line uses Unifluidics technology with diluted samples circulat-ing in an optical quality acrylic block. As a result, main-tenance is reduced to a minimum. * Bayer Diagnostics (Munich, Germany) in collab-oration with Technology Partnership (Royston, Eng-land) has developed a self-test, blood-glucose device using conductivity changes resulting from a glycose-enzyme reaction on a test strip. Test strips are stored in a disc incorporated into the glucose meter, protecting them from humidity and light. * Becton Dickinson (Franklin Lakes, New Jersey) has launched in Europe the BACTEC MGIT 960 myco-bacterial culture system, which will accommodate up to 320 tubes in each of three incubation drawers. This capacity handles about 8,000 specimens per year based on a 42-day test protocol. * BioStar (Boulder, Colorado) has launched the Strep AOIA (Optical ImmunoAssay) Max point-of-care test for group A streptococcus. The second-generation version reduces the number of steps needed to perform the test, resulting in a reduction in the amount of time needed for an accurate diagnosis to be made, from 8 minutes to 5 minutes. * Bio-Technology General Corp. (Iselin, New Jersey) said a Phase I trial of a deep vein thrombosis (DVT) diagnostic, employing the company's genetically engineered fibrin binding domain (FBD) peptide, was begun by Draxis Health (Mississauga, Ontario, Canada), which licensed the peptide from Bio-Technology General. The test is called Fibrimage and uses FBD to bind to fibrin, the primary culprit of DVT. * Biotrin International's (Dublin, Ireland) GST EIA is a quantitative enzyme immunoassay for the detec-tion of alpha glutathione S-transferase (GST) which is a soluble enzyme found in hepatocytes and readily released in response to injury. The assay measures GST in serum, plasma, cell cultures and perfusate and can sensitively detect low levels of liver damage. * Blatchford (Basingstoke, England) has devel-oped a computer-controlled system designed to allow people with an artificial leg to walk more naturally. The Endolite Intelligent Prosthesis Plus system, which is rapidly programmable and microprocessor-controlled, controls knee movements, allowing transfemoral (above knee) amputees to walk more naturally over a wide range of speeds. * Otto Bock (Duderstadt, Germany) has launched a device similar to Blatchford's, fully programmable and computer-controlled to control knee movements, allowing people with an artificial leg to walk more nat-urally. * Codan Medizinische Gerate (Lensahn, Germany) has developed a new line of urological irrigation sys-tems and related devices to add to its existing line of infusion and transfusion devices and venous cannulae. * Cygnus (Redwood City, California) has launched FemPatch, a low-dose, seven-day estrogen replacement transdermal patch treating menopausal symptoms. Cygnus will manufacture the product and Sanofi, the worldwide licensee, has sub-licensed U.S. marketing rights to Warner-Lambert. FemPatch uses just .025 mg of 17 beta-estradiol and targets vasomotor symptoms such as hot flashes and night sweats. The mechanism of transdermal delivery avoids first pass metabolism through the gastrointestinal tract and the liver, thus requiring a much lower dose. * Cypros Pharmaceutical (Carlsbad, California) has selected coronary artery bypass grafting (CABG) surgery as the initial indication for CPC-111, a cardio-protective drug. This indication was selected on the basis of statistics showing significant improvements in a wide variety of end points observed in CABG patients, including measures of heart damage and recovery of post-surgery heart function. * Dantec Medical (Skovlunde, Denmark) has launched the Menuet Compact Plus urodynamic test system, which provides uroflowmetry, urethral pres-sure measurement, water, gas and voiding cystometry in one functional unit. Video urodynamics and caver-nosometry can be integrated into the system with optional modules. * Daxor Corp. (New York) has received FDA mar-keting clearance for its BVA-100 Blood Volume Analyzer which measures the total amount of blood in the human body. The BVA-100 is the only device of its type to receive a U.S. patent, and it has received patents in Europe and Japan. An instrument that is useful prior to surgery and some blood transfusion procedures, the BVA-100 provides blood volume measurement in 25 to 35 minutes and is accurate to plus- or minus-2%. * Diagnostic Grifols (Barcelona, Spain) will launch at this month's Medica show in Dusseldorf, Germany, its Triturus fully automated immunoassay analyzer system for use with ELISA microplate assays. The ana-lyzer is an open system accepting all microplate assays, although it is designed especially for use with Grifols' ELISA TORCH assays. * Diametrics Medical (St. Paul, Minnesota) received FDA marketing clearance for its Paratrend 7+ multi-parameter sensor for continuous monitoring of blood gases. * Digene (Beltsville, Maryland) has submitted a PMA supplement to the FDA for its Hybrid Capture II HPV DNA test, which permits simultaneous testing of multiple samples from a single 96-well microtiter plate. Preliminary studies indicate that, when used in con-junction with Pap smear testing, Capture II can detect 95% to 100% of high-grade lesions and virtually all instances of cervical cancer. * Disetronic's (Burgdorf, Switzerland) Multifuse infusion system can be programmed for use in continu-ous or intermittent infusion, chrono-infusion, patient-controlled analgesia and total parenteral nutrition. Programming can be carried out on the pump or via a PC and modem and delivery rates can be adjusted between 0.1 and 400 ml/hour. * Drager's (Lubeck, Germany) new Physio Flex total closed-circuit anesthesia system enables continu-ous gas regulation with automatic adjustments to uptake of oxygen, nitrous oxide and volatile anesthetic agents to achieve the desired balance as predetermined by the anesthetist. In quantitative anesthesia, the sup-ply of all the gases is equal to actual uptake by the patient. It is therefore possible to spot metabolic mal-functions at an early stage, such as malign hyperther-mia, recognizable by a significant increase in oxygen uptake. * Imatron (South San Francisco, California) pro-duces the Ultrafast CT (computed tomography) which performs a coronary artery scan called "the single best predictor" of cardiac obstructions, in a paper published in a recent issue of The American Heart Journal. The arti-cle, "Coronary Calcium: the Strongest Risk Factor for Coronary Artery Disease," compared the use of Ultrafast CT with traditional risk factors determined via coronary angiography in 368 patients. Ultrafast CT is a non-invasive coronary artery scan using Imatron's proprietary electron beam technology. * Immuno Quality Products (Groningen, the Netherlands) has developed the CMV Brite diagnostic kit which detects CMVpp65 antigen in blood samples to identify active human cytomegalovirus (CMV) infec-tions. The test is targeted at monitoring immunodefi-cient patients such as transplant recipients, HIV posi-tive and AIDS patients and patients on cancer therapy. * Integra LifeSciences Corp. (Plainsboro, New Jer-sey) received approval to market its Integra Artificial Skin in Taiwan. The permanent "dermal regeneration template" is marketed in about 19 countries, including the U.S. and Canada. It is helpful to burn victims, of which Taiwan has about 2,200 critical cases each year. * International Murex Technologies (Toronto, Ontario, Canada) has launched a new rapid latex agglutination assay for E. Coli 0157 and has applied for market clearance for a second rapid test for E. Coli H7. * Kenyaku Kogyo, the Japanese marketing partner of Cortecs International (London), has received Minis-try of Health and Welfare approval to distribute the Helisal Rapid Blood test, to be marketed in Japan as Helitest. It is the first whole-blood Helicobacter pylori rapid point-of-care test to receive approval in Japan and follows U.S. FDA approval gained last year. The rapid point-of-care test is designed to allow doctors to deter-mine in a few minutes whether a patient is infected with H. pylori. * LifeCell (The Woodlands, Texas) said expanded use of its AlloDerm acellular dermal graft were highlighted in three panel discussions at this year's meeting of the American Academy of Facial Plastic and Reconstructive Surgery in San Francisco. The expanded uses discussed included various rhinoplasty and nasal surgical proce-dures, as well as AlloDerm's use in combination with syn-thetic implants to provide more natural contouring. * NeoPath (Redmond, Washington) said a clinical study involving analysis of more than 31,500 slides from five major laboratories demonstrated positive results in use of its AutoPap System as a primary pap smear screener. * Nymox (Rockville, Maryland/Montreal, Quebec, Canada) has developed a new Alzheimer's disease test based on its NTB technology. Painless and non-inva-sive, the test detects critical marker molecules in urine and is being tested in patient trials, according to the com-pany. * Organon (West Orange, New Jersey) has received FDA marketing clearance for Follistim (follitropin beta for injection), the first recombinant follicle-stimulating hormone in the U.S. for treating infertility. The product is manufactured using DNA technology and stimulates the ovaries to produce one or more eggs per treatment cycle. It can be self-injected using a small needle for skin-deep injections, rather than the traditional deep muscle injections. * Palatin Technologies (Princeton, New Jersey) has submitted to the FDA an investigational new drug application for LleuTech, its kit-packaged, radio-labeled infection imaging system. Injected intravenous-ly, LeuTech binds with white blood cells at infection sites within the body, allowing such sites to be imaged using conventional planar imaging techniques. * Pharmacia & Upjohn Diagnostics (Uppsala, Sweden) will be introducing its new top-of-the-line allergy test sys-tem at this month's Medica exposition. The Uni CAP 1000 is a fast, high-capacity, fully automated platform designed for medium- to large-sized clinical laboratories specializing in allergy, asthma and autoimmunity testing. * Quadra Logic Technologies (QLT; Vancouver, British Columbia, Canada) has obtained German mar-ket approval for Photofrin (porfimer sodium) PDT ther-apy in early-stage lung cancer. Beaufour Ipsen (Paris), which is European marketing partner for QLT, plans 11 further submissions in Europe this year. Photofrin already is approved in France and the Netherlands. * Roche Diagnostic (Basel, Switzerland) has devel-oped the Unimate fructosamine assay which uses all liquid reagents and is designed for use in diabetes monitoring using the COBAS automated clinical chemistry systems. * Scios (Mountain View, California) and Wyeth-Ayerst (Radnor, Pennsylvania), the pharmaceutical divi-sion of American Home Products (Madison, New Jersey), have begun Phase II/III clinical studies of Fiblast trafermin, a basic fibroblast growth factor to treat stroke. The two studies will involve more than 1,800 patients at centers in the U.S. and Europe and fol-low earlier research demonstrating the product's ability to protect neurons from the damaging effects of stroke, including oxygen and glucose deprivation. The two companies began collaborating in 1996 to develop the product for both neurological and cardiovascular disor-ders. * Second Opinion Solutions (Oslo, Norway) incorporates an innovative software design into its Pathsight telepathology system which is designed for use across the whole range of histopathology and cytopathology. The system provides easy-to-use diag-nostic digital quality images and dynamic remote con-trol of the microscope. * Siemens (Erlangen, Germany) has launched two new, high-field magnetic resonance imaging systems, the Magnetom Harmony (1 Tesla) and Magnetom Symphony (1.5 Tesla), both of which are designed to be significantly smaller than previous models, and with integrated computer cooling systems. Siemens said that both patient set-up time and imaging time have been shortened, allowing a faster throughput of patients without sacrificing image quality. * Siemens Medical Systems' Nuclear Medicine Group (Hoffman Estates, Illinois) received FDA clear-ance for its E.Cam+ coincidence imaging option, which expands the clinical diagnostic capabilities of the E.Cam variable-angle photon emission camera for computed tomography. * Trinity Biotech plc (Dublin, Ireland) has begun shipping Negoplasma EIA tests, which received FDA marketing approval recently. Produced in the micro titre format, the test detects mycoplasma pneumonias, which make up about 20% of the 4 million pneumonias contracted in the U.S., most frequently among children. The company manufactures about 90 tests, including about 60 EIA tests sold in the U.S. * Unipath's (Bedford, England) new rapid Clearview Chlamydia MF immunoassay test can be used with either swab samples in women patients or urine samples with men. Until now, screening for chlamydia has been largely limited to women since tak-ing samples from men has involved the uncomfortable procedure of urethral swab sampling. Easy urine sam-pling should significantly simplify male chlamydia screening programs. * Valley Forge Scientific (Oaks, Pennsylvania) has received a patent for its disposable bipolar cutting loops, used in conjunction with its proprietary bipolar electrosurgical systems for neurosurgery, plastic sur-gery, gynecology and laparoscopic surgery. The loops enable surgeons to cut tissue with little blood loss or current spread and can be used in irrigated or dry sur-gical fields. The company received FDA marketing clearance for the devices last year * Visual Interface (Pittsburgh, Pennsylvania), spe-cialist in medical shape photography, has begun the final testing of the Virtuoso shape camera, which the company describes as the first 3-D imaging device that works like a camera. Portable and battery-pow-ered, the Virtuoso requires no in-field calibration and captures its images instantaneously. Primary applica-tions are for plastic surgery, orthopedics, prosthetics design and wound healing. Studies are under way using the instrument to evaluate the effectiveness of different techniques for cleft lip repair, to monitor the effects of growth on positioning of prosthetic devices and evaluation of different liposuction methods. Visual Interface plans to create a virtual reality mod-eling language file which can be viewed on the Internet.

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