BB&T Senior Staff Writer And Staff Reports

Doctors who want to monitor their patient's ECG and blood pressure for a 24-hour period now have an alternative option to asking their patient to wear two separate monitoring devices to record the data – Vasomedical (Westbury, New York), said it recently received FDA clearance for a device designed to do both.

The company this week reported receiving FDA 510(k) clearance to market its Vasomedical-BIOX Model 2301 Combined ECG Holter and ambulatory blood pressure monitoring recorder and software analysis system. The company received FDA clearance for its Vasomedical BIOX Model 1305 Holter monitor and anaylsis software this time last year.

Traditionally, devices that record ECG signals and devices that monitor blood pressure are separate systems, Jun Ma, PhD, president/CEO of Vasomedical, said.

Ma explained that under certain conditions, doctors sometimes prescribe both devices for the patients to wear for a 24-hour period.

“Our combined two-in-one device eliminates the need of carrying two devices, so it becomes compact and a lot more comfortable to wear,“ Ma said. He added that a second benefit of the system is that the interaction of the two signals allows the system to measure the patient's blood pressure signal at the same time as they experience certain cardiac abnormalities, which provides added diagnostic value, he said.

“These are the first in a line of Vasomedical-BIOX ECG Holter and ambulatory blood pressure monitoring systems that Vasomedical intends to bring to the marketplace,“ Ma said. “The introduction of Model 1305 Holter Monitor last year placed Vasomedical into the patient monitoring business with a high quality digital equipment that has enjoyed international success. The Model 2301, however, will make Vasomedical a supplier of ambulatory equipment, because it is so far the only combined ambulatory ECG/blood pressure recording device in the United States. In addition to being a compact device that replaces two separate recorders, it also provides interactive blood pressure recording at times of certain cardiac abnormalities, thus significantly enhancing the diagnostic value of the recorded data while increasing patient comfort and ease of use.“

Ma said the company plans to add a few more ECG devices to the product line in the future.

According to Derek Enlander, MD, a New York City internal medicine physician, the Vasomedical BIOX 2301 is the only personal combined system to simultaneously and continously record and store ECG and blood pressure data for 24 hours. “The ability to view these parameters simultaneously, side by side is unique,“ Enlander said. “It gives the physician more useful information to evaluate the patient's cardiovascular status and make appropriate clinical judgment.“

Enlander noted that for the past few years, Holter monitors and other ambulatory devices have increased in use, allowing early diagnosis and disease management not only by cardiologists but by general practitioners. “I believe this product will have a great impact on the improvement of healthcare quality and reduction of healthcare cost,“ he said.

Vasomedical primarily makes enhanced external counterpulsion (EECP) systems based on its proprietary technology. According to the company, EECP therapy is a non-invasive, outpatient therapy for the treatment of diseases of the cardiovascular system currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and congestive heart failure. The therapy serves to increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function, the company said. Vasomedical received a U.S. patent for the technology three years ago.

BIOX Instruments (Jiangsu, China), is a strategic partner of Vasomedical. BIOX makes electrical medical instruments. Its core products include Holter recorders, ambulatory blood pressure monitors and comprehensive analysis software.

Elsewhere in the product line:

• AdvanDx (Woburn, Massachusetts/Vedbaek, Denmark) said it has received 510(k) clearance for a fast, 90 minutes protocol for its C. albicans PNA FISH and C. albicans/C. glabrata PNA FISH tests. The faster protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes, AdvanDx said. Clinical validation studies performed at hospitals in the U.S. demonstrated 100% agreement between the 90 minutes protocol, the original PNA FISH protocol and conventional identification methods, ensuring the faster protocol maintains the very high sensitivity and specificity required versus slower, conventional methods, the company noted. According to AdvanDx, Candidemia, a bloodstream infection caused by Candida species, is one of the most serious hospital acquired infections, afflicting more than 24,000 patients in the U.S. every year. Immunocompromised transplantation, oncology and AIDS patients are especially at risk for contracting the infection with mortality rates as high as 50%, the company said.

• BD Diagnostics (Baltimore), a segment of BD (Becton, Dickinson and Company), reported the addition of the BD Innova Preanalytical Automated Microbiology Specimen Processor, which is designed to help increase laboratory efficiency and automate the modern microbiology laboratory. By acquiring the Lab Systems division of Dynacon, a privately held corporation based in Ontario, BD said it adds innovative product platforms from a leader in preanalytical microbiology automation. These product platforms include the InocuLAB and Innova platforms.

• Chronix Biomedical (San Jose, California) reported publication of a study that supports the use of its serum DNA blood tests to predict clinical status and monitor disease activity and response to treatment in multiple sclerosis (MS). Chronix uses proprietary technology to identify disease-specific genetic fingerprints based on the circulating DNA that is released into the bloodstream by damaged and dying cells. Chronix claims publications and other researchers shows that this circulating DNA can be identified and analyzed to provide a diagnostic window into ongoing changes in the genome associated with specific diseases – changes that can be used to track the presence or absence of active disease. This new study is the first to show that the Chronix approach can be used to monitor the clinical status of a chronic disease. The findings are published in the current online edition of the Journal of Molecular Diagnostics.

• ConvaTec (Skillman, New Jersey) reported the launch of Aquacel Ag surgical cover dressings for the post-operative care of surgical incisions. ConvaTec says its patented hydrofiber technology is combined with skin-friendly hydrocolloid technology. The Aquacel Ag surgical cover dressings are supported by evidence showing significant reduction in the incidence of superficial surgical site infection (SSI), skin blistering and delayed discharge as compared to a non-woven post-operative surgical cover dressing regimen. “The innovative design of Aquacel Ag Surgical cover dressings has been proven to handle post-operative challenges – complications that can translate to increased time, expense and concern for the patient's well-being,“ said Michael Steadman, president of ConvaTec Wound Therapeutics.

• DFine (San Jose, California) said it has launched a new access system for the RF Kyphoplasty procedure using the StabiliT Vertebral Augmentation System. DFine claims the RF Kyphoplasty procedure with the StabiliT system provides physicians greater control in the treatment of vertebral compression fractures through site and size specific cavity creation and an ultra high viscosity bone cement over an extended working time using a remotely controlled delivery system to stabilize the fracture, relieve pain and improve patient quality of life.

• As part of its I.V. Room of the Future initiative to cooperate with other industry leaders, Health Robotics (Bozen, Italy) reported the availability of its Virtual High-Availability Architecture, including virtualization compliant, cluster and fail-over, disaster recovery, and back-up solutions for its CytoCare and i.v.STATION robots (with future expansion to TPNstation when available), and its i.v.SOFT Workflow Engine for manual compounding. Health Robotics' core technology can be deployed on multiple configurations, ranging from one active node and a stand-by node, to active/passive clustered nodes with a remote disaster-recovery stand-by node. Virtualization is an irreversible process already initiated by many of the top-rated medical centers around the world, and it should be much more so when it comes to life-critical I.V. Admixtures. Health Robotics said it decided to engineer this concept as an additional option for customers and therefore safeguard their investments in I.V. automation, providing full support for the implementation of our core technology on all major virtual environments.

• IZI Medical Products (Baltimore) has introduced two new lines of flat mammography markers, which are being made in the U.S. and sold worldwide under the brand of Mammography Indicator Markers. The new markers, available in radiolucent and radiopaque varieties, function as reference points used by mammography technologists to accurately and reliably indicate an area of interest on the breast (e.g. masses, scar tissue, moles, etc.) in diagnostic mammograms.

• Medtronic (Minneapolis) reported the launch of a new Frontal Handpiece for its Hydrodebrider System, made by the company's Ear Nose and Throat division. The Hydrodebrider System is a powered endoscopic irrigation system for removing bacteria from the paranasal sinuses. It is used for the treatment of chronic sinusitis. The new frontal handpiece has a 2.2 mm diameter with fixed 80° articulation for access to the hard-to-reach frontal sinuses. Surgeons can connect the Hydrodebrider console to the Frontal Handpiece, the Standard Handpiece for maxillary, ethmoid and sphenoid sinuses, or both. Each handpiece delivers a rotating spray of pressurized saline at 5 mL/sec, enabling access for direct irrigation of sinus mucosal surfaces. In vitro research has demonstrated a 99% reduction in bacterial coverage in chronic sinusitis specimens treated with the Hydrodebrider System.

• Nextrials (San Ramon, California) said that the latest version of its Prism electronic data capture and clinical trial data management platform will now support anytime/anywhere data access via the Apple iPad slate computer. Because Prism 3.0 is fully integrated with platforms traditionally used for electronic health records within the healthcare setting, its compatibility with the iPad enables physicians, researchers and others to have real-time access to data regardless of locale, and delivers that data in the familiar graphical formats traditionally generated by Prism on a desktop computer, Nextrials said. The company notes that the iPad has the potential of meeting many specific healthcare needs, such as serving as a handheld terminal for physician-led grand rounds, the examination of X-rays at remote locations and histology reviews. In the clinical trial setting, it can give researchers instant access to adverse event data, patient recruitment status, supply availability and other critical real-time data.

• Sysmex America (Mundelein, Illinois) said that its Sysmex XT-4000i Automated Hematology Analyzer has received FDA clearance. The Sysmex XT-4000i provides 34 parameters, including the advanced clinical parameters, IG (Immature Granulocyte) and RET-He (Reticulocyte Hemoglobin Equivalent) and a Body Fluid specific mode. It uses Sysmex's fluorescent flow cytometry and advanced cell counting methods to deliver rapid, reliable results essential in patient diagnosis and therapeutic monitoring. The company claims that the Sysmex XT-4000i automated hematology analyzer's IG parameter provides the reliable detection and quantification of circulating immature granulocytes that may be used by physicians as an early indicator of acute infection, inflammatory response or myeloproliferative disorder. Its RET-He parameter, which quantifies the hemoglobin content of reticulocytes, is an established parameter in the National Kidney Foundation's KDOQI (Kidney Disease Outcomes Quality Initiative) guidelines for assessing the initial iron status of patients with chronic kidney disease on hemodialysis as well as I.V. iron replacement in these patients.

• TomoTherapy (Madison, Wisconsin) cited results of a study that showed the benefits of TomoTherapy technology in a variety of cases requiring craniospinal irradiation (CSI) in children and young adults. The study concluded that the TomoTherapy platform offers a major dosimetric advantage in treating both standard and complicated cases by using integrated daily imaging and helical radiation delivery to more accurately target tumors and spare surrounding structures and organs. As reported in the study, “Helical TomoTherapy delivers continuous arc-based [intensity-modulated radiation therapy] (IMRT) that gives high conformality and excellent dose homogeneity for the target volume. Helical TomoTherapy allows for differential dosing of multiple targets resulting in very elegant dose distributions. By its conformal nature, IMRT is very sensitive to improper patient setup. The use of pretreatment [megavoltage CT] (MVCT) imaging with [helical TomoTherapy] allows for increased precision with respect to patient positioning and use of a reduced [planning target volume] (PTV) margin.“

• Unilife (Lewisberry, Pennsylvania) has received FDA clearance for the Unitract 1 mL Insulin Syringes. The company says the Unitract range of 1mL syringes is the world's first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse.