Molecular diagnostics manufacturer Cepheid (Sunnyvale, California) reported receiving FDA clearance for its Xpert MRSA test, which runs on the GeneXpert System, for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA). Xpert MRSA results, designed to be delivered in just over one hour, are expected to rapidly identify carriers of the potential pathogen and enable healthcare organizations to implement the proper infection control measures, which is expected to lead to lower hospital acquired infection rates while improving patient care, the company said.
According to Cepheid, MRSA is a growing public health concern, and it is cited as the leading cause of hospital-acquired infections (HAI’s).
“Currently there are multiple initiatives directed at reducing HAI’s, especially those caused by MRSA,” said John Bishop, CEO of Cepheid. “The GeneXpert platform is uniquely positioned to aid hospitals currently doing molecular testing and hospitals considering initiating molecular testing. An additional benefit will be the ability of the GeneXpert system to provide reliable on-demand test information on a 24/7 basis. We expect to see the Xpert MRSA test play a critical role in active surveillance programs nationwide.”
According to the Centers for Disease Control and Prevention (Atlanta), HAI’s number more than 2 million annually, and more than 100,000 hospital patients die each year as a result of contracting an infection while being treated for another condition. And Cepheid cited a U.S. Congressional Record report saying that HAI’s contribute to more than $50 billion in annual medical costs. MRSA infection rates have increased every year since 1970.
Cepheid said it is engaged with a “broad cross-section” of healthcare organizations interested in initiating MRSA surveillance programs. Those institutions are actively planning to initiate programs ranging from testing high-risk patients to testing all patient admissions, the company said.
The Veterans Health Administration (VHA) is pursuing improving policies to reduce MRSA infection, the company said. In January, it issued a directive requiring all VHA facilities to implement MRSA surveillance programs of all patients. While this directive does not mandate polymerase chain reaction (PCR) testing, it advises molecular-based testing wherever feasible. Cepheid is currently working with VA hospitals across the country to potentially deploy Xpert MRSA in compliance with this directive.
“Patients that are potential carriers of MRSA are admitted to the hospital at all hours of the day and night,” said David Persing, MD, PhD, chief medical and technology officer of Cepheid. “But until now, the technology has not existed to provide MRSA STAT testing to enable real-time on-demand patient management decisions and reduce the spread of infection.”
MRSA is a bacterium that is resistant to antibiotics including methicillin, oxacillin, penicillin and amoxicillin affecting those with weakened immune systems such as hospital patients and nursing home residents. When MRSA enters the body through the skin it can cause serious skin infections, and if it enters the bloodstream or lungs, it can cause critical blood infections, pneumonia and even death.
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that the company said represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. Cepheid says that the GeneXpert System is the only system to combine on-board sample preparation with real-time polymerase chain reaction amplification and detection functions for fully integrated and automated nucleic acid analysis.
The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has “a variety of configurations to meet the broad range of testing demands of any clinical environment,” the company said.
Elsewhere in the product pipeline:
• Affymetrix (Santa Clara, California) reported commercial launch of its GeneChip HT Array Plate System, a microarray processing platform that analyzes up to 96 samples at a time. The company said that the HT Array Plates offer the same content as the traditional cartridges in a format designed for larger-scale studies. The automated system provides consistent microarray data for every experimental sample run, which reduces the need to reanalyze samples. The HT Array Plate System also helps ensure reproducible data for large-scale studies that are conducted in multiple laboratories. Compared to manual methods, the complete system reduces the overall required labor time by at least 40%, according to the company. Affymetrix develops products that provide researchers with a more complete view of the genome.
• Applied Spine Technologies (New Haven, Connecticut) reported that Triangle Orthopaedic Associates and the North Carolina Specialty Hospital (Durham, North Carolina) are the first in the U.S. to use the company’s Stabilimax NZ Dynamic Spine Stabilization System as part of a controlled clinical trial comparing posterior dynamic stabilization using the Stabilimax NZ to patients receiving traditional fusion stabilization to treat degenerative lumbar spinal stenosis. A total of 266 Stabilimax NZ patients and 133 control patients are expected to be enrolled in the trials. “The purpose of our study is to evaluate and compare the improvement observed in patients receiving flexible stabilization using the Stabilimax NZ device versus patients receiving the traditional fusion-type stabilization,” said Thomas Dimmig, MD, a spine surgeon with Triangle and a principal investigator for the study at North Carolina Specialty Hospital. Applied Spine develops Stabilimax NZ, a posterior dynamic stabilization device designed to support an injured or degenerated spine without eliminating motion.
• Aspect Medical Systems (Newton, Massachusetts) reported initiation of two studies being conducted with the Cleveland Clinic (Cleveland) to investigate the impact of anesthetic management techniques on patient outcomes. The first study seeks to determine if avoidance of deep anesthesia, administration of steroids and control of blood sugar levels improves outcomes in patients undergoing major vascular surgery. The second study will test the hypothesis that avoiding deep general anesthesia reduces cancer recurrence rates in women undergoing surgery for breast cancer. Both studies will use the company’s BIS monitoring system to assess depth of anesthesia. The vascular study is expected to evaluate up to 900 patients scheduled for elective major vascular surgeries at Cleveland Clinic hospitals. Researchers will assess multiple outcome measures during and after surgery, including the incidence of major perioperative morbidity such as heart attack. The second trial is expected to evaluate up to 1,100 breast cancer patients scheduled to undergo mastectomies. Patients will be randomly assigned to regional anesthesia/analgesia with sedation or light anesthesia, or to a full general anesthetic and morphine analgesia. Participants will be followed for up to 10 years to determine the rate of cancer recurrence or metastasis. Using a sensor placed on the patient’s forehead, BIS monitoring translates information from the electroencephalogram into a single number that represents each patient’s level of consciousness. The BIS value ranges from 100 (indicating an awake patient) to zero (indicating absence of brain activity).
• ATS Medical (Minneapolis) reported submitting its request for an Investigational Device Exemption for its 3f Enable Aortic Bioprosthesis to the FDA for review, the next step in the process necessary to begin U.S. clinical trials. The ATS 3f Enable Aortic Bioprosthesis is the company’s second tissue valve product to market. The company calls it a “first of its kind prosthesis” designed to eliminate the time-consuming procedure of placing and tying the 12-20 or more sutures necessary to implant current valve replacements. A flexible Nitinol frame has been integrated with the companies’ initial tissue valve offering, the ATS 3f Aortic Bioprosthesis. During an open chest procedure and after removal of the diseased valve, the ATS 3f Enable Aortic Bioprosthesis is folded into a reduced geometry and diameter that is positioned in the native valve annulus with a proprietary delivery system. Upon deployment, the Nitinol frame and valve expand within the annulus applying a continuous radial force that effectively implants the valve without the need for sutures. Overall procedure time and specifically, cardio-pulmonary bypass time can be significantly reduced.
• BioImagene (Cupertino, California), a provider of digital pathology solutions, reported receiving FDA clearance for the use of its Pathiam Imaging Software for HER2/neu for in vitro diagnostic use. Pathiam is intended for use as an accessory to the Dako HercepTest to aid a pathologist in semi-quantitative measurement of HER2/neu in breast cancer tissue. When used with the Dako HercepTest it is an aid in the assessment of breast cancer patients for whom Herceptin treatment is being considered. The imaging software detects and classifies cells of interest by analyzing digitized images of microscope slides based on recognition of cellular objects of a color, size and shape. The Pathiam analysis algorithm enables pathologists to provide accurate and objective quantitation of tissue samples stained with HER2/neu, BioImagene said. BioImagene is a provider of image informatics solutions for life sciences research, drug discovery and development and digital pathology and has developed a product line from the web-enabled management platform 3i. With the exception of Pathiam Imaging Software for HER2/neu, BioImagene products are for research use only.
• Cardica (Redwood City, California) reported completing enrollment of about 220 patients in a pivotal clinical trial in U.S. and Europe to evaluate safety/efficacy of its PAS-Port Proximal Anastomosis System during coronary artery bypass graft (CABG) surgery. The PAS-Port system, commercially available in Japan and Europe, creates a secure connection, or anastomosis, between a vein graft and the aorta, the main artery in the human body, during bypass procedures, Cardica said. The trial is being conducted in the U.S. under an Investigational Device Exemption. Two venous bypass grafts were randomly selected in each patient to be connected to the aorta using either the PAS-Port device or the conventional hand-sewn technique. Patients will receive a follow-up angiogram nine months after their procedure to determine patency (degree of openness of the vein graft) of both PAS-Port and control grafts. If the results of this trial are favorable, the company plans to submit a 510(k) application for the PAS-Port system to the FDA in early 2008. The PAS-Port system is designed to allow the surgeon to load the bypass graft and rapidly complete the anastomosis, typically in about two minutes, with little or no injury to the bypass graft vessel or the aorta. Cardica makes automated anastomosis systems for coronary artery bypass graft (CABG) surgery.
• CISBIO (Saclay, France), a developer of diagnostic assays for the quantification of tumor markers, reported that the Mesomark Assay, the world’s first in vitro test for managing patients with mesothelioma, an aggressive and deadly form of cancer, has been approved by the FDA. The Mesomark test is developed and manufactured by Fujirebio Diagnostics (Malvern, Pennsylvania). CISBIO is the exclusive distributor of Mesomark in Europe, where it is currently undergoing evaluation for clinical use. The Mesomark test is now accessible to physicians across the U.S. for monitoring patients who have been diagnosed with epithelioid or biphasic mesothelioma. The minimally-invasive tool requires only a blood sample.
• Cook Medical (Bloomington, Indiana) reports that a study that examined the times in which Cook’s G nther Tulip vena cava filter could be successfully retrieved from patients has presented what it called “breakthrough” results. It said that clinical data revealed that the filter can be safely retrieved up to 12 weeks post-implant with a success rate of 94% when used for prevention of pulmonary embolism. The G nther Tulip is an implanted device used to capture blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. Cook Medical produces numerous medical devices.
Separately, Cook reported its new Miraflex microcatheter, designed especially to complement the company’s existing embolization products. The microcatheter can essentially “navigate” all over the body — literally from head to toe — with the indicated use being in small vessels or in “super-selective” anatomy for diagnostics and interventional procedures, including neurological, peripheral or coronary vasculature. The company recently reported FDA clearance of the device.
• CryoCath Technologies (Montreal) said it has received FDA approval to expand its pivotal Investigational Device Exemption STOP AF trial for Arctic Front to the full cohort of patients in all 20 centers. The trial is designed to demonstrate Arctic Front’s clinical and therapeutic effectiveness in treating paroxysmal Atrial Fibrillation (AF) when compared to traditional medical therapy. CryoCath develops cryotherapy products to treat cardiovascular disease.
• Researchers at Pratt School of Engineering at Duke University (Durham, North Carolina) have developed what they say is laboratory tests on human tissue using a light-based, fiber optic probe that can detect the earliest signs of cancer in epithelial cells, those cells that line internal organs such as the lungs, esophagus and colon. According to Adam Wax, PhD, the Duke researcher leading the study, the next step will be the development of a clinical trial, funded by the National Cancer Institute, in collaboration with researchers at Duke University Medical Center. According to the researchers, about 85% of all cancers start in the epithelium, so that while a patient may die of brain cancer, the cancer may have begun in the lining of the colon. The technique is known as fa/LCl (for frequency-domain angle-resolved low coherence interferometry).
• EPIX Pharmaceuticals (Lexington, Massachusetts) reported an update regarding the status of its formal appeal to the Center for Drug Evaluation and Research (CDER) at the FDA, asking the CDER director to approve the company’s novel blood-pool imaging agent Vasovist (gadofosveset trisodium injection). The appeal was submitted on Feb. 28, and the company said it is in discussions with the agency regarding the appeals process. It added: “Based on these discussions, it is now clear that the Agency’s decision-making process will extend beyond the originally anticipated 30-day period.” Vasovist is an injectable intravascular contrast agent designed to provide visual imaging of the vascular system through MRA. EPIX Pharmaceuticals has five internally-discovered therapeutic and imaging drug candidates currently in clinical trials targeting conditions such as depression, Alzheimer’s disease, cardiovascular disease and obesity.
• Ethicon Endo-Surgery (Cincinnati) reported submitting a premarket approval application with the FDA for its adjustable gastric band, an implantable device intended to treat morbid obesity. The device is a soft, adjustable band that is fitted around the uppermost part of the stomach during laparoscopic surgery, creating a small pouch and restricting food consumption. Ethicon Endo-Surgery, a J&J company, makes devices for minimally-invasive and open surgical procedures.
• E-Z-EM (Lake Success, New York) reported that it has received 510(k) clearance for its EmpowerMR injector system, the company’s first product for the MRI market. EmpowerMR uses features designed to cope with the problem of electrical interference in the magnetic field of the MR scanner. MRI systems operate by detecting minute variances in the alignment of molecules within certain tissues of the human body. To detect these variances, MR systems create powerful magnetic fields, and require the use of non-magnetic materials and components in the immediate surroundings of the scanner. Electromechanical devices like injector systems can create both electric and magnetic fields that cause electrical interference with the scanner during the imaging process, leading to image distortion or artifacts. To minimize this problem, EmpowerMR uses a hydraulic control system instead of the shielded electrical control components used by most other MR injector systems. EmpowerMR has no shielded iron core motors, piezoelectric motors or electrically active motor control circuitry adjacent to the scanner, which significantly minimizes the prospect of electrical interference with the scanner’s magnetic field. EmpowerMR provides for utilization in MR field strengths up to 7 Tesla. E-Z-EM makes contrast agents for gastrointestinal radiology.
• FoxHollow Technologies (Redwood City, California) reported submitting a 510(k) application to the FDA for its NightHawk plaque excision system. The intended use of the NightHawk System is in the evaluation of peripheral vascular morphology. The device uses fiber optic technology embedded in the catheter and allows the physician to visualize the vascular morphology and wall structures. The OCT embedded catheters are designed for use as an adjunct to conventional angiography to provide an image of the vessel lumen and wall structures. FoxHollow Technologies makes endovascular therapeutic devices for the treatment of peripheral artery disease.
• Gen-Probe (San Diego) said that a research test for the specific prostate cancer gene PCA3 in urine predicted the results of repeat biopsies more accurately than traditional prostate specific antigen (PSA) testing, as reported in the March issue of Urology. Gen-Probe’s PCA3 research test detects the over-expression of PCA3 mRNA in urine. Previous studies have shown that PCA3 is over-expressed, relative to benign cells, by 60- to 100-fold in more than 90% of prostate tumors, indicating that the gene may be a useful biomarker for prostate cancer. In contrast, serum PSA may be elevated due to a number of benign conditions, resulting in “false positive” results and unnecessary biopsies. Gen-Probe makes nucleic acid tests that are used primarily to diagnose human diseases and screen donated human blood.
• Guardian Technologies International (Herndon, Virginia) reported that the clinical survey results employing its mapping CAD technology have demonstrated that it is capable of accurately detecting and characterizing tumors in screening mammograms. The study also found that signature mapping CAD is a highly sensitive tool for accurately detecting lesions in dense breast tissue that are undetectable with the human eye. This initiative focused on identification, clarification, and clinical interpretation of both dense and fatty breast tissues. Low ranges of sensitivity for breast cancer detection have been directly attributed to the challenges of interpreting these types of images. The signature mapping algorithms employed in the study demonstrated that the process was effective in locating and characterizing these tumor types. Guardian Technologies International is a provider of security and healthcare solutions.
• Hospira (Lake Forest, Illinois) introduced a new wireless platform for its medication infusion devices that incorporates authentication standards and encryption protocols to assist hospitals in securely transferring data and complying with patient confidentiality regulations. The new technology also provides a three- in-one wireless multi-band module for an infusion system, enabling hospitals to select any of three frequency modes for communication. The platform’s expanded security options help ensure only designated, approved hospital staff access clinical data transmitted between the devices and hospital information technology systems as part of the intravenous medication administration process. Hospira is a hospital products company.
• HydroCision (Billerica, Massachusetts) launched a new product, MicroResector MD, at the 2007 annual meeting of the American Association of Neurological Surgeons (AANS; Rolling Meadows, Illinois), in Washington. The MicroResector MD is based on HydroCision’s HydroDiscectomy platform, designed to use a high-velocity waterjet to quickly decompress herniated discs, providing relief to patients suffering from chronic back and/or leg pain. The HydroDiscectomy procedure bridges the gap between conservative therapy and conventional open surgery, according to the company. HydroDiscectomy is intended to offer an option to patients who have failed conservative treatments. In a recent retrospective study of the outcomes of 27 patients who underwent a HydroDiscectomy procedure to treat their lumbar herniated disc, these patients required zero revision procedures within the first year after surgery, compared to 34 patients who underwent a microdiscectomy spine surgery using conventional techniques to treat a lumbar herniation, 17.6% of whom required a revision microdiscectomy within a year after surgery. HydroCision is a developer and distributor of fluidjet-based surgical tools.
• I-Flow (Lake Forest, California) reported that preliminary results of an ON-Q prospective human study in colorectal surgery were presented at the annual meeting of the Surgical Infection Society (Ann Arbor, Michigan) in Toronto. The trial was designed to evaluate the effects of ON-Q PainBuster with the ON-Q SilverSoaker antimicrobial catheter on surgical site infections. The early results of the ongoing study indicate a statistically significant reduction in the rate of surgical site infections and a statistically significant decrease in length of hospital stay for patients who received ON-Q versus those who received only narcotics. The results revealed that at 30 days after their surgery, patients who received ON-Q had a statistically significant lower risk of developing surgical site infections — 0% — than the control group — 22.9%. Additionally, patients treated with ON-Q had statistically significant shorter hospital stays — 5.1 days — than the control group — 6.9 days. ON-Q is a device that consists of a small balloon pump that holds a local anesthetic (a pain-numbing medicine) and delivers it automatically through a specially designed catheter to provide even distribution of local anesthetic over a wider area, as compared to other catheters, because of its patented wicking capabilities. I-Flow makes drug delivery systems and pain relief solutions.
• IMPAC Medical Systems (IMPAC; Sunnyvale, California), an Elekta company and provider of information technology solutions for anatomic pathology and oncology care, introduces the PowerPath Advanced Materials Processing (AMP) module. AMP enhances patient safety with expanded use of barcode technology to track case materials from accessioning to sign-out. AMP provides laboratories with significant opportunities to improve workflow efficiency, accountability and responsiveness, potentially resulting in revenue increases and cost savings.
• Rapid Pathogen Screening (RPS; South Williamsport, Pennsylvania) reported that a cost effectiveness analysis from the Health Economics Consulting Group (HECG) showede a savings of more than $400 million a year to the healthcare system if the RPS Adeno Detector were used on all 6 million annual cases of acute conjunctivitis, or pink eye. The Adeno Detector for detection of viral conjunctivitis uses a small sample of tear fluid and provides a result in 10 minutes and essentially makes available an accurate laboratory confirmation of adenoviral conjunctivitis at the time of the patient exam. The company said the study confirms a November 2006 report that demonstrated a 115.5% savings in the weighted average costs of treatments for acute conjunctivitis when the physician uses the waived RPS Other POC diagnostic tests in the company’s product pipeline include a detector of Herpes Simplex Virus, allergies, and Chlamydia Trachomatis.
• Oculus Innovative Sciences (Petaluma, California) reported receiving Institutional Review Board (IRB) approval from six sites within the U.S. to participate in its Phase II clinical trial evaluating the preliminary safety and efficacy of topical Dermacyn Wound Care vs. systemic oral antibiotics for the treatment of mild diabetic foot infections. Dermacyn is a solution containing oxychlorine compounds manufactured using Oculus’ Microcyn Technology. The primary endpoint of the trial will be clinical cure or improvement of infection. Oculus expects results from the study in 3Q07, followed by the initiation of two larger, pivotal Phase III trials. The randomized, open-label three-arm study will enroll 60 total patients at up to 13 U.S. sites. Patients will be randomized 3:1 to receive Dermacyn, Dermacyn in combination with the oral antibiotic levofloxacin, or saline plus levofloxacin. The twenty patients in each arm will be treated over ten days, each time their wound dressing is reapplied. After 10 days, patients will stop treatment and return two weeks later for a follow-up assessment. Oculus manufactures Microcyn Technology-based products intended to help prevent and treat infections in chronic and acute wounds.
• Scivanta Medical (Spring Lake, New Jersey), an emerging med-tech company, is developing the Hickey Cardiac Monitoring System (HCMS). The goal of the device is to provide the primary measurements of cardiac performance in a less-invasive and more cost-effective manner. Scivanta licensed the technology, LaVance said, in November from the University of Buffalo (Buffalo, New York). The HCMS is a minimally-invasive cardiac monitoring device using an esophageal two-balloon catheter that provides cardiac performance data similar to that obtained through pulmonary artery catheters (PACs), such as the Swan-Ganz catheter. According to the company, the device addresses many of the shortcomings of PACs, by bringing minimally-invasive cardiac monitoring technology to intensive care units and to cardiology, surgical and anesthesia markets — with the minimally invasive route because very much more traveled in medicine these days. Because Swan-Ganz and other PACs must be inserted through an artery by a trained physician, the use of these devices is limited to critical care settings, Scivanta says.
• Siemens Medical Solutions Diagnostics (Tarrytown, New York) reported the launch of the Clinitek Advantus urine chemistry analyzer, the newest member of the Clinitek family of urine analyzers. The Clinitek Advantus analyzer is designed to enable automated reading of Siemens’ Multistix family of urinalysis testing strips in medium to high-throughput settings. The Clinitek Advantus Analyzer is a semi-automatic urine chemistry analyzer that can perform up to 500 tests per hour, the company said. The enhanced analyzer is network-ready and delivers improvements such as the ability to consolidate microscopic test results. Technicians can enter results using the analyzer’s touch screen or PC keyboard. The analyzer has enhanced quality control capability and automatically prompts technicians to perform QC testing. The unit includes QC lock-out and a simple one-touch operation allowing users to switch between different test configurations. Consolidated reports, including off-line urine microscopy test results, can be printed and/or transmitted to laboratory or healthcare information systems (LIS or HIS).
• Signalife (Greenville, South Carolina) reported the development of software that can provide objective evaluation of electrocardiograph performance, including its Fidelity 100 ECG system. Presently, the objective evaluation of different ECG recorders is performed by parallel recordings of the device under test and the control device. In the case of differences between the two, it is difficult to determine which device recorded the source signal with higher fidelity. A combination of the Signalife simulator and newly developed proprietary software will allow the objective comparison of different electrocardiograph devices. Signalife is a life sciences company focused on the monitoring and detection of disease through continuous biomedical signal monitoring.
• Sonic Innovations (Salt Lake City) introduced Velocity, its new digital hearing aid product family at the American Academy of Audiology National Convention and Exposition. The systems offered in Velocity give hearing impaired consumers the ability to use their hearing aids “hands-free.” Using environmental sound cues, Velocity is able to automatically adjust the hearing aid settings to best meet the challenges of a particular listening situation, without requiring the wearer to press a button. Velocity features patented digital signal processing and advanced noise reduction, patent-pending adaptive directional technology, automatic directionality, adaptive feedback cancellation and several advanced user options, including patient-friendly voice alerts and automatic telephone listening settings that are activated when a conventional telephone is held to the ear. The company also introduced the ion 200, an open behind-the-ear product, at the The ion 200 technologies combine to automatically adjust the hearing aid as the consumer’s listening environment changes. Sonic Innovations makes digital hearing aids.
• Spectral Diagnostics (Toronto) delivered a presentation documenting the efficacy of its proprietary RapidWN West Nile Virus IgM Test at the 39th Annual Oak Ridge Conference, titled “Harnessing New Technology for Clinical Diagnostics.” The presentation outlines performance characteristics, as well as the safety and effectiveness, of the assay. Included in the data are results from studies at the National Microbiology Laboratory in Winnipeg, where Spectral’s assay was found to correlate with the gold standard test, the Plaque Reduction and Neutralization (PRNT) assay, and 100 % of the time in acute cases of West Nile infection. The PRNT assay takes weeks to perform and requires specialized technicians and equipment. Spectral’s assay gives results in less than thirty minutes and requires no special equipment or training. Spectral provides accurate and timely information to clinicians enabling the early initiation of appropriate and targeted therapy.
• Stereotaxis (St. Louis) reported that its partnered magnetically enabled 8 mm ablation catheter has received FDA approval and will soon be commercially available in the U.S. The 8 mm catheter expands electrophysiology applications for the Stereotaxis magnetic navigation system by providing physicians the ability to deliver high power ablations for the treatment of atrial arrhythmias. Atrial flutter, a common atrial arrhythmia estimated to represent 25% of the over 400,000 ablation procedures performed worldwide each year, is routinely treated with 8 mm catheters. Stereotaxis makes cardiology instrument control systems for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias.
• 3M Diagnostics (St. Paul, Minnesota), a new business unit of 3M, unveiled in early March, introduced its first product in early April in Europe, at the 17th European Congress of Clinical Microbiology and Infectious Diseases in Munich, Germany. This first product, designed for hospitals fighting the battle to stop the spread of methicillin-resistant Staphylococcus aureus, is the 3M BacLite Rapid MRSA test. 3M said it is the first rapid culture-based test that can “effectively and reliably” detect the presence or absence of MRSA in high-risk patients within five hours. 3M said that the new 3M BacLite Rapid MRSA Test will help clinicians quickly identify MRSA-colonized patients so they can proactively manage carriers. Importantly, the company said, a confirmed negative test result is available within five hours, and a confirmed positive result is available in 24 hours. Hospitals would be required to buy 3M’s instrument system to run the assay, but more tests are planned as applications for the instrumentation in the future, Dillow said.
• TransMedics (Andover, Massachusetts), a developer of solutions for organ transplant technologies, reported receiving investigational device exemption approval to initiate the pilot phase of the PROCEED multi-center clinical trial in the U.S. for its Organ Care System (OCS). The PROCEED trial will evaluate the safety and performance of the OCS for heart transplants in the U.S. The company said the OCS represents an advancement in the practice of organ transplant for end-stage organ failure and is designed to maintain organs in a warm, functioning, “living” state outside of the body. Using the OCS, hearts are maintained in a beating, functioning state during transport from organ donor to recipient. This design, the company said, optimizes organ health and allows ex vivo clinical evaluation for the first time ever. The OCS offers the real potential of increasing the availability of donor organs and dramatically reducing the cost of treatment for the large and growing population of end-stage organ failure patients worldwide. Physicians can perform visual, functional and metabolic assessment of the organ to reduce the risk of organ rejection and increase the number of organs accepted for transplant. Current cold ischemic preservation and transportation methods create severe time limitations, as well as time dependant injury to the organ, resulting in significant underutilization of the current pool of consented, donated organs.
• Visionsense (Orangeburg, New York) reported availability of its new distal “chip-on-a-stick” 3.4 mm 3D stereoscopic camera for minimally-invasive surgery. The camera technology provides image quality equivalent to High Definition (HD) as not optically “diffraction limited.” The company says that the camera provides a real-time “natural” Stereovision, 3D measurements and image fusion that combines Stereovision with MRI, CT or ultrasound and displays both merged. Visionsense said that the camera enables “new minimally invasive surgical specialties and procedures that are underserved by traditional 2D visualization products, in markets such as: spine, neurosurgery, gynecology, urology, general surgery, micro, plastic and orthopedics.”
• Wright Medical Group (Arlington, Tennessee) reported the commercial launch of its Carolina Jones Fracture System for foot and ankle surgery. The system is the latest addition to Wright’s market-leading line of reconstructive products for foot and ankle procedures. The Carolina system is the first major product designed specifically for treatment of Jones fractures of the fifth metatarsal of the foot, the company said. Jones fractures can be a disabling injury, and are common in young, athletic patients and geriatric patients. Wright makes reconstructive joint devices and biologics.