SonoSite (Bothell, Washington), introduced the S-Nerve procedural tool, which it calls "the first ultrasound device designed to support the specific needs of anesthesiologists who perform regional anesthesia."
The company, which is a global leader in hand-carried ultrasound, said it expects to begin customer shipments of the product in the fourth quarter.
SonoSite said the S-Nerve visualization tool "is built to help regional anesthesiologists perform nerve block procedures in crowded, busy operating environments or anywhere in the hospital."
The company cited the new product's "breakthrough image quality, speed and simplicity," saying it was "designed with input from leading practitioners who expressed a substantive need for a small, high-performance tool, designed to function exclusively as a guidance tool for regional nerve blocks and central line placement."
SonoSite said that, like the S-Fast ultrasound tool it introduced recently for emergency medicine, the S-Nerve device is a new concept in ultrasound.
"The S-Nerve combines excellent image quality with an optimized and targeted user interface for the anesthesiologist," said Christopher Wiley, MD, associate professor of anesthesiology at Dartmouth-Hitchcock Medical Center (Lebanon, New Hampshire). "Anesthesiologists are not ultrasonographers. We care about ultrasound as a means to help us perform regional nerve blocks more accurately, quickly and safely." He added: "The S-Nerve is a major step toward getting the machine out of the way of the image by eliminating lots of knobs and buttons. Its design will make it easier for the novice user to become more expert."
Saying that image-guided regional anesthesia "is in the early stages of a gathering tidal wave of adoption across the globe," Wiley predicted that S-Nerve "will likely accelerate that trend."
SonoSite said adoption of point-of-care visualization "has grown steadily in the practice of regional anesthesiology. A growing body of clinical evidence demonstrates that ultrasound guidance can significantly reduce the time for accurately performing peripheral nerve blocks and placement of catheters."
It added: "Clinicians who have integrated hand-carried ultrasound into their medical practice credit the technology with faster, more accurate needle and catheter placement, confirmation of anesthesia spread, clear visualization of hard to reach or compromised structures, and heightened patient satisfaction."
SonoSite previewed the S-Nerve tool as a work-in-progress at the September congress of the European Society for Regional Anesthesiology in Valencia, Spain.
To create the new visualization tool, the company said it designed a user interface, software and controls that address the procedural needs of the anesthesiologist combined with the same processing power, image quality and data management features of the recently introduced M-Turbo system, which SonoSite said is 16 times more powerful than its industry-standard MicroMaxx system.
That processing power enables the simultaneous deployment of SonoSite's three advanced algorithms, SonoADAPT, SonoHD and SonoMB, to produce major improvements in image quality.
The S-Nerve device is being introduced with what SonoSite termed "an unprecedented combination" of several curved and linear array transducers for virtually every anatomical and clinical anesthesia application.
Elsewhere in the product pipeline:
- AMDL (Tustin, California) has filed with the FDA for clearance for its DR-70 (FDP) ELISA tumor marker test for use as an aid in monitoring patients diagnosed with colorectal cancer. AMDL's DR-70 (FDP) ELISA is an in vitro test for the DR-70 (FDP) antigen in human serum. When cleared to market by the FDA, it will be used as an aid in monitoring the disease status in patients who have been previously diagnosed with colorectal cancer. AMDL believes that the test will be useful as an aid in monitoring cancer patients throughout the course of the disease, including after primary surgery, and in determining the response to therapy. AMDL makes tests for the early detection of cancer.
- Advanced Medical Diagnostics (Waterloo, Belgium) reported that a study published in the British Journal of Urology International showed that its HistoScanning technology has high accuracy in the characterization and localization of prostate cancer foci, according to the company. HistoScanning is a diagnosis support tool designed to detect, visualize and characterize cancers in solid organs. It is used in conjunction with specific commercially available ultrasound systems capable of acquiring and transferring so called volumetric radio frequency data. The tissue characterization algorithms can either be applied to discrete regions of interest or the entire scanned tissue volume. Suspicious areas are highlighted in HistoScanning's 3-D image viewer.
- AFP Imaging (Elmsford, New York) reported receiving FDA clearance to market its NewTom VG cone beam computed tomography scanner. This dental imaging system provides the clinician with 3-D, radiographic images of the teeth and jaws and also features flexible seating options for patient comfort. NewTom VG patients can now stand, sit, or remain in their wheel chairs while being scanned. AFP is a provider of diagnostic imaging for dental, medical and veterinary professionals.
- American Bio Medica (Kinderhook, New York) reported the launch of the Rapid STAT, an oral fluid point-of -collection test combining the incubation benefits of the company's OralStat oral fluid device with its urine-based Rapid TOX cassette product platform. The Rapid STAT also uses the same sample handling procedure of the company's OralStat EX product launched earlier this year. The Rapid STAT provides faster test results, making it ideal for those market applications, such as roadside testing, in which portability and time is crucial. In addition to these added benefits, the Rapid STAT provides even lower THC (marijuana) testing sensitivity. American Bio Medica is a biotechnology company that makes immunoassay diagnostic test kits.
- The American Diabetes Association (Alexandria, Virginia) reported a new web-based diabetes tool that makes it easier for people with diabetes and their care providers to share and organize important health information to improve their diabetes care. The tool, My Diabetes Connector, is a diabetes management software application developed by a software and services company, MyCareTeam (NEEDS location). My Diabetes Connector enables people with diabetes to securely send blood glucose readings from their glucose meter to the My Diabetes Connector Application. It allows input from multiple blood glucose meters. Data stored to My Diabetes Connector is accessible through the Internet, allowing care providers and family members — with the patient's permission — to monitor the information, regardless of location.
- Aperio Technologies (Vista, California) has received FDA clearance for the HER2 image analysis application available through its ScanScope slide scanning system. The immunohistochemistry image analysis application is intended to be used as an aid to pathologists in detecting and quantifying HER2 protein expression from digital slide images created by Aperio's slide scanning systems. Aperio's FDA clearance encompasses the company's complete digital pathology system, including ScanScope scanners for creating digital slide images from microscope slides, the Spectrum digital pathology information management system for managing, viewing, and analyzing digital slides, and the specific image analysis application which performs the automated scoring of IHC HER2 breast cancer digital slides. Aperio Technologies makes digital pathology for the healthcare and life sciences industry.
- Applied NeuroSolutions (Vernon Hills, Illinois) reported that a peer-reviewed paper, "Prediction and longitudinal study of CSF biomarkers in mild cognitive impairment," will be published in an upcoming print edition of Neurobiology of Aging, describing a longitudinal evaluation in the transition from mild cognitive impairment (MCI) to Alzheimer's disease (AD) using five different cerebrospinal fluid (CSF) markers. The APNS P-Tau 231 biomarker was the strongest predictor of the decline from MCI to AD. In this longitudinal study, 86 subjects were followed for two years, including 22 MCI patients that subsequently declined to AD. The APNS P-Tau 231 biomarker was the only biomarker that exceeded the recommended 80% threshold of sensitivity and specificity, with the highest specificity among all biomarkers analyzed in the study in predicting decline from MCI to AD. Applied NeuroSolutions specializes in products for the treatment of Alzheimer's disease.
- Artes Medical (San Diego) reported that treatment has started in 1,000-patient post-marketing study that will follow patients treated with the company's FDA-approved non-resorbable dermal filler, ArteFill, for five years. ArteFill, a non-resorbable injectable dermal filler for the correction of wrinkles known as smile lines or nasolabial folds, is a formulation comprised of polymethylmethacrylate (PMMA), microspheres and bovine collagen, and is the only PMMA-based injectable product that has been approved by the FDA for the treatment of facial wrinkles, according to the company. Artes specializes in the development of aesthetic injectable products.
- AtriCure (West Chester, Ohio) said that results reporting on the company's minimally invasive products, which physicians have adopted to treat atrial fibrillation (AF), were published in the Journal of Cardiovascular Electrophysiology. The authors reported the results from 20 AF patients. Based on the use of 30-day continuous monitoring at one-year follow-up, 87.5% of the paroxysmal and persistent AF patients and 75% of overall patients were free from AF and left atrial arrhythmias and were also off anti-arrhythmic drugs. There were no reports of major complications. AtriCure makes cardiac surgical ablation products.
- Ascent Healthcare Solutions (Phoenix) reported FDA has clearance of two Ascent 510(k) submissions to reprocess specific Medtronic (Minneapolis) and Guidant (Indianapolis) cardiac stabilization and positioner devices. The Medtronic models include the Octopus evolution tissue stabilizer (as well as the other predecessor Octopus models), Starfish and Urchin Heart Positioners. Guidant models covered under this clearance include the complete line of vacuum and mechanical systems: Xpose, Ultima and Acrobat systems. The devices are mainly used in Off-Pump Coronary Artery Bypass (OPCAB) or "beating heart" procedures. About 350,000 U.S. patients undergo coronary bypass grafts annually. Currently, about 25% of the general population cases are being performed off-pump. Ascent Healthcare Solutions is an independent third-party reprocessor of single-use medical devices.
- Avid Radiopharmaceuticals (Philadelphia) reported that enrollment has begun in a proof-of-concept phase I clinical trial investigating Avid's development compound 18F-AV-133 for imaging patients with movement disorders, including Parkinson's Disease, essential tremor and dementias, including Dementia with Lewy Bodies and Alzheimer's disease. The compound, used with PET imaging, targets vesicular monoamine transporters (VMAT2) in the brain and may enable more accurate and earlier diagnosis of neurodegenerative diseases. This new imaging compound may thus lead to improved disease management for patients and their caregivers. Avid Radiopharmaceuticals is a molecular imaging company.
- Baxa (Englewood, Colorado) reported launch of its PadLock set saver, an aseptic IV administration set storage solution that can be swabbed and re-used. PadLock provides a secure seal for the end of the administration set, preventing contamination when the set is not being used for infusion. The set saver attaches to an IV administration set and replaces the need for sterile, single-use caps. The PadLock device is designed to promote best practice for aseptic IV administration set disconnections, preventing touch contamination and securing the IV line in between drug administrations. The set saver also eliminates the use of IV administration set caps, which are a known choking hazard. Baxa specializes in safe handling and packaging of fluid medications.
- Broncus Technologies (Mountain View, California) said that the results of its open-label Exhale drug-eluting stent (DES) feasibility study are published in the October issue of the Journal of Thoracic and Cardiovascular Surgery. Results include a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing for patients at six months after the airway bypass procedure. Airway bypass is a catheter-based bronchoscopic procedure designed to reduce lung hyperinflation and improve breathlessness, by making new pathways for trapped air to exit the lungs. During the minimally invasive procedure, new openings are created in the airway wall connecting the damaged lung tissue to the natural airway. These pathways are supported and kept open by Exhale DES devices. The hope is to improve quality of life by relieving severe symptoms including shortness of breath and hyperinflation of the chest. Broncus Technologies makes products for the treatment of emphysema.
- Cardiac Science (Bothell, Washington) reported the launch of the Quinton Q-Tel RMS 3.0, a cardiac rehabilitation system offering connectivity upgrades and workflow advancements to enable the best possible treatment decisions in cardiac rehabilitation. Some features include: bi-directional connectivity to a hospital's EMR and HIS system; improved tracking of HIPAA compliance requirements through user activity logs; session recovery advancements to prevent the loss of patient data due to power interruption or application error and Q-Tel pocket assistant for wireless session management. Cardiac Science makes cardiac monitoring and defibrillation products.
- Cook Medical (Bloomington, Indiana) has received FDA approval to begin its three-center U.S. Phase I clinical trial designed to evaluate the Cook Zenith dissection endovascular system for the treatment of Type B thoracic aortic dissections. The system is intended for use in the endovascular treatment of descending thoracic aortic dissection in patients with anatomies amenable to endovascular repair. The device's Z-stent exerts a minimal radial force that allows gradual apposition of the dissection septum and re-expansion of the true lumen. Endovascular aortic repair (EVAR) eliminates the need for highly invasive open surgery. The stent-graft expands upon deployment from the catheter to form a continuous tube through the aorta that carries the blood and reduces pressure on the damaged vessel, restoring normal blood flow. The uncovered Zenith Dissection Stent may be used to expand the true lumen in the distal thoracic aorta where preservation of the side branch artery blood flow is critical. Cook Medical makes interventional devices.
- DePuy Mitek (Raynham, Massachusetts) reported the launch of the ExpressEW II flexible suture passer, a minimally invasive device that saves time and increases operating room efficiency during arthroscopic rotator cuff surgery. The prodcut has a 4.5mm profile, which allows for greater efficiency and precision through a smaller incision site or cannula and provides mobility and function in tight anatomy. Its jaw design provides > 16 mm tissue bite offering flexibility in suturing both medial and lateral rows during rotator cuff repair. Active people, including athletes, are susceptible to rotator cuff problems, particularly as they get older. Doctors perform surgery to reattach the rotator cuff to the humerus, the bone in the shoulder, to relieve pain and increase strength and mobility. DePuy makes surgical sports medicine devices.
- Draeger Medical (Telford, Pennsylvania) reported the release of the Fabius Tiro M, a deployable field anesthesia machine designed for use in a variety of environments in support of military missions worldwide. Fabius Tiro M is designed to provide a full-featured anesthesia machine in a compact system for military installations in the field where general anesthesia is required. Developed in concert with military field hospital experts, the Fabius Tiro M incorporates an electronically-controlled, piston-driven ventilator equipped with several advanced ventilation modes. The ventilator's piston technology eliminates the need for a compressed gas source to drive the ventilator, which is an important consideration in field environments. Draegerwerk makes medical and safety technology.
- Enova Medical Technologies (St. Paul, Minnesota) said that it has developed new LED technology for cordless surgical headlights that reaches light output levels exceeding 200,000 lux at 14 inches. This provides light intensity that is comparable to most 300-watt fiber optic xenon headlight systems that are commonly used by "deep cavity" surgeons, such as cardio, colo-rectal, neuro, orthopedic, thoracic, and vascular surgeons. Enova will use its new lighting technology in the IRIS 2X cordless surgical headlight, a new product being designed specifically for deep cavity surgeons.
- FzioMed (San Luis Obispo, California) said that the FDA has completed its initial review of the company's PMA application for Oxiplex spine surgery gel and has accepted the PMA for filing. FDA also confirmed that the Oxiplex PMA will receive expedited processing. Oxiplex is intended to reduce pain and symptoms following lumbar spine surgery. Oxiplex is an absorbable gel used during lumbar laminectomy, laminotomy and discectomy surgical procedures. Oxiplex gel is applied around the sensitive spinal nerve root and surrounding neural tissues, creating a protective environment during post-surgical healing. Oxiplex does not interfere with normal healing and clears naturally from the body. FzioMed makes absorbable, surgical biomaterials.
- HemoBioTech (Dallas) said it has gathered results from a pre-clinical study of its HemoTech blood substitute product in patients undergoing percutaneous coronary intervention (PCI) through angioplasty and stent implantation, the most common PCI procedures. In the ex vivo human study, HemoTech showed markedly reduced platelet aggregation, one of the major complications associated with PCI procedures. HemoTech also demonstrated the potential for preventing restenosis, another potentially dangerous side effect of PCI. HemoTech is composed of bovine hemoglobin that is chemically modified with adenosine triphosphate, adenosine, and glutathione. In addition to carrying oxygen through the bloodstream, HemoTech also induces erythropoiesis (red blood cell production). Based on preclinical studies and an initial foreign human clinical study, the company says that HemoTech, due to its unique chemical composition, may diminish or even eliminate the toxicities that have plagued other attempts at developing blood substitutes.
- Hillenbrand Industries (Batesville, Indiana) reported that its Hill-Rom subsidiary has introduced a new hospital bed surface that it believes can enhance care for patients with pressure ulcers. The Hill-Rom E700 Wound Surface (a low air loss therapy surface) also offers new levels of flexibility for use within healthcare facilities. Unlike traditional mattress replacement systems, this surface easily converts to fit multiple bed frames, including Hill-Rom frames and a variety of other frames, the company said. E700 Wound Surface features pressureSmart sensing technology that senses the patient in real time and automatically adjusts to provide optimal pressure redistribution as the patient sleeps, turns, sits up and gets in and out of bed.
- Immersion (San Jose, California) reported that Immersion Medical subsidiary has introduced the OB/GYN surgical simulation module, the LaparoscopyVR (LapVR) surgical simulator. LapVR provides training for ectopic surgical intervention, tubal occlusion, and salpingo-oophorectomy (fallopian tube and ovary removal) and is designed as a complete system with integrated TouchSense haptic hardware and software. The system provides a physics-based environment that allows realistic graphical movement of tissue and organs integrated with realistic tactile feedback forces felt through the trocar arms and handles. The system comes with widely viewable monitor suitable for team training; virtual camera; tools; and administration, essential skills, adhesiolysis, and lap chole (gall bladder removal) modules packaged in an ergonomic, height-adjustable, wheeled cart.
- InstrumentationLaboratory (Lexington, Massachusetts) received FDA clearance to expand use of its HemosIL D-Dimer HS to exclude venous thromboembolism (VTE) in outpatients suspected of deep vein thrombosis (DVT) and pulmonary embolism (PE), when used in conjunction with a clinical pretest probability assessment model. HemosIL D-Dimer HS features expanded working range, high analytical sensitivity, virtually no interference from rheumatoid factor and minimal optical interference from hemoglobin, lipemia and bilirubin. It is automated on the ACL TOP system with time to results in less than five minutes. Instrumentation Laboratory makes in vitro diagnostic instruments.
- IntraOp Medical (Sunnyvale, California) reported the introduction of the optimal boost approach to breast cancer treatment administered by its product, Mobetron. The optimal boost approach was used in a recent study of 378 patients in Europe and significantly reduced breast cancer recurrence rates. Mobetron is a portable, self-shielding electron-beam linear accelerator that delivers radiation therapy in the operating room at the time of cancer surgery. Mobetron administers intraoperative electron-beam radiation therapy directly to the tumor bed once a cancerous growth has been excised during surgery. The Optimal Boost method, or as it is commonly referred to in breast cancer treatment, the bio-boost method, consists of applying a high dosage of radiation to the tumor bed at the time of lumpectomy followed by traditional post-operative radiation therapy. IntraOp Medical makes products for the treatment and eradication of cancer.
- Ingen Technologies (Nyucaipa, California) said that OxyAlert is expected to receive an "exempt" status from the 510(k) filing in 60 days. OxyAlert is a new medical technology that uses wireless communication to send information related to the status of an oxygen delivery system to a remote receiver. Using a special microchip referred to as ZigBy, OxyAlert complies with the medical standards for wireless communication, and at the same time provides patients and caregivers the ability to distance themselves from the oxygen delivery system and still monitor the amount of oxygen being delivered.
- Introgen Therapeutics (Dallas) reported the results of new data analysis from multiple Phase II clinical studies showing a statistically significant correlation between the abnormal p53 biomarker and tumor response after treatment with Advexin in patients with head and neck, lung, prostate and Li-Fraumeni Syndrome cancers. In 54 late-stage cancer patient samples evaluated from the studies, tumor response after Advexin monotherapy was observed in 35% of patients with the abnormal p53 biomarker and all tumor responses occurred in the abnormal p53 biomarker group. The majority of these patients had recurrent disease after receiving standard therapies. Advexin p53 therapy is a targeted molecular therapy with broad applicability in a wide range of tumor types and clinical settings because it targets one of the most fundamental and common molecular defects, abnormal p53 tumor suppressor function, associated with cancer initiation, progression and treatment resistance. Introgen Therapeutics makes targeted tumor suppressors.
- K2M (Leesburg, Virginia) reported the Phase II launch of its Pyrenees cervical plate system. Pyrenees' low profile features a 1.5 mm leading edge which potentially minimizes patient discomfort, particularly esophageal irritation. In addition, this system has low profile drill guides, allowing for optimal viewing of the bone graft window. The "tifix" locking technology requires no additional locking mechanism, whereby each screw head forms an autogenic, or self-producing, lock to the plate. With screw flexibility of up to 45 conical degrees and a corresponding low torque driver, Pyrenees also combines the benefits of multidirectional screw placement with a rigid plate. K2M makes products for spinal pathologies and procedures.
- McKesson (Atlanta) reported the release of Horizon Homecare Wound Advisor, a disease management solution for centralized and in-home care. Wound Advisor assists in evaluating the wound status of patients — decline, new referral or existing referral — providing "one-click" access to patient histories, assessment findings and digital wound images from a central location. In addition to centralized care, Horizon Advisor assists clinicians at the point of care with a standardized wound assessment, wound image(s) and pertinent patient information including education, supply use and treatment protocols. McKesson is a healthcare services and information technology company.
- MDS Analytical Technologies (Sunnyvale, California) reported release of the MetaMorph ICS (integrated confocal system), in partnership with VisiTech International (Sunderland, UK), a manufacturer of confocal hardware. This turnkey, confocal microscope is the first of its kind in the imaging industry. It has the capability to obtain high-resolution images in multiple dimensions to support researchers in their exploration of live cell and functional imaging without the limitations inherent in other high-speed imaging technologies. This microscope combines the Molecular Devices' MetaMorph software with the VT-Infinity 2D-array laser confocal scanner from VisiTech International. This combination is designed to meet the growing demand for imaging rapid changes within cells and then analyzing these changes in multiple dimensions. MDS makes diagnostics and other life science products.
- MedicalAcoustics (Buffalo, New York) reported the initial commercial shipments of its pulmonary device, the Lung Flute, a small, flute-shaped plastic device designed to assist in the harvesting of sputum for diagnostic purposes. It generates a specific low frequency sound when the user blows into it and the resulting sound waves vibrate the airways and lung secretions, causing the deep lung secretions to thin and be expelled. The Lung Flute enables pharmaceutical developers to monitor inflammatory biomarkers during an asthma attack or at various stages of obstructive or restrictive pulmonary events. Medical Acoustics makes employs acoustic technologies for diagnostic and therapeutic medical applications.
- Microlife USA (Dunedin, Florida) reported launch of the Microlife blood pressure monitoring and Peak Flow/FEV1 monitoring drivers as a part of its newly launched consumer health platform, Microsoft HealthVault, to provide consumers with a new way to manage their health at home. The online environment allows consumers to search and connect people with their stored health information, putting them in greater control of their health and wellness. Microlife's contribution includes the manufacture and support of clinically validated, hospital accurate blood pressure monitors and digital electronic Peak Flow/FEV1 meters. The Microlife application allows patients to upload the stored measurement readings from their compatible Microlife blood pressure monitor to the HealthVault site where they can be reviewed by their physician or other authorized healthcare provider. Microlife makes medical diagnostic equipment for home and institutional use, with a focus on blood pressure monitors, digital and infrared thermometers and peak flow meters.
- Nanosphere (Orthbrook, Illinois) said that it has received clearance from the FDA for the Verigene F5/F2/MTHFR nucleic acid test, which detects gene mutations that can contribute to blood coagulation disorders and difficulties metabolizing folate (vitamin B-12). This marks the second nanotechnology-based assay cleared by the FDA to run on the Verigene system, following clearance in september of the company's Verigene warfarin metabolism nucleic acid test. The test is the first FDA-cleared test for the identification of mutations in three specific genes that together can increase an individual's risk for dangerous blood clots and their leading complication, stroke. The test is available in single and multi target (multiplex) formats, allowing users to select the test cartridge that best fits the clinical indications for testing. Nanosphere is a nanotechnology-based molecular diagnostics company.
- Northstar Neuroscience (Seattle) said that the last patient in the company's EVEREST trial for stroke motor recovery completed four week follow-up, the primary endpoint for the trial. EVEREST is a national, multi-center, single-blinded, randomized clinical trial investigating whether Northstar's Renova-ST cortical stimulation system in conjunction with physical rehabilitation improves hand and arm function in stroke survivors compared to those receiving physical rehabilitation alone. The trial is being conducted at 21 stroke centers throughout the U.S. and when complete will include data from more than 150 subjects. Northstar is focused on developing neurostimulation therapies to treat neurological injury, disorder and disease.
- Novadaq Technologies (Toronto) launched the PINPOINT endoscopic imaging system at the Annual Meeting of American College of Chest Physicians (), CHEST 2007. PINPOINT is based upon the endoscopic technology Novadaq acquired from Xillix Technologies, and is designed to not only perform white light bronchoscopy, but also the more clinically relevant imaging commonly referred to as autofluorescence and narrow band imaging. Many studies have shown autofluorescence to be more effective in the detection and localization of central airway cancers than conventional white light bronchoscopy. Novadaq makes medical imaging systems.
- OBS Medical (Indianapolis) reported clearance to market Visensia, its next generation patient deterioration early warning system in the U.S. Formerly known as BioSign, the Visensia technology evaluates up to five vital signs — heart rate, respiration rate, body temperature, oxygen saturation and blood pressure — and fuses this data into a single measurable index, the Visensia index. The Visensia enables hospital clinical staff to evaluate patient deterioration from central locations (department central station or hospital-wide patient safety response center). In addition, the system will integrate vital signs from periodic monitoring environments (such as medical/surgical floors and telemetry floors) to create a hospital-wide patient deterioration early warning system.
- Omnicell (Mountain View, California) introduced the Omnicell WorkflowRx 5.0 central pharmacy automation solution, allowing pharmacy staff to complete automated dispensing, unit-dose packaging and other inventory maintenance tasks simultaneously. The WorkflowRx 5.0 solution interfaces to Omnicell's barcode packaging system and inventory management carousel system to manage 100% of the central pharmacy inventory and dispensing tasks. Omnicell provides system solutions to acute healthcare facilities for improving patient safety and operational efficiency.
- OmniGuide (Cambridge, Massachusetts) reported launch of its LightPath fiber for use in minimally-invasive surgical procedures. The fiber features a fine spot size down to 200 microns enabling surgeons to safely conduct more precise procedures in laryngology, head & neck surgery, neurotology, and skull base surgery. The LightPath product uses OmniGuide's "photonic bandgap" technology exclusive to all OmniGuide fibers. OmniGuide makes flexible CO2 laser fibers for precision surgery.
- Paramed (Salt Lake City) reported release of its Mobility Offers Versatility (MOV) chair, a motorized stair-chair capable of carrying fire, emergency medical, and rehabilitating patients both up and down flights of stairs with the touch of a button. The MOV has been designed to significantly reduce the inherent risk of back and lower abdominal injury for the caregiver when transporting a non-ambulatory patient up or down stairs. Paramed makes patient transport devices for non-ambulatory patients.
- PEAK Surgical (Palo Alto, California) reported results from a preclinical study evaluating its PEAK pulsed plasma technology in the healing of surgical incisions compared with standard electrosurgery and surgical scalpels. Results showed that the PEAK PlasmaBlade, which uses pulsed plasma energy to create surgical incisions, efficiently cut tissue with minimal bleeding, tissue injury and scarring. PEAK surgical's flagship surgical system, the Pulsar surgery system, combines the pulsar generator, which provides unique pulsed plasma radiofrequency waveforms, with the PEAK PlasmaBlade, a highly insulated tissue dissection instrument, to enable precise cutting with bleeding control and minimal thermal damage. This technology provides the benefits of both traditional scalpel and electrosurgery approaches -- enabling surgeons to cut soft tissue precisely with little damage to surrounding tissues and to control bleeding. PEAK Surgical makes radiofrequency tissue dissection instrumentation.
- PerkinElmer (Waltham, Massachusetts) unveiled an analytical solution for the determination of melamine adulteration in protein-based foods. With the release of the Melamine Analyzer, based on the Clarus 600 T Gas Chromatograph/Mass Spectrometer (GC/MS), PerkinElmer said it is the first in the industry to provide such a solution using GC/MS technology. The Melamine Analyzer includes the instrumentation, consumables and applications resources needed to screen for melamine contamination, conforming with the most recent guideline from the FDA. Melamine is a nitrogen-rich industrial chemical that became well-known in North America recently after its presence in wheat gluten was linked with renal failure in dogs and cats. PerkinElmer specializes in the health sciences and photonics markets.
- Physio-Control (Seattle) reported that the Lucas chest compression system is available in the U.S. through a distribution partnership with Jolife AB (Lund, Sweden). The Lucas Chest Compression System is an external medical device that provides chest compressions during CPR. Lucas runs on high-pressure air supplied either by a compressed air tank or the air wall outlet in a hospital. Designed for both out-of-hospital and in-hospital use, Lucas is indicated for treatment of adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, as well as loss of consciousness. The system enables hands-free compressions, provides sustained circulation during patient transport in both out-of-hospital and in-hospital situations, makes CPR possible from the field to the hospital and reduces the impact of extenuating circumstances on the interruption and quality of chest compressions, such as transport conditions, and secures the patient's arms before transport and enabling rescuers to sit, wearing seatbelts during transport, rather than standing to provide compressions in a moving vehicle. Physio-Control is a subsidiary of Medtronic (Minneapolis).
- Signalife (Los Angeles) said that is has completed in-house testing and technological evaluation of new modules for its holter and intra-cardiac monitors — items that have previously been an important part of the company's business plans and are now ready for submission to FDA for clearance. Both of these developments are ahead of schedule, and are of importance because they are both revenue producing as well as scientifically significant to the reduction of the $400 billion in cardiovascular expenses as well as to patient health and welfare. Signalife specializes in biomedical monitoring.
- Small Bone Innovations (SBI; New York) introduced its Precise SD volar distal radius locking plate system to augment its wrist management portfolio. The plate geometry is based on computer analysis of CT data generated from a broad series of distal radii in the Hamann Todd Osteological Collection at the Cleveland Museum of Natural History. The result is an anatomic locking plate that provides optimized fit and improved articular support over a broad range of anatomic variations. The plate's poly axial locking screw technology is a patented, low profile design with a proven clinical track record. SBI makes products for the small bone and joint sector.
- Smith & Nephew's Endoscopy Division (Andover, Massachusetts) reported the launch of the Kinsa RC 5.5 auture anchor, designed to provide secure repair of shoulder injuries stemming from tears to the rotator cuff, the group of muscles and tendons that control shoulder motion. Surgeons can repair these injuries using arthroscopic -- or minimally invasive — techniques with specialized instruments and devices such as the KINSA RC Suture Anchor, which re-attaches the torn tissue to restore mobility. The product is the second in Smith & Nephew Endoscopy's line of Kinsa suture anchors. The original Kinsa anchor, for treatment of shoulder instability, was released in 2006. Both Kinsa anchors encase a sliding, self-locking knot that permits the surgeon to secure the repair without tying knots on top of the tissue. Surgical knots in arthroscopic repairs can sometimes loosen or cause irritation of surrounding tissue. The Kinsa RC anchor instead delivers "low profile" repair, without knots or protrusions to interfere with the joint motion.
- SonoSite (Bothell, Washington) reported the introduction of the M-Turbo ultrasound system for use in the full range of clinical applications at the point of care. The system delivers an increase in processing power for superior image clarity across all exam types, plus connectivity for digital image export in a rugged, hand-carried product weighing less than eight pounds. SonoSite said it plans to begin deliveries later this quarter. SonoSite says that the M-Turbo system offers a 16-fold increase in processing power yet weighs slightly less than the MicroMaxx system. The system's increased processing power generates dramatic improvements in image quality by simultaneously running multiple advanced algorithms: SonoADAPT Tissue Optimization, automatically adjusts imaging parameters depending on exam type and patient size based on imaging depth, thereby eliminating complicated clinician manipulation of multiple controls. SonoHD Imaging Technology - leverages the exponentially increased processing power to reduce speckle noise and other image artifacts while preserving and sharpening tissue information and enhancing the aesthetic and clinical value of the image; SonoMB Multi-beam Imaging, further enhanced and now available on all M-Turbo transducers, including the phased array transducer to facilitate cardiac and abdominal examinations, SonoMB technology was first introduced in April 2007 as a software upgrade for the MicroMaxx system.
- Starion Instruments (Sunnyvale, California) reported the launch of the TLS3 tissue ligating shears. With the introduction of this new platform, Starion said it is building upon its success in the cardiovascular and otolaryngological markets to provide an essential solution for general surgical, gynecological and urological procedures. The TLS3 features Starion's tissue welding technology, which focuses thermal energy to simultaneously seal and divide soft tissue, designed to reduce thermal spread, which minimizes the risk of inadvertent collateral damage. The TLS3 features enhanced sealing and dissecting capabilities, an ergonomic handle design, longer, more tapered jaws, and two-speed finger control for improved open and minimally invasive surgical procedures. Three lengths, 14 cm, 23 cm and 35 cm, provide improved sealing and dividing of larger vessels frequently encountered in general surgical, gynecological and urological procedures. Starion is a surgical device company.
- Stereotaxis (St. Louis) said a presentation by Xu Chen, MD, of the Rigshospitalet at the University of Copenhagen, showed a 93% acute success rate in patients treated for atrial fibrillation with the Niobe magnetic navigation system. Chen's presentation focused on his use of catheter ablation to treat 42 patients with atrial fibrillation. In all cases, Chen guided the catheters with the Niobe magnetic navigation system, controlled from his remote station adjacent to the procedure room. In 93% of these cases the pulmonary veins were fully isolated from the left atrium, eliminating the main cause of the arrhythmia. Stereotaxis makes cardiology instrument control systems for use in a hospital's interventional surgical suite.
- Stinger Medical (Murfreesboro, Tennessee) has introduced a continuous-power, mobile, point-of-care system, the Mobius Power, calling it the only continuous power system for mobile workstations that allows clinicians to exchange power modules as needed without interrupting workflow. The system comes with a lightweight battery pack weighing 3.3 lbs and a compact charging device, allowing the system to run 24/7. Stinger makes mobile clinical workstations and point-of-care technologies for the healthcare marketplace.
- TeleTracking's (Pittsburgh) BedTracking mobile, a bed tracking tool for handhelds, was during the 2007 Annual ASHES Conference and Marketplace in St. Louis. BedTracking mobile transfers BedTracking to a PDA so environmental services supervisors can avert patient flow problems and speed bed turnover from anywhere in the hospital. The wireless version provides real-time bed status, including pending transfers and discharges. Users communicate directly with staff via 'taps' on the PDA screen. Other features include alerts when bed cleaning requests are delayed, re-assigning tasks on the fly, and much more. It is one of several wireless patient flow solutions either in service or soon to be available as part of TeleTracking Technologies' expanding mobile strategy, which is based on the recognition that to avert patient flow problems, supervisors sometimes need to be on the move instead of at a desktop PC. TeleTracking makes automated solutions to relieve hospital overcrowding, provides software and process redesign services that make real-time patient flow management possible.
- ThermoGenesis (Rancho Cordova, California) said that it has received FDA clearance for its AXP AutoXpress platform (AXP), an automated system that isolates and captures stem cells from umbilical cord blood in a closed system. The clearance covers the complete AXP platform, including the AXP hardware device, docking station, disposable bag processing set, overwrap bag and XpressTRAK software that assists with quality assurance and compliance with current good manufacturing practices (cGMP) and current good tissue practices (cGTP). The AXP is a proprietary and patented automated device and companion sterile closed blood processing disposable used to harvest stem cells from cord blood. ThermoGenesis makes products that harvest, process, store, and administer therapeutic doses of adult stem cells for treatment of disease and injury
- Transoma Medical (St. Paul, Minnesota) said that it has received FDA clearance for its Sleuth electrocardiogram monitoring system, the first wireless, implantable heart monitor for human applications. Sleuth monitors heart activity to provide accurate, timely diagnostic data for evaluating cardiac arrhythmias and other serious conditions, which often lead to infrequent, unexplained syncope (fainting). The sleuth includes a high-definition implantable loop recorder, a personal diagnostic manager, and a monitoring center. Transoma makes implantable wireless monitoring systems for biomedical research.
- Verathon (Bothell, Washington) reported the introduction of the GlideScope ranger single use video laryngoscope that provides a clear, real-time view of the airway and endotracheal tube placement, enabling quick intubation. Specifically for use in the Emergency Department (ED), EMS and military applications, the GlideScope design, which eliminates the need for disinfecting the "blade," is ideal for fast-paced intubation settings. The GlideScope consists of: a slim video baton which houses a high-resolution camera with a patented anti-fogging mechanism to resist lens contamination; a non-glare color monitor that is easily seen in bright light; and single-use, sterile GVL(R) Stats in large and small sizes that offer a 60-degree blade angulation.
- W. L. Gore & Associates (Gore; Flagstaff, Arizona) reported FDA approval for its Gore Helex septal occluder with modified catheter delivery system indicated for the transcatheter closure of atrial septal defect (ASD). The Helex is a permanently implanted prosthesis and the first device of its kind to use ePTFE, a biocompatible material that allows tissue ingrowth, to seal the defect. The catheter-based delivery system allows for easier device deployment via standard femoral venous access. The Helex is composed of ePTFE patch material supported by a single nitinol wire frame that bridges and eventually occludes the septal defect to stop the shunting of blood between the atria. Over the course of several weeks to months, cells begin to infiltrate and grow over the ePTFE membrane, resulting in successful closure of the defect. The Gore medical products division includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery.