ThyroTest, a new rapid hypothyroid diagnostic screening device from ThyroTec (Honey Brook, Pennsylvania), has received a CLIA waiver that will allow for detection of a common thyroid disease, much sooner rather than later, for millions of Americans and most likely at a lower cost to the overall healthcare system. Currently patients suffering from symptoms of hypo-thyroidism have to wait days to discover lab results, the company said. Although ThyroTest received FDA approval in July 2003, it most recently also gained CLIA waiver status, allowing patients to get test results for hypothyroidism in minutes, right in the physician's office.
The CLIA waiver will increase by "10-fold" the number of healthcare offices approved to administer the test, said Jim Small, president and CEO of Thyro-Tec. "We are excited about bringing ThyroTest to the marketplace," Small said. "[It] is the first, and only, product to receive FDA approval and CLIA waiver for identifying above-normal levels of thyroid stimulating hormone [TSH] in a rapid format. This simple, rapid diagnostic screen test is a qualitative measurement that allows physicians to screen patients for hypothyroidism in 10 minutes with a whole blood sample."
The stick test, which must be administered by a healthcare professional, is lateral flow technology and measures elevated TSH, or about 5 micro ius per ml. That would be a positive level, which is an indicator of hypothyroidism, he said, noting that it would be "not a definitive diagnostic" but a "strong indicator" of hypothyroidism.
A healthcare worker uses two drops of whole blood and follows that with six drops of "buffer" that will flow past a point on the test that has antibodies that will react to sufficient levels of TSH to cause a stripe to appear, which would indicate a positive test.
Elsewhere in the product pipeline:
Advanced Neuromodulation Systems (ANS; Plano, Texas) reported receiving FDA approval to market its first-generation rechargeable spinal cord stimulation systems, the Genesis RC and Genesis RC Dual (IPG) Neurostimulation Systems. Chris Chavez, president and CEO, said that ANS "is now the only company in the world that offers a full array of spinal cord stimulation devices, including radio-frequency, non-rechargeable IPGs, and now rechargeable IPGs."
Aethlon Medical (San Diego) said that its Hemopurifier treatment technology has demonstrated multipathogen clearance capabilities that could lead to a simultaneous treatment for persons infected with both HIV and the hepatitis C virus (HCV). The Hemopurifier is a medical device that converges the use of hollow-fiber dialysis technology with affinity chromatography to separate and selectively capture viruses and toxins from the blood. Enhancements to the Hemopurifier include the immobilization of a single affinity agent that is able to attach to the surface of both HIV and HCV. Aethlon is targeting the HIV-Hemopurifier to be a conjunction therapy to enhance and prolong established HIV drug regimens, and to serve as a treatment option for drug-resistant HIV patients. An HCV-Hemopurifier is being developed for treatment-resistant HCV patients.
AngioDynamics (Queensbury, New York) reported the release in the U.S. of the EvenMore chronic hemodialysis catheter designed for long-term use in dialysis patients. The EvenMore catheter is a non-position-dependent, 14.5 Fr, end-hole design catheter. Offering less than 5% recirculation, the catheter's low-profile, lumen-to-wall ratio is designed to deliver high flow. The catheter also features a Durathane shaft and a biocompatible and durable material that offers high chemical resistance, which helps simplify site care since the material can be cleaned with either iodine or alcohol. AngioDynamics will be providing the EvenMore catheter in a kit that includes the EmboSafe Valved Splittable Sheath dilator, a sheath designed to reduce the risk of blood loss and air intake while allowing for smooth catheter insertion.
Angiotech Pharmaceuticals (Vancouver, British Columbia) and Orthovita (Malvern, Pennsylvania) reported the commercial launch of Vitagel. Orthovita has initiated distribution through its 40 direct sales representatives and roughly 20 independent distributors. The direct representatives will have a launch base that extends to more than 500 hospitals. As part of the previously reported consolidation of its Cohesion Technologies subsidiary, Angiotech said it expects a full transfer of production capabilities from Cohesion's Palo Alto, California, facility to Orthovita's Malvern facility to be complete by 3Q05. Vitagel Surgical Hemostat is designed for use in cardiovascular, orthopedic, urologic and general surgery indications to control bleeding. Vitagel uses autologous blood, thus reducing the risk of transmission of diseases associated with donor blood.
ArthroCare (Sunnyvale, California) said it has received notice from the FDA that its Parallax Acrylic Resin with Tracers Bone Cement Opacifier has been cleared for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). The FDA clearance also coincides with ArthroCare's launch of a new version of its Parallax Acrylic Resin featuring a proprietary type of tantalum. This product, currently cleared for use in cranioplasty, is designed to enhance the physician's ability to track the flow of bone cement under fluoroscopy. ArthroCare said it intends to seek 510(k) clearance for use of the tantalum opacified cement in vertebroplasty or kyphoplasty procedures during 1Q05.
AusAm Biotechnologies (New York) reported that its Accumin test for detection of the protein albumin in urine will be offered by Quest Diagnostics (Teterboro, New Jersey). The presence of relatively high levels of albumin in the urine, a condition known as microalbuminuria, is an indicator of elevated risk for developing cardiovascular disease complications and kidney disease. The test will be available to hospital-based physicians nationwide in 1Q05.
Bausch & Lomb (Rochester, New York) reported that the FDA has accepted for review the new drug application for its Retisert intravitreal implant for non-infectious uveitis affecting the posterior segment of the eye. The implant is designed to deliver to the back of the eye a sustained release of the well-known steroid fluocinolone acetonide for up to three years. The application has FDA fast-track status, and the implant also has received FDA orphan drug designation for this indication. The company is targeting commercialization of the product this year.
Beckman Coulter (Fullerton, California) reported adding an application to its Coulter LH 750 hematology analyzers that automates the analysis of body fluids for greater lab efficiency and labor savings. With the new application, laboratories using the LH 750 can analyze three types of body fluids: cerebrospinal fluid (CSF), serous fluids (pleural, peritoneal, pericardial) and synovial fluids (pretreated with hyaluronidase). The automated process improves test turnaround time and enhances overall lab productivity. The body fluid application also helps labs eliminate errors associated with manual cell counting, such as errors in fluid dilution, counting errors in samples with low cell counts, and calculation errors associated with the conversion of the manual chamber count to reportable results, Beckman Coulter said. The LH 750 with body fluid analysis performs automated cell counting and immediately displays results for red blood cells (RBCs), white blood cells (WBCs) or total nucleated cells. The system indicates if the tested sample is a body fluid or a whole blood sample. The system's standardized testing method performs calculations based on units used in complete blood counts and evaluates a large number of cells within an established linearity range. This helps reduce variability of low and high counts for WBC and RBC analysis.
Biolase Technology (San Clemente, California) said it has been granted a U.S. patent protecting key areas related to its laser pulse technology. Patent No. 6,821,272 has broad claims related to the laser pulse technology used in the Waterlase and Waterlase MD hardand soft-tissue lasers. The patent is a continuation of previously granted patent No. 6,288,499, and has 111 claims, of which seven are independent. Method and apparatus claims cover the use of laser pulse technology, which allows the laser system to effectively interact with the water spray to produce a fast, clean and precise cutting action.
Bio-Rad Laboratories (Hercules, California) reported that it has received FDA clearance for its BioPlex 2200 system, a new immunoassay platform that uses multiplexing technology to analyze for multiple disease states from single patient samples. It is the first clinical diagnostics platform to offer multiplexing technology on a fully automated, fully integrated random access platform, according to the company.
Biotronik (Lake Oswego, Oregon) reported the first implant for a clinical investigation designed to demonstrate efficacy of both its Stratos LV and Protos DR/CLS (closed loop stimulation) pacemakers in congestive heart failure (CHF) patients who have undergone AV nodal ablation (ablate and pace) for persistent or permanent symptomatic atrial fibrillation (AF) with poorly controlled rapid ventricular heart rates. William Bailey, MD, of the Heart and Vascular Center (Lake Charles, Louisiana) implanted a Protos DR/CLS pacemaker in a biventricular configuration in a 72-year-old man. The AVAIL CLS/CRT study randomizes patients into three groups: Stratos LV biventricular implants; Protos DR/CLS biventricular implants; and Stratos LV pacing in a standard right ventricular configuration as the control group. The primary endpoint is to demonstrate the clinical benefit of biventricular pacing for the Class II and Class III heart failure population who also have permanent AF and have undergone AV nodal ablation. The results will be compared to the traditional right ventricular pacing study arm.
CardioDynamics (San Diego), the primary developer of Impedance Cardiography (ICG) technology, a predictor of short-term outcomes for heart failure patients, reported that its third-generation product platform, the BioZ Dx, has received FDA 510(k) market clearance. The company said that the BioZ Dx represents the first phase of a co-development partnership between it and Philips Medical Systems (Andover, Massachusetts) that leverages each company's technology and expertise. The BioZ Dx will be upgradeable to include Philips' 12-lead electrocardiogram (ECG) technology in late 2005. CardioDynamics CEO Michael Perry said there are two significant levels to the incorporation of Philips' technology into the BioZ Dx system. On the first level, he said that the system "provides the physician[s] with additional capability in a single product; they perform both the electrical and mechanical assessment of the heart in one device."
CardioGenesis (Foothill Ranch, California) reported receiving FDA approval of the SolarGen 2100s, an advanced laser console for performing angina-relieving transmyocardial revascularization (TMR). Michael Quinn, chairman and CEO, said that the SolarGen 2100s "is the first in a series of significant, advanced product offerings intended to expand the TMR market." CardioGenesis said it is preparing launch of the advanced TMR products, which it is naming the TMR PLUS platform. The TMR PLUS will include a range of minimally invasive delivery systems designed to reduce the morbidity associated with standard open surgical techniques, while adding features to enhance the ability to visualize and treat all targeted areas of the left ventricle.
Chembio Diagnostics (Medford, New York) reported that it has completed multi-center clinical trials on two HIV rapid tests, HIV Stat Pak and Sure Check HIV, with results that meet FDA expectations for specificity and sensitivity. The completion of these clinical trials enables the company to submit a completed premarketing approval to the FDA, which it said it expects to do soon. Each of these rapid tests provide results within 15 minutes, thereby allowing individuals who are tested to learn their HIV status at the time the test is taken. A total of 2,700 patients were tested from low-risk and high-risk populations and individuals known to be HIV-positive. Samples of finger-stick whole blood, venous whole blood, serum and plasma were collected from the participants in sufficient quantities to run on each of Chembio's tests and to then confirm such test results against a sequence of laboratory reference tests. Chembio said there were no discrepancies between sample types or between the two tests.
Dade Behring (Deerfield, Illinois) said it will begin to offer laboratories the Dimension Xpand Plus System, a second-generation integrated analyzer, building on its Dimension Xpand System, which it calls "the only chemistry analyzer to offer true integration of chemistry and immunochemistry testing for the low-volume laboratory." The Xpand Plus analyzer extends the Xpand system by offering more automated features. Enhanced instrumentation offers the clinical laboratory improved productivity and efficiency, while maintaining a simple, flexible, and highly capable design. The Xpand Plus integrated chemistry analyzer complements the productivity enhancement features found on the RxL Max analyzer, by offering more than 85 frequently ordered tests; programmable sample integrity analysis and documentation; and a flat touch screen monitor with a new articulating arm and keyboard tray for improved ergonomics and ease.
Durect (Cupertino, California), a developer of advanced drug delivery systems and pharmaceuticals, reported that in conjunction with Voyager Pharmaceutical (Raleigh, North Carolina), it has received FDA approval of its investigational new drug application and clinical protocol for an implant/drug combination to treat Alzheimer's disease. The combination uses a Durin-based leuprolide acetate. Objectives of the clinical study are to determine the safety and tolerability of the Durin leuprolide implant and to evaluate the product's pharmacokinetic profile. The Durin implant is small, about the diameter of the wire of a paper clip and only about 1" in length. It normally is implanted under the skin of the arm between the bicep and triceps or, alternatively, around the trunk of the body. The drug is incorporated into the structure of the implant and will be released for a number of months, the company said. The trial will consist of a pharmacokinetic study of healthy individuals who have volunteered for the trial. Voyager is currently conducting, in parallel, two other Phase II trials with the Durin implant, one in women suffering Alzheimer's, the other in men suffering the disease. About 60% of the trial subjects will receive a drug-coated implant, the remainder receiving placebo. The companies' plan is to combine final results from the pharmokinetic study and the in-women trial with interim results from the in-man trial and have an "end of Phase II" meeting with the FDA sometime during 2005.
Exact Sciences (Marlborough, Massachusetts) reported that the New England Journal of Medicine (NEJM) has published the results of the company's multi-center study, the first-ever study of its stool-based DNA test, PreGen-Plus, vs. the most widely used fecal occult blood test, Hemoccult II. Researchers found that the company's non-invasive, stool-based DNA test for colorectal cancer was four times more sensitive than the fecal occult blood test (FOBT), the only other entirely non-invasive colorectal cancer screening test available today. The stool-based DNA test was able to detect all stages of colorectal cancer in an average-risk, asymptomatic population, including the earliest-stage, most curable colorectal cancers. These data were published in the Dec. 23 issue of NEJM. This multi-center study is the largest study to date involving the stool-based DNA test, as well as fecal occult blood testing, in community practice. It is also the first head-to-head comparison of a stool-based, multi-target DNA panel vs. Hemoccult II in asymptomatic, average-risk adults aged 50 and older. The study was conducted at 81 sites.
Eyetech Pharmaceuticals (New York) and its partner, Pfizer (New York), said the FDA has approved its potential blockbuster treatment of Macugen (pegaptanib sodium injection) for the treatment of neovascular, or wet, age-related macular degeneration (AMD), something that is expected to compete head-to-head with Visudyne, a treatment for the predominate form of wet AMD. AMD is the leading cause of irreversible severe vision loss in patients older than age 50 in developed countries. Eyetech CEO David Guyer said Macugen is "a novel treatment based on elegant science that for the first time targets the underlying cause of the disease, which led to our broad AMD label, including all lesion subtypes, and lesions."
Gen-Probe (San Diego) reported receiving FDA clearance for its Aptima Chlamydia Trachomatis (CT) assay, an amplified nucleic acid test that detects, on a stand-alone basis, the bacterium that causes the most common sexually transmitted disease (STD) in the U.S. Gen-Probe's primary amplified STD test is the Aptima Combo 2 assay, which simultaneously detects Chlamydia trachomatis and Neisseria gonorrhoeae (GC). Like the Aptima Combo 2 assay, the Aptima CT assay was cleared to detect CT from a wide variety of sample types: clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens. The Aptima CT assay can be run on Gen-Probe's semi-automated DTS instruments. Gen-Probe also has filed for regulatory clearance of its stand-alone Aptima GC assay, expecting approval in 1Q05.
Haemonetics (Braintree, Massachusetts) reported that its CardioPAT surgical blood salvage system has received FDA 510(k) clearance. The CardioPAT system allows surgeons to recover blood lost by a cardiovascular surgery patient during and after the surgery, and make the blood available for transfusion back to the patient. The company said the CardioPAT system is suited for providing autotransfusion to the off-pump, or beating-heart cardiovascular surgery. The system can salvage blood lost both in the operating room and during recovery in the post-operative intensive care unit. The company said it would begin customer acceptance trials at three U.S. sites. Full market release is expected this year.
iCAD (Nashua, New Hampshire), a developer of computer-aided detection (CAD) imaging technology and systems for the early detection of breast cancer and other medical applications, reported the release of its ClearLook CAD Image Characterization Package. ClearLook is used together with iCAD's Radiologist Review Station, which presents breast images marked to show suspicious features on a display screen typically located where mammographic films are read.
Imalux (Cleveland) reported that its Niris Imaging System, based on optical coherence tomography (OCT) technology, received FDA clearance. Imalux said it would begin broad-based marketing and sales efforts for the system in 1Q05. The company received initial clearance from the FDA last March to market the Imalux OCT Imaging System. Since then, it has received two additional FDA clearances, one for an accessory sheath for the imaging system probe designed to provide a microbial barrier and aid in positioning the probe. The second, and most recent, cleared the Niris Imaging System for commercialization.
Immunicon (Huntingdon Valley, Pennsylvania) reported that its CellTracks Endothelial Cell Kit has been released for sale for research use only. The CellTracks kit is used in conjunction with the company's CellTracks AutoPrep System for blood sample preparation and its CellSpotter Analyzer to capture, count and characterize circulating endothelial cells from whole blood.
Innovative Biosensors (IBI; College Park, Maryland) reported the launch of a rapid and ultra-sensitive test for the detection of E. coli O157:H7 contamination in foods. The E. coli O157:H7 detection system enables meat processors to test for the pathogen in less than five minutes. The system is based on Canary, a biosensor technology developed at the Massachusetts Institute of Technology (Cambridge, Massachusetts) and exclusively licensed to IBI. The assay protocol is simple, requiring minimal training and easy-to-use instrumentation. The company said the E. coli O157:H7 detection system is the first in a series of upcoming IBI products for rapid pathogen detection.
Innovative Medical Products (Plainville, Connecticut) has developed the Tibial Distractor as part of a line of patient positioning aids developed specifically for trauma surgery. The Tibial Distractor is designed as a patient positioning device to provide distraction and rotation for axial alignment during IM nailing, plating and bone-grafting procedures of the tibia. According to the company, use of the device eliminates the need to manually stabilize the leg throughout a procedure. This allows intra-operative imaging, with substantially reduced radiation exposure for surgical assistants. The autoclavable unit folds to fit into operating room sterilizers, and offers disposable, sterile, latex-free patient protective foam pads. Insertion of a calcaneal pin facilitates placement of the patient's foot into the bow of the unit, allowing maximum exposure, distraction, rotational alignment and stabilization through skeletal traction.
KeraCure (Chicago) reported that the first patients have been treated in a pilot study to test its investigational device called KeraPac. The device is comprised of human keratinocytes, grown on microcarrier beads and packaged in a unique patented dressing configuration. The KeraPac is placed externally on a clean wound and removed several days later. The company plans to enroll up to 15 patients with Stage III/IV diabetic foot ulcers. KeraCure received FDA approval to conduct the study in a single center at the General Clinical Research Center at the University of Michigan (Ann Arbor). The company expects to complete enrollment early this year. KeraCure said preliminary data would be analyzed of patients who complete a four-week active treatment phase with a four-week follow-up phase and will be presented to the FDA during 1Q05. The company said it will then seek FDA approval to initiate a multi-center pivotal trial in the U.S. in which an expanded number of sites will investigate the device.
Lumenis (Yokneam, Israel) introduced the Novus 3000 photocoagulator at the 2004 American Academy of Ophthalmology (AAO) conference in New Orleans. A successor to the Novus 2000, the Novus 3000 provides laser delivery in an integrated design for use in operating rooms for the treatment of retinal diseases. The Novus 3000 is a solid-state, diode-pumped laser providing 532nm laser light with a dual-fiber delivery output and a color touch-screen user interface. The Novus 3000 offers increased power, delivering up to 3.0 watts of laser energy, and has expanded the number of indications for the laser to include ophthalmic, surgical, aesthetic and dental applications. A full line of new laser delivery devices and accessories also will be available. Also at AAO, Lumenis introduced its new dual-port Spectra 532 nm laser system. The company said the Spectra is the most powerful portable 532 nm laser. The new dual-port version will allow the physician the convenience of an operating room laser in a portable model, Lumenis said.
Mallinckrodt (St. Louis), a Tyco Healthcare company, reported the introduction of the OptiVantage DH Contrast Delivery System for dual head injector protocols. The OptiVantage dystem enhances patient safety and outcomes with three safety features. The fully programmable LCD powerhead allows technologists to monitor patients during the procedure, keeping them on top of possible problems, enhancing safety and reducing testing time by 25%. OptiVantage allows the technologist to interrupt the injection with the push of a button, preventing irritation from extravasion of the saline. To reduce the risk of air embolism, the Tilt Enable feature allows an injection to occur only if the proper sequence has been followed and the powerhead is tilted downward.
MedicalCV (Minneapolis) said it received FDA 510(k) clearance to market its AtriLaze Surgical Ablation System for use on cardiac tissue in surgery. The company expected to begin marketing the AtriLaze System via a direct U.S. sales force in January. The laser device is used to ablate or cause scarring of soft tissue, with the long-term goal of treating atrial fibrillation.
Medtronic (Minneapolis) reported the first patient enrollment in a new controlled clinical study to evaluate the safety and efficacy of a procedure in which a heart surgeon uses saline-irrigated radio frequency (RF) ablation technology to treat atrial fibrillation (AF) at the same time they repair or replace a diseased or damaged heart valve. The first randomized procedure was performed by Dr. Michael Moront at Toledo Hospital of Ohio, one of several U.S. centers participating in the study. The CAFE (Cardioblate Atrial Fibrillation) study is the first prospective, randomized, blinded trial designed to study surgical ablation for the treatment of AF. The CAFE study will enroll adult patients suffering from both heart valve disease and AF. The Cardioblate system creates lesions in the heart's upper chambers to block transmission through the tissue of abnormal electrical signals that may cause AF.
NeoSurg Technologies (Houston), a developer of minimally invasive access products for laparoscopic surgery, received U.S. patent No. 6,830,578, covering the bladeless tip geometry for the T2000 Reusable Trocar System. The T2000 System consists of a reusable trocar constructed of titanium and hard anodized aluminum. The access tip is disposable, thus providng the surgeon with a choice of tip geometries, from a sharp and controlled penetration to a bladeless entry, so that the surgeon can choose a particular geometry without changing the entire instrument. A locking/shielding mechanism is attached to the main trocar to guard the tip during insertion.
Ortho Biotech Products (Bridgewater, New Jersey) reported the availability of a new, self-administered anemia-screening test, without cost, to people at significant risk for anemia from chronic kidney disease. AnemiaPro, recently approved by the FDA, was developed by Biosafe Medical Technologies (Lake Forest, Illinois). The single-use screening test enables people at risk for chronic kidney disease to check their blood for possible signs of anemia in the privacy and convenience of their homes. Ortho Biotech Products holds exclusive U.S. marketing rights for the product.
Orthofix International (Huntersville, North Carolina) reported that it has received FDA approval to market the company's Cervical-Stim bone growth stimulator as an FDA Class III device. The company said that this is the first FDA-approved bone growth stimulator for use as an adjunct to cervical spine fusion in high-risk patients. The FDA approved the Cervical-Stim based on a premarket approval application that included the results of a prospective, randomized, multi-center clinical investigation of Cervical-Stim led by Kevin Foley, MD, of the department of neurosurgery at the University of Tennessee (Knoxville, Tennessee).
RetinaPharma Technologies (Jenkintown, Pennsylvania) reported that it received FDA clearance to market its TonoPach, designed to enable more accurate diagnosis of glaucoma and ocular hypertension, leading causes of preventable blindness among adults. TonoPach, which is expected to be on the market by mid-2Q05, is the first device to enable simultaneous determination of intraocular pressure (IOP) and corneal thickness, increasing the accuracy and predictive power of the IOP measurement that is traditionally used alone. In addition, thinned corneas, which can result from laser vision corrective surgery as well as disease, can alter the IOP reading and mask underlying glaucoma.
RITA Medical Systems (Mountain View, California) said an article published in the November issue of Investigative Radiology reported improved long-term survival rates for 423 patients treated with radio frequency ablation (RFA) for hepatic colorectal metastases. The article reports that RFA provided "substantially higher" long-term (five-year data) survival rates for patients who are not surgical candidates and who are treated with chemotherapy alone.
Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of the GTS System for use in arthroscopic soft tissue reconstruction of the anterior cruciate ligament (ACL) in the knee. The GTS System is used to secure the lower, tibial end of a soft tissue ACL graft. Key to this system is the GTS Sleeve device, a woven mesh sleeve segmented into three tubular sections, called lumens. Two of these lumens hold graft tissue, and the third lumen accepts the GTS tapered fixation screw molded from bioabsorbable poly-l-lactic acid (PLLA). As this tapered screw is tightened, it presses the graft tissue against the sides of the tibial tunnel. The PLLA material biodegrades over several years and is dispersed from the patient's body naturally.
SonoSite (Bothell, Washington), a leader in hand-held ultrasound systems, said that it has begun customer shipments of the SonoCalc IMT software, enabling physicians to quickly measure the wall thickness (IMT) of the common carotid arteries to assess risk of cardiovascular disease. Used in conjunction with the Titan system SonoSite's high-resolution, hand-carried ultrasound technology the SonoCalc IMT software enables physicians to identify disease at an early stage for more effective management. The PC-based software works with digital images downloaded from the Titan system. SonoCalc IMT provides physicians with the ability to analyze the IMT of a patient's carotid artery and compare it with published population data to generate an individualized cardiovascular health profile report.
Sontra Medical (Franklin, Massachusetts) reported the completion of a randomized, double-blinded placebo-controlled clinical study of 77 children in the emergency department at Hasbro Children's Hospital (Providence, Rhode Island). The company's SonoPrep treatment creates imperceptible, reversible micro-channels through the stratum corneum thereby making the skin permeable to topically applied drugs. In this study, the SonoPrep ultrasonic device was applied to the skin for about 15 seconds. A 4% topical lidocaine or placebo cream was applied to the permeated skin site for five minutes. The children and parents were asked to rate pain on a visual analogue scale. The study demonstrated a significant reduction in pain experienced by children and perceived by parents during IV catheterization compared to the placebo.
Stratagene (La Jolla, California) reported the launch of its Mx3005P Real-Time PCR system, expanding on its quantitative PCR instrumentation systems. The open platform design of the Mx3005P system supports all fluorescent dyes and chemistries, including Stratagene's proprietary FullVelocity reagents.
VISX (Santa Clara, California) reported that it has received FDA approval to treat hyperopia, or farsightedness, and astigmatism with the VISX CustomVue laser vision correction procedure. The procedure is the first U.S.-approved wavefront-guided laser treatment for hyperopia. It uses the VISX WaveScan System, a diagnostic system that captures a comprehensive "fingerprint" of each eye and generates an individualized treatment for each CustomVue procedure.
W.L. Gore (Flagstaff, Arizona) said it received FDA approval to market the Gore Viatorr Endoprosthesis, an advanced technology, implantable device to treat portal hypertension in both de novo and revision Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures. The Viatorr Endoprosthesis is also indicated for the treatment of tracheobronchial strictures. The Gore Viatorr TIPS Endoprosthesis is a flexible, self-expanding, implantable endoprosthesis with a proprietary, reduced permeability expanded polytetrafluoroethylene graft lining. Featuring improved radial compression strength, the Viatorr is designed to provide secure anchoring with minimal kinking. The Viatorr TIPS Endoprosthesis is available in diameters of 8 mm, 10 mm and 12 mm, and its graft-lined length ranges from 4 cm to 8 cm. The endoprosthesis is delivered over a guidewire diameter of less than or equal to 0.038". Placement is via a 10 Fr introducer sheath.
Wright Medical Group (Arlington, Tennessee) reported the launch of the Profemur Tapered Stem Total Hip System. The rounded, tapered stem design reduces the potential for implant loosening and thigh pain and requires the removal of less bone from within the femoral canal. The tapered stem feature complements the Profemur system's modular neck design, which is specially suited for use with a smaller surgical incision. The Profemur Hip System is an integral part of Wright's Odyssey Tissue Preserving Initiative, a minimally invasive surgery program for hip, knee and total joint resurfacing procedures. The Profemur Hip System's modular neck feature simplifies implant insertion and reduces the risk of soft-tissue damage. The implant also provides improved stability and reduced procedure time.