Xigris Pulled From Worldwide Market
Eli Lilly is withdrawing activated drotrecogin alfa (Xigris), a drug intended to treat severe sepsis in high-risk patients, from all markets including the United States as well as discontinue all ongoing clinical trials involving the drug in the wake of a new study showing that the agent did no better than a placebo in reducing mortality.
Ongoing studies could not reproduce the initial efficacy results reported by a pivotal clinical trial called the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) trial. The committee asked the manufacturer to conduct a new test to confirm that “the benefits of Xigris outweigh its risks to patients with septic shock.” The new study, called PROWESS-SHOCK, reported a 28-day all-cause mortality rate of 26.4% in patients treated with activated drotrecogin alfa compared with 24.2% in the placebo group of the study, according to the EMA, which did not deem the difference statistically significant. The risk for severe bleeding events, the main risk of the drug, was 1.2% and 1.0% for the activated drotrecogin alfa and placebo groups, respectively.
KingVISION Video Laryngoscope
Indiana-based King Systems has introduced their KingVISION video laryngoscope system which consists of a reusable lightweight, modular, 2.4″ non-glare, scratch-resistant QVGA color OLED display powered by standard AAA batteries mated to disposable, rigid polycarbonate/ABS standard or channeled MAC 3 blades with self-contained VGA CMOS camera optics and a white LED light source. The standard blade fits in mouth openings as small as 13mm while the channeled blade (used to facilitate advancement of an endotracheal tube through the glottis) fits mouth openings as small as 18mm, which should accommodate the majority of adult airways.
Other benefits of the KingVISION system include having no moving parts or joints that may become a point of failure between electronic contacts, and the entire system is inexpensive relative to most other portable self-contained video laryngoscopes on the market today. http://www.owntheairway.com/
Masimo received FDA clearance and CE Mark of approval for the Radical-7 non-invasive pulse oximeter with rainbow Acoustic Monitoring technology that provides continuous readings of the acoustic respiration rate (RRa) waveform and measurements. A new feature on the system, not yet approved by the FDA, called In Vivo Adjustment, allows clinicians to calibrate the device to individual patients and to readings from reference quality invasive blood analysis devices.
The new Radical-7 provides clinicians with the option to measure RRa and display the acoustic waveform directly on the monitor screen with the pleth waveform overlayed—allowing them to observe changes in breathing upon inhalation and exhalation. With this new display capability, clinicians may be able to more readily detect respiratory pause events where there is an absence of breathing, high ambient noise that can degrade the acoustic signal, and improper sensor placement.
The measurement of blood components such as oxygen saturation, methemoglobin, carboxyhemoglobin, and total hemoglobin have inherent and expected variability within and between noninvasive and invasive measurement techniques and from patient to patient. For example, all of the noninvasive measurements use a technique coined ‘patient calibration’ which takes the noninvasive monitor’s detected light that is transmitted or reflected from the patient at different values and matches them to empirically gathered invasive blood measurements from a small number of volunteers and in some cases patients. However, individuals may vary from the pool of patients used in the ‘patient calibration’ and hence provide a bias for the particular patient. In addition, many clinicians are unaware that laboratory reference devices that measure oxygen saturation or hemoglobin can have great variability from each other. In fact, hemoglobin can vary 2 g/dL or more from one manufacturer’s product to another. And, physiologic factors such as the blood source (venous or arterial), site and time of blood draws, blood draw technique, and patient body position are recognized in the clinical literature to add variability to hemoglobin levels. As a result, noninvasive and invasive measurements can vary in the same patient depending on the methods and invasive equipment used.
The In Vivo Adjustment feature available in the new Radical-7 now provides the option to adjust the noninvasive oxygen saturation (SpO2), total hemoglobin (SpHb®), carboxyhemoglobin (SpCO®), and methemoglobin (SpMet®) values displayed on the monitor to the laboratory reference value used at the site by patient. With this new feature, clinicians can adjust the noninvasive value at the beginning of a monitoring period to account for individual patient variation and the laboratory reference value and continuously trend the noninvasive value to the patient and reference laboratory value until the next blood sample and laboratory analysis.
First Portable VeinViewer
Christie Medical Holdings’ has announced the VeinViewer Flex, the first portable offering in the company’s VeinViewer line. VeinViewer technology projects an image of a patient’s blood vessels directly onto the skin in real time by detecting their location using near-infrared light, and is used to aid in needle placement. Flex is designed to the same TrueView vein-width accuracy specifications of its predecessor, VeinViewer Vision, and is currently under testing. Additionally, Flex will feature a new software option, MaxBright, which boosts existing VeinViewer brightness by another 40 percent, making Flex one of the brightest near-infrared vein illuminators on the market.
Carticept Medical based outside of Atlanta, GA won FDA 510(k) clearance for the Navigator Delivery System (Navigator DS) that provides ultrasound guidance when delivering corticosteroids and anesthetic agents to painful joints. The system accepts up to three vials of different medications and avoids the step of manually loading a syringe straight from the vial. The Navigator DS prepares and delivers physician-prescribed injections from standard multi-dose anesthetic and steroid drug vials, eliminating needle exposures, minimizing the potential for contamination of the medication. Additionally, and ensuring accurate dose preparation and saves significant labor for a busy physician practice. The ultrasound screen provides the physician with realtime visualization of the needle position, fluid delivery process and prescription volume. After the injection is delivered, the system records the treatment data and automatically creates a record for transfer to an electronic record management system.
Smiths’ Medfusion 4000 Wireless Syringe Infusion Pump
Like its predecessor, the Medfusion 3500, the new model runs Smiths’ proprietary PharmGuard software that allows for easy management of infusion data and provides safety parameters to prevent incorrect dosing during anesthesia or in critical care areas. The new model provides wireless connectivity (802.11b/g) so that pump data can be managed remotely. PharmGuard® Toolbox Medication Safety Software – PC software allows pharmacists to develop drug libraries according to hospital-defined medication dosing best practices and then deploy them to Medfusion® 4000 pumps. PharmGuard® Server Software – a scalable and upgradeable web-based application enables the wireless collection, management, and Continuous Quality Improvement (CQI) reporting of patient infusion data to track trends in compliance with medication dosing and clinical best practices. SureLink™ Remote Support Software – an agent that runs in the background on a hospital’s Windows®-based workstation or server and allows Smiths Medical Customer Support specialists to monitor devices and software, diagnose problems, provide software installation and upgrades, and supply remote support of Smiths Medical products.
CIRCA Esophageal Temp Monitoring System Approved in US
CIRCA Scientific, a Park City, Utah company, received FDA clearance for its CIRCA S-CATH and CIRCA Temperature Monitoring System that together provide real time temperature monitoring from the esophagus.
The S-CATH features 12 thermometers that report their readings 20 times a second, and the catheter itself has a two-plane sinusoidal shape to cover a wide area of the esophagus. The CIRCA Temperature Monitoring System displays continuous readings, provides range alarms, and highlights the temperature of the hottest of the sensors. Has user selectable visual and audible warning and alarm
CS-2001 CIRCA S-CATH is a 10 French OD Esophageal Temperature Probe, 2-Plane radiopaque design and can be straightened for oral or nasal delivery
1st Arm Cuff Monitor Measures Central BP
Centron Diagnostics, a spin-out of King’s College London, recently released cBP 301 monitor that can measure peripheral and central systolic blood pressure with one upper arm cuff. It not only records the waveform of blood pressure at the arm, but uses a transfer function to calculate the central blood pressure with accuracy similar to radial tonometry. Its technology has been validated against invasive measurements of central aortic blood pressure.
Centron Diagnostics approach to estimating central systolic blood pressure is to obtain a peripheral blood pressure waveform from a brachial blood pressure cuff. Although such a waveform differs from that obtained using an intra-arterial sensor or from that obtained by tonometry, an appropriate transformation can be used to estimate cSBP with similar accuracy as that achieved by tonometry. This approach allows cSBP to be estimated at the same time as a routine oscillometric measurement of peripheral blood pressure with no extra equipment or expertise required. The peripheral blood pressures are derived using SunTech Medical’s fully validated oscillometric technology.
DHS Systems, a company that manufactures military tents, has unveiled XYTEX 500. It is used to modify the inside fabric of the tent to make the surface be full of nano sized spikes that can rapture cell walls. Bacterial pathogens flying around the tent, a space that can be dangerously crowded and full of patients with exposed wounds, will have a hard time making a safe landing, hopefully leading to fewer infections. The fabric is also resistant to mold, mildew, and fungus. The new fabric, XYTEX 500™, will offer 99.99% protection.
XYTEX 500™ is also fire retardant, water repellent and resistant to abrasion and ultra violet rays. It will also guard against mold, mildew and fungus enabling the shelter to stay cleaner between scheduled routine maintenance and when in storage after a deployment. XYTEX 500™ is permanent for the life of the fabric.
The revolutionary Disposcope is an all-in-one wireless video-assisted stylet that combines all the benefits of modern endotracheal intubation technology. It provides all the functionality of a laryngoscope, lighted stylet, video-assisted scope, fiberoptic scope and simple bronchoscope in one lightweight portable device. It is a video-assisted lighted stylet; experienced health care providers can use light and/or video functions to intubate without a laryngoscope. Passing through the vocal chords, the Disposcope serves the same function as a fiberoptic scope. In the trachea, the Disposcope can be used as a simple bronchoscope. www.disposcope.com; Marketed by: Medinostic. B-18, S.I.T.E., Karachi-75700 Pakistan
First Intubating LMA in Pakistan
Muercury Medical’s air-Q has been launched in Pakistan. It is available in disposable as well as reusable versions in a complete range of sizes and comes with tube facilitating stillet. Various studies have confirmed its benefit in ER, OR and ICU settings for intubating patients. Marketed by: Medinostic. B-18, S.I.T.E., Karachi-75700 Pakistan; firstname.lastname@example.org; Phone: +92 21 32573546-49