Ceramic implants have been popular for knee and hip replacements for some time, and now the material is being used in a spinal implant for the first time in the U.S., and possibly the world, in humans with the recent FDA clearance of a spinal spacer system.
The device is the Arx ceramic spinal spacer system, developed by privately held Amedica (Salt Lake City), as another component of its ceramic technology platform.
According to Cameron Rouns, vice president of sales and marketing, the company was founded in 1996 specifically to look at the orthopedic needs that ceramic composites could bring to patients.
“The company worked very diligently to refine these technology platforms both in super strong articulation applications for hip bearings, knee bearings and spinal disc implants,” he told Biomedical Business & Technology, “and then secondarily, to develop a technology platform that facilitated bony in-growth and adhesion.”
The Arx system provides a biocompatible implant based on Amedica’s patented MC2 technology that offers physicians and patients an alternative to other synthetic and allograft bone implants used for the restoration of spinal anatomy.
Arx spinal implants are designed as vertebral body replacements for use in the thoraco-lumbar region of the spine to replace collapsed, damaged or unstable vertebral bodies, resulting from such causes as degenerative disease and/or trauma.
Such spinal implants, the company said, are estimated to comprise an annual U.S. market segment of more than $600 million, which Rouns called “a conservative figure.”
In articulated joints such as hip and knee implants and even with artificial spinal discs – which the company also is developing and expects to begin clinical work on in the U.S. by mid-2007 – the primary advantage of ceramic materials is their ultra-low-wear properties. For fusion applications in the spine such as the Arx system, the primary advantage of ceramics relates to its excellent diagnostic imaging properties.
Although there are alternative implants in the marketplace, such as those made with titanium and PEEK polymer, as well as grafts taken from human cadavers, each falls short of the combined valuable attributes of Amedica’s ceramic spinal spacer system, the company said
“If you look at what is limiting the synthetic alternatives right now, it’s the fact that PEEK [polymer] is radiotransparent so you can’t see it,” Rouns said. On the other end of the spectrum, he noted that titanium cages “don’t have very good imaging qualities for the radiopacity portion [of the device] that you can’t see through, or on an MRI you get a halo effect.”
Elsewhere in the product pipeline:
• Accuray (Sunnyvale, California), manufacturer of the first radiosurgery system that uses intelligent robotics to treat tumors anywhere in the body, reported that clinicians worldwide are using the CyberKnife Robotic Radiosurgery System to treat tumors outside the head at a rapidly increasing rate. Extracranial tumor treatment now represents more than 50% of all procedures performed with the CyberKnife System in the U.S., with the treatment of lung tumors outpacing all other tumor treatments in the body. Since the July 2004 introduction of the Synchrony Respiratory Tracking System, lung tumor treatments have increased threefold annually. Synchrony allows patients to breathe normally throughout their treatment without uncomfortable breath-holding or radiation beam gating techniques so clinicians can track, detect and correct for tumor and patient movement throughout the treatment minimizing damage to healthy tissue or critical structures.
• Aethlon Medical (San Diego) reported that it would expand the applications of its Hemopurifier technology to include the treatment of cancer. The company said it plans to combine the core principles of its Hemopurifier platform technology with intellectual property licensed from Boston University as a means to help prevent the spread of cancer following surgery. The use of growth factors and related agents associated with the wound healing process has proved effective in controlling the growth and spread of many types of cancer; however, using these agents following surgery would interfere with the healing process. The post-surgery deployment of the Hemopurifier with immobilized growth factor affinity agents offers the potential to control the levels of growth factors in circulation during this critical period while not significantly affecting local levels near the surgical wound. The treatment goal will be to block the surge in circulating growth factors, which occurs over a few days following surgery, without negatively affecting wound healing. Patients would then be able to return to the use of antiangiogenic drugs or other cancer therapies. If successful, the company said use of the Hemopurifier to treat cancer would make it possible to provide surgical interventions in cases where surgery is not presently considered, and will add a significant margin of safety in cases where surgery is considered a viable treatment option.
• AFP Imaging (Elmsford, New York) reported a new digital dental product introduction at the opening of the annual Chicago Midwinter Dental Meeting, unveiling its new Rotograph Digital Panoramic X-Ray machine and software under the Dent-X brand. The company said the Rotograph Digital is a cost-effective solution for panoramic dental imaging. Digital panoramics are advantageous large-format images of the patient’s teeth, jaw, and surrounding bone structure for a more complete analysis and diagnosis, without the use of X-ray film. Dent-X has sold the analog film-based version of the Rotograph Plus for many years. This new digital product introduction further builds upon an established, successful product with a proven track record. AFP Imaging said that, through its Dent-X brand leadership, it has become a key player in dental imaging as it continues to rapidly transition from its traditional business in film-based imaging to a global position in digital dental imaging technologies. Now, with the Rotograph Digital addition to its Strato Digital, the company completes its line of digital panoramic X-ray machines for use by dentists.
• Beckman Coulter (Fullerton, California) reported that its newest chemistry-immunoassay workstation, the UniCel DxC 600i Synchron Access clinical system, has been cleared by the FDA. With an on-board capacity of 89 reagents, the second-generation workcell offers a menu of more than 150 different tests, ranging from cardiac and tumor markers to tests for renal function and diabetes. The DxC 600i, available for shipment in mid-2006, enables clinical laboratories to perform both chemistry and immunoassay testing simultaneously from a single point of sample entry. The company said the DxC 600i will be the only system of its kind with closed-tube sampling and closed-tube aliquotting capabilities, eliminating the de-capping and re-capping steps in the laboratory process. The system offers a throughput up to 990 chemistry tests per hour and up to 100 immunoassay tests per hour.
• Cardiac Science (Bothell, Washington) reported that the FDA has granted the company 510(k) regulatory clearance to market a new “crash cart” defibrillator-monitor designed specifically for use by medical professionals to respond to cardiac emergencies in hospital settings. The new defibrillator will be sold exclusively by GE Healthcare (Waukesha, Wisconsin) to hospitals in the U.S. and Canada under the Cardiac Science Powerheart brand, and to customers outside North America under the GE Responder brand. Initial shipments are expected to take place during 2Q06. The new defibrillator-monitor is a lightweight, rugged and portable device with resuscitation and pacing therapies. Operators are guided by a combination of programmable text prompts, audible alarms and visible indicators. The defibrillator-monitor incorporates the company’s STAR biphasic escalating shock energy technology, which automatically adjusts the magnitude of the defibrillation shock based upon each patient’s body type and also employs Cardiac Science’s RHYTHMx software, which provides heart rhythm analysis and shock advice to effectively address life- threatening arrhythmias.
• Many people will suffer from severe back pain at some point in their lives – about 80% of the U.S. population, estimates spine care firm CERT Health Sciences (Baltimore) – yet the options for effective treatment are few. Offering long-term relief without the use of narcotics, physical therapy or invasive surgery, CERT Health Sciences has developed the SpineMED decompression table, the next generation of spinal decompression technology that is able to isolate and rehydrate debilitated spinal discs. “What spinal decompression really does is create the environment that allows the body to heal naturally,” Tim Emsky, co-founder and managing director of CERT Health Sciences, told BB&T. “It’s so simple, but the results are unbelievable.” With the non-surgical SpineMED treatment, “not only can we repair disc herniations through a very simple painless procedure with no side effects, but what we’ve also found is that we can restore the fluid content in the discs,” he said. Though spinal decompression – removing the pressure on the spine through distraction or positioning – as a treatment option is not new, Emsky said it was limited by side effects and uncomfortable restraint systems. Unlike other decompression tables, SpineMED does not use antiquated traction components such as pulleys, drums, ropes and pelvic harnesses.
• Clearant (Los Angeles) reported that the U.S. Patent and Trademark Office issued to Clearant patents No. 6,979,829 for “Devices and methods for determining the amount of energy absorbed during irradiation” and No. 6,946,098 for “Methods for sterilizing biological materials.” The patents cover technology used in the validation and application of the Clearant Process for pathogen inactivation. The first patent covers the ability to measure the dose of irradiation received by a product at low temperature. The second patent deals with the irradiation of biologics with at least one stabilizer in an amount effective to preserve the biological material for sterilization, where the biological material is glassy or vitrified.
• Clinical Data (Newton, Massachusetts), which is commercializing pharmacogenomics to guide drug utilization, reported that its Vital Diagnostics division has received FDA clearance to market a wide-range C-reactive protein (wrCRP) assay, trademarked as the Nanopia wrCRP Assay. The Nanopia wrCRP is an in vitro diagnostic used for the quantitative measurement of C-reactive protein in serum or plasma. C-reactive protein is a blood component that increases rapidly in infections, tissue trauma, surgery or other injury to the body.
• Dade Behring (Deerfield, Illinois) reported that it has launched the Cyclosporine Extended Range test for use on its Dimension family of chemistry analyzers and the V-Twin and Viva-E drug testing analyzers. The Cyclosporine Extended Range test, or the C2 monitoring test, is a new, more clinically sensitive method used to monitor Cyclosporine in transplant patients. It is monitored within two hours of patients having ingested the immunosuppressant drug, which some studies have shown to be a better predictor of patient outcome. Dade Behring said it would continue to offer the original Cyclosporine test. The company said its two Dimension Cyclosporine tests are the only automated Cyclosporine tests on the market, requiring no manual pretreatment steps.
• Delcath Systems (Stamford, Connecticut) reported that it has completed a special protocol assessment and agreement with the FDA for the treatment of metastatic melanoma in the liver using the Delcath system – used to deliver high doses of chemotherapy to specific organs and body regions – with melphalan, an approved anticancer agent. The company said active patient enrollment for its pivotal Phase III clinical trial at the National Cancer Institute is expected to begin immediately. The randomized, multi-center trial will enroll 92 patients diagnosed with ocular and cutaneous melanoma metastatic to the liver. Patients will be randomized to either the Delcath system using melphalan or a control group receiving best alternative care. The primary endpoint is to determine whether patients using the Delcath system will experience a reduction in tumor burden or zero progression of the metastatic melanoma in their liver longer than those receiving best alternative care.
• Endologix (Irvine, California) reported that four-year patient follow-up data from the company’s Powerlink System pivotal clinical trial supports the safety and effectiveness of the Powerlink as an endoluminal stent graft in protecting patients from rupture of the abdominal aortic aneurysm (AAA). Data from 192 patients treated with the Powerlink System in Endologix’s pivotal clinical trial was presented at the International Congress XIX on Endovascular Interventions. The mean follow-up patient time was 36.1 months with a range of .03 to 62 months. Only 26 patients from the follow-up group required a secondary procedure and most were treated for Type II endoleak, indicating that the need for the secondary procedure was not device related. All cohorts treated with the Powerlink System experienced aneurysm sac diameter and volume reductions, shrinking of the aneurysm sac around the device, and minimal change in the length of the aorta from the most distal renal artery to aortic bifurcation. Of the 192 patients followed for 48 months, 97.9% of patients were free from AAA-related mortality, there were no reported aneurysm ruptures, there were no ePTFE graft material failures, there were no cobalt chromium stent graft failures or fatigue, and there was only one late conversion that occurred at one year.
• FoxHollow Technologies (Redwood City, California) reported that a multi-center evaluation of patients with critical limb ischemia found that 82% of patients who received plaque excision avoided an amputation or received a less extensive amputation than originally planned. Results of the study were published in the February issue of the Journal of Endovascular Therapy. The patient population was comprised of those who suffer from the most severe form of peripheral artery disease (PAD). Six months after the plaque excision procedure, 96% of the lesions remained free from re-treatment in patients without amputation. Patients enrolled in the study were treated with the company’s SilverHawk Plaque Excision System, a device used to remove plaque caused by PAD and restore blood flow to the legs, feet and toes.
• Gambro Renal Products (Lakewood, Colorado) said it has developed a “high-flux, steam sterilized pediatric dialyzer,” which it called the first to be marketed in the U.S. under a 510(k) clearance from the FDA. The Polyflux 6H dialyzer is designed for small patients, including children. “The Polyflux H takes into account the many complexities of pediatric chronic hemodialysis, such as patient age and weight, the size of the dialyzer and the biocompatibility of the dialyzer,” the company said. Marketing Director Helene Olefsky told BB&T that the “primary difference” between the Polyflux 6H and adult dialyzers is the size of the unit that acts as the artificial kidney. Whereas the so-called “surface area” of a dialyzer in the Polyflux family for adult patients would be about a 1.4 square meter surface area, the Polyflux 6H is about 0.6 meters square in surface area. The Polyflux H family comes in three sizes, with 1.4 being the smallest, she said. An important feature – and one of its biggest competitive advantages currently, she said – is the fact that the new pediatric dialyzer is steam-sterilized, which, “according to all the literature, [is] the safest sterilization method. None of our competitors right now use steam.”
• Given Imaging (Yokneam, Israel) reported that two independent studies concluded that PillCam ESO is an accurate, noninvasive alternative to upper endoscopy, the current “gold standard” for evaluating patients and the most commonly performed procedure in detecting esophageal varices in cirrhotic patients. Both prospective studies were published in the January issue of Endoscopy. The first study of 32 cirrhotic patients assessed PillCam ESO’s ability to detect esophageal varices when compared to upper endoscopy in cirrhotic patients and evaluated patients’ tolerance and preference for each technique. It was concluded that PillCam ESO detected varices in 23 patients and signs of portal hypertension in 19 patients, matching the upper endoscopy findings. The patients studied also felt that PillCam ESO was more convenient and less uncomfortable than the standard endoscopy examination. A second study assessed 21 cirrhotic patients to determine the accuracy of PillCam ESO and how well patients tolerate the procedure compared to upper endoscopy for portal hypertension screening. The researchers concluded that there was complete diagnostic agreement on the presence or absence of esophageal varices in 85% patients. The study showed that the sensitivity of PillCam ESO for all large varices that require treatment was 100%. The study also reported that all 20 patients who swallowed the capsule preferred PillCam ESO.
• Kensey Nash (Exton, Pennsylvania) reported that a low major adverse cardiac event (MACE) rate of 3.2% was achieved in its recent ASPIRE study, which studied the effectiveness of the new TriActiv FX Embolic Protection System to reduce MACE during the treatment of diseased saphenous vein grafts (SVG). The company said that the 3.2% rate is the lowest recorded to date from a sizable multicenter study of the SVG population, and is less than half of the next best data set widely quoted by the cardiology community. The rate of heart attacks in the ASPIRE study, included as part of the MACE rate, was also a low 2.2%, which is a 67% reduction in the rate seen in the next best embolic protection device’s data set. The company also noted that procedure times were on average 15 minutes below the control cohort of the other embolic protection systems.
• Medtronic (Minneapolis) reported the addition of OptiVol Fluid Status Monitoring trend data available via the Medtronic CareLink Network. OptiVol Fluid Status Monitoring, which measures changes in impedance in the thoracic cavity, is a feature found on the InSync Sentry cardiac resynchronization therapy-defibrillator. Using low electrical pulses that travel across the thoracic cavity, the system can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the chest. Since normal fluid levels may vary from patient to patient and fluid accumulation can be either slow or rapid, OptiVol’s ability to measure fluid status trends over time can provide insights that are used in conjunction with ongoing monitoring of other patient symptoms. The company recently received FDA approval to provide this fluid trend data to physicians monitoring their patients via the Medtronic CareLink Network.
• Nektar Therapeutics (San Carlos, California) reported that the FDA has granted orphan drug designation to the first amphotericin B inhalation powder for prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy. Nektar developed the amphotericin B inhalation powder to target the lungs directly with this broad spectrum, fungicidal “gold standard” antifungal drug. Using a small proprietary pocket size inhaler, the company has conducted two Phase I trials and has long-term toxicity studies under way to support the planned pivotal trials early next year. Nektar scientists will present data from the first of two ongoing studies at the 2nd Advances Against Aspergillosis conference this week in Athens, Greece, and at Focus on Fungal Infections 16, next month in Las Vegas. Pivotal trials are on target to begin in early 2007.
• Norwood Abbey (Melbourne, Australia) reported that the U.S. Patent and Trademark Office has granted the first patent of the Norwood EyeCare patent portfolio, relating to EpiLASIK refractive surgery. The EpiLASIK procedure enables laser corrections to the eye without needing to make a cut through the eye. The removal of the need for a stromal cut is seen as a major advance over LASIK, the most commonly performed procedure. The company said U.S. patent No. 7,004,953 is believed to be the only granted patent that relates specifically to separating the epithelium layer from the surface of the cornea of an eye for the purpose of preparing the cornea for laser vision correction surgery.
• Palomar Medical Technologies (Burlington, Massachusetts) reported that the Palomar Lux1540 Fractional Laser Handpiece was introduced at the American Academy of Dermatology’s annual meeting that ended yesterday in San Francisco. The new handpiece uses patented fractional technology to create precisely defined zones of elevated temperature within the tissue. By varying treatment parameters, diverse effects can be induced in these zones with minimal damage to the surrounding tissue. Location, shape and dimensions of these columns can be accurately tuned to achieve the desired clinical effect. The handpiece is pending FDA clearance for soft tissue coagulation. The Lux1540 is an attachment for the StarLux Pulsed Light and Laser System, which offers aesthetic applications including hair removal and acne treatment. Palomar said it plans to begin shipments of the Lux1540 this summer.
• Planar Systems (Beaverton, Oregon), a provider of flat-panel display systems, reported that it has received FDA 510(k) clearance for Dome E4c, the first 4-megapixel color display medically certified for the viewing of diagnostic images. New features, such as the 16:9 display format, offer significantly more screen space and the ability to show 15 full-size 512 x 512 images on one screen. The Dome E4c supports an open architecture design which allows users to gain access to graphics standards, such as OpenGL and DirectX, providing the capability of 2-D color imaging, image fusion, high-speed 3-D and volumetric rendering for navigation and visualization functionality. The open architecture support also enables faster display performance and seamless integration of future standard enhancements. The Dome E4c is now shipping complete with Dome CXtra software, which monitors, controls and adjusts DICOM calibration of Dome displays to the users’ desired luminance across all gray levels. This display also is compatible with Dome Dashboard software, a console application which enables users to centrally manage, control and report on their entire line of Dome medical imaging displays.
• Point Biomedical (San Carlos, California), a developer of products for diagnostic, molecular imaging and drug delivery applications based on its biSphere technology, reported that the new drug application for CARDIOsphere (PB127) has been accepted for review by the FDA. CARDIOsphere is a myocardial perfusion agent used with ultrasound imaging. Point is seeking approval to market CARDIOsphere for the detection and localization of obstructive coronary artery disease. If approved in the U.S., the company said CARDIOsphere would allow cardiologists to diagnose coronary artery disease in the office or hospital using standard ultrasound equipment and without the need for radioactive isotopes.
• Two months after cutting nearly half its work force in the wake of increasing competition to its lead macular degeneration product, QLT (Vancouver, British Columbia) last month reported disappointing preliminary results for the Phase II trial of its light-activated drug lemuteporfin in benign prostatic hyperplasia (BPH). Three-month data showed that the BPH product, a photosensitizer formerly known as LT0074, did not meet the primary efficacy objective in the 180-patient study, showing no significant difference between the treatment and control groups. “These are preliminary data,” said Tamara Hicks, spokeswoman for QLT said. “We will continue to look at the data through six months.” Essentially, the early data pre-empts immediate plans for a Phase III study and potential approval of lemuteporfin in BPH, a non-malignant form of prostate disease and an indication that could generate worldwide drug sales of $250 million.
• Smith & Nephew Trauma (Memphis, Tennessee) reported that the FDA approved a label amendment for Supartz Joint Fluid Therapy. Although Supartz Joint Fluid Therapy is still indicated for five weekly injections, the amendment to the directions for use and the precaution section of the labeling now allow physicians to choose as few as three weekly injections for their patients with osteoarthritis knee pain if the physician judges the patients would experience benefit. Supartz Joint Fluid Therapy was the first hyaluronan joint fluid therapy commercially available for human use in treating osteoarthritis.
• Spacelabs Medical (Issaquah, Washington), a provider of patient monitoring systems, reported the availability of a new addition to the UltraviewSL line of patient monitors. The UltraviewSL 2600 is an advanced compact monitor with options that support open standards and connectivity, including WinDNA, which brings workstation functionality for charting and other hospital applications to the point of care. The monitor’s compact size and larger display, coupled with advanced monitoring features, provide a flexible solution that enables hospitals to augment their existing installation of Spacelabs monitoring. Additionally, a wireless networking option supports central surveillance during patient transport, enhancing patient safety and improving emergency response time. Together with Spacelabs’ new Clinical Event Interface to pagers and other hand-held devices, these capabilities serve to accelerate the flow of critical, time-sensitive patient information to caregivers, regardless of patient or caregiver location. Spacelabs Medical is a division of Spacelabs Healthcare, a subsidiary of OSI Systems.
• Stereotaxis (St. Louis) reported that Central Baptist Hospital (Lexington, Kentucky) became the first U.S. center to treat a patient’s cardiac arrhythmia using the company’s partnered 3-D Localized Ablation Catheter. This diagnostic and ablation catheter recently received FDA approval for use with the Stereotaxis Niobe Magnetic Navigation System. The company said the approval provides Stereotaxis Niobe system users in the U.S. with 3-D localization of the catheter tip, a function that offers physicians precise and efficient control of the catheter tip with constant feedback as to the exact location of the catheter in the anatomy.
• St. Jude Medical (St. Paul, Minnesota) last month reported the enrollment of the first patient in its ESCAPE (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere) migraine trial, making it the first company to begin enrollment in a U.S. clinical trial to evaluate the connection between patent foramen ovales (PFOs) and migraine headaches. The trial is a prospective, randomized, two-arm, double-blind multi-center trial, with the objective to determine if patients who undergo a PFO closure procedure have a decreased number of migraines over one-year follow-up as compared to those who are maintained only on drug therapy. The trial uses the company’s Premere system, acquired via its $74 million purchase of Velocimed (Maple Grove, Minnesota) in April 2005. According to St. Jude, critical features of its Premere PFO closure system include: flexible, low-profile anchors that conform to the septal wall; independent anchors to position for precise placement; limited surface area and prosthetic material designed to encourage rapid endothelialization and minimize the incidence of thromboembolic complications; and an adjustable tether to adapt to varying patient anatomies. While the Premere PFO closure system is CE-marked, it is not yet labeled in Europe for the treatment of migraines. The first patient, a Virginia woman, will be one of more than 500 patients to participate in the study, which received approval from the FDA for an investigational device exemption (IDE) in December 2005 after receiving its conditional approval for the trial last August.
• Tensys Medical (San Diego) said a new study published in the February issue of Anesthesia and Analgesia shows that the noninvasive Tensys T-line provides continuous beat-to-beat blood pressure (BP) measurement with comparable accuracy to that of an invasive radial arterial catheter (A-line). Researchers evaluated the T-line device in the operating room with patients undergoing general anesthesia. Systolic, diastolic and mean BP’s were compared from the T-line and the contra-lateral A-line. The mean errors reported were 1.7 +/- 7.0 for systolic, 2.3 +/- 6.9 for diastolic and 1.7 +/- 5.3 for mean. The noninvasive arterial waveforms produced from the T-line emulated those of the contra-lateral arterial catheters. The researchers concluded that the T-line provides an accurate noninvasive alternative for beat-to-beat blood pressure management.
• Thermage (Hayward, California) reported receiving regulatory clearance from Health Canada to market a new indication for its noninvasive, skin-tightening ThermaCool system in that country. The new indication clears the ThermaCool system for the non-surgical tightening of lax and/or redundant tissue of the torso and extremities. Previously, Thermage had been cleared in Canada for non-surgical brow lift and non-surgical tightening of periorbital and facial tissue, including rhytids. This new indication gives clinicians regulatory clearance to treat off-face. To reflect the company’s direction and the expanding suite of procedure offerings, Thermage said it is unveiling a new brand called Body by Thermage. Thermage said it also received Canadian clearance recently to market its new 3.0cm2 ThermaTip. The new tip is twice as large as the current 1.50cm2 ThermaTip, enabling physicians to treat larger areas in less time. The tip also has an expanded treatment range allowing Thermage procedures to be performed on the most sensitive patients. Distribution in Canada began earlier this month.
• ThermoGenesis (Rancho Cordova, California) reported that the Medical Devices Bureau of Health Canada has issued the company a license to market the AXP System in accordance with Health Canada’s Medical Device Regulations. This allows GE Healthcare (Waukesha, Wisconsin), the exclusive AXP System distributor, the right to begin its sales and marketing efforts to cord blood banks and hospitals in that country. The AXP System is a new automated system that allows stem cells from cord blood to be harvested in a functionally closed processing set. The company said the AXP System automates what was typically an 18-step manual process while improving the recovery rates of the stem cells.
• Vidar Systems (Herndon, Virginia), a provider of medical imaging technology, unveiled its new Vidar Vision Digital Radiography (DR) product line of full-featured, affordable DR systems designed for all radiography environments. The systems were presented at the European Congress of Radiology meeting in Vienna, Austria. The Vidar Vision 4000 – featuring a 4K detector for higher- resolution imaging needs – is designed for high-volume imaging centers, orthopedic practices and hospitals, while the Vidar Vision 2000, with a 2K detector, is ideal for lower volume, office-based use. Vidar Vision systems display images in 10 seconds or less, resulting in faster visualization and streamlined treatment for improved patient care.
• VirtualScopics (Rochester, New York), a developer of image-related biomarkers, said that the company co-authored and presented three studies at last month’s International Society for Optical Engineering medical imaging meeting in San Diego. The studies describe the use of automated computerized approaches to measure and evaluate progression of musculoskeletal disease as captured in images from MRI or computed tomography. The first presentation addressed the use of a computer software algorithm to segment and image cartilage degradation and thinning in MR images of rat knees, and showing that this automated approach yields similar results to that of using experts to review the images. The second presentation demonstrated the effectiveness of automating the detection of lesions over the course of a longitudinal study among subjects who have undergone hip replacement. The third study demonstrated the use of a computer algorithm to recognize bone landmarks in MR images of the knee, and to automatically identify and label the surrounding structures for analysis.
• VisualSonics (Toronto), a developer of high-resolution, ultrasound-based micro-imaging systems, reported at last month's American College of Cardiology (Bethesda, Maryland) conference new cardiovascular functionalities for its Vevo 770 system. The Tissue Doppler Imaging feature allows quantitative myocardial analysis to be performed and used for regional myocardial strain rate. A new integrated blood pressure analysis functionality allows the Vevo 770 system to integrate a blood pressure signal from a third-party continuous pressure monitoring system. Other new features include the automated left ventricular functional analysis, which provides semi-automated continuous tracing of the chamber walls in the left ventricle in either B- or M-Mode.