Elekta (Norcross, Georgia) has received FDA 510(k) clearance for what it calls a "revolutionary new weapon" with which to battle cancer, that is, its Elekta Synergy, a 3-D image-guided radiation therapy system. Synergy combines scanning (X-ray volume imaging) and delivery into one integrated treatment system to provide greater precision for targeting and treating tumors, the company said. "It's a huge thing for us, and it really represents a change with a very high potential in the business of radiation oncology, [both] in the way radiation oncology is going to be used and how the medical discipline is going to advance," said Tim Prosser, manager of strategic alliances and imaging for Elekta.

Imaging has always been used in radiation therapy to guide delivery, but it has been "very elementary and poor," Prosser told The BBI Newsletter. Some of the most recent advances in image-guidance of radiation therapy have occurred on other systems that are using a kind of 2-D stereoscopic method of imaging, he said. Prosser said that for years, companies have been using a "rudimentary" type of imaging with X-ray that gives a stereoscopic photograph effect. The Elekta Synergy system offers something of a holographic image that is produced by a laser so that you can walk around it in and see in three dimensions, he said.

The Synergy device adds a panel that is behind the patient, 98 degrees out from the table on which the patient is lying. Directly across from the panel is a device containing the X-ray tube. The machine can rotate completely around the patient 360 degrees, he said, so that you basically "acquire a CT [computed tomography] set like you would in radiology." Above the patient lying on the table is the device through which the dose of radiation is delivered. "Now, you get high-quality, high-contrast images in three dimensions like in a CT with the patient in the treatment position," Prosser said.

Elsewhere in the product pipeline:

Accentia (Tampa, Florida) said it has exclusively licensed worldwide rights to the patented digital writing pen device, CompuPen, developed by Pen2Net (St. Louis, Missouri) for healthcare applications. The CompuPen, using a regular ballpoint ink cartridge and a standard AA battery, writes like a regular ballpoint, but while writing, it creates a digital copy of the document using an optoelectronic sensor. The CompuPen holds over 200 pages of cursive. The documents are sent wirelessly via Bluetooth to a plug-in USB Bluetooth-enabled PC or server. Each pen has a unique identifier confirming authorship of each document, and the output of the pen features 128-bit encryption for added security.

Atrium Medical (Hudson, New Hampshire) reported the release of its lightweight, compact chest drain, the Express Mini 500. A recent study at the University of North Texas (Denton, Texas) has shown that using the Express Mini 500 allowed for patients to be removed from suction earlier (3.4 days on standard system vs. 1.2 days for Mini 500 users), were able to ambulate sooner (4.4 days on standard system vs. 1.2 for Mini 500 users), and were discharged sooner (5.6 days on standard system vs. 3.2 days for Mini 500 users).

Bayer Biological Products (BP; Research Triangle Park, North Carolina) reported the filing of a pre-approval supplement for BIO-SET, a new needleless device for the reconstitution and use of Kogenate FS (Antihemophilic Factor [Recombinant], Formulated with Sucrose) for the treatment of hemophilia A. The supplement filed with the FDA will be followed by filings with regulatory authorities in other countries, BP said. Upon approval, Kogenate FS with BIO-SET will be "the first and only self-contained device that provides a prefilled syringe for rapid and safe reconstitution and infusion without exposed needles," it said. Kogenate FS with BIO-SET involves no exposure to needles during the reconstitution process, no latex utilized in the system, and minimal risk of contamination during reconstitution because of the special vacuum seal.

Biotronik (Lake Oswego, Oregon) reported the first U.S. implantation of an implantable cardioverter defibrillator (ICD) that provides three essential therapies in a single device: cardiac resynchronization therapy (CRT) for treating heart failure, atrial therapy for atrial tachyarrhythmias, and ICD therapy for ventricular tachyarrhythmias. Dr. Kyong Turk performed the first implantation of the system at Nebraska Heart Institute (Lincoln, Nebraska), in an 84-year-old patient with advanced heart failure. Turk said, "If an implantable device can reduce AF burden, we can obtain more benefit from CRT. The Biotronik Tupos LV/ATx is a novel device that provides a range of therapies to treat a variety of cardiac disorders. As a result, the implanted device becomes a more cost-effective form of therapy." The patient was enrolled in Biotronik's latest investigational study aimed at evaluating the benefits of these combined therapies. The initial study will compare the clinical benefits of CRT in patients implanted with the Biotronik CRT-ICD to the benefits of CRT in patients implanted with market-released CRT-ICDs from Guidant (Indianapolis, Indiana) and Medtronic (Minneapolis, Minnesota), without atrial therapy.

CADx Systems (Beavercreek, Ohio) has received FDA approval of its Second Look Version 6.0 CAD software. CADx said approval of the new software makes it the industry leader for CAD performance, with FDA-approved claims of up to 96.2% overall sensitivity and specificity as low as 1.6 false positives per case. The new software was launched at the Radiological Society of North America meeting last month in Chicago, Illinois. The design of the Second Look platform enables the version 6.0 CAD software to operate at multiple sensitivity points, and provides the user with a choice of three operating points, one with higher sensitivity, another with lower false marks and a median selection that optimizes sensitivity and specificity.

CardioTech International (Woburn, Massachusetts) said it entered Phase II trials for its CardioPass coronary artery bypass graft following the mid-October implantation of the graft during a triple bypass procedure on a 76-year-old woman at the Institute for Cardiology (Porto Alegre, Brazil). Michael Szycher, chief executive officer, said, "With this third implantation, we are freezing the 'Nesralla' protocol and entering Phase II." Phase II trials will involve an additional 10 clinical centers in Brazil and Chile. CardioTech's vascular grafts are made of ChronoFlex, a family of polyurethanes the company said has been demonstrated to be biodurable and biocompatible.

Cytyc (Boxborough, Massachusetts) said more than 40 studies involving its ThinPrep Pap Test and ThinPrep Imaging System were presented in November during the annual meeting of the American Society of Cytopathology in Orlando, Florida. Two studies concluded that the ThinPrep Imaging System "greatly increases cytotechnologist screening productivity while at least maintaining, and sometimes improving, sensitivity/specificity at all diagnostic levels" and that the system "has the potential to further reduce screening errors as compared to a manual review method" for screening slides. Other studies reported on a range of subjects relating to the ThinPrep System, including increased sensitivity for the detection of high-grade lesions with the ThinPrep Pap Test and adjunctive testing for human papillomavirus directly from the ThinPrep Pap Test vial. Seven studies focused on the ThinPrep System for non-gynecological applications.

GE Medical Systems (Waukesha, Wisconsin) said it is increasing the diagnostic utility of its Infinia Hawkeye nuclear medicine system with a new detector that enables physicians to localize disease with greater accuracy and speed. The Infinia Hawkeye combines single photon emission computed tomography and computed tomography in one system. The new 1" Elite detector with 95 photomultiplier tubes enables imaging with high- and medium-energy isotopes while preserving image quality at low energies. Separately, GE Medical Systems introduced AutoBone, the latest in its suite of clinical applications. AutoBone uncovers a vascular "roadmap" by allowing clinicians to remove the bone structure from diagnostic images. The removal of these high-density, bony barriers reveals blood vessels that are otherwise hidden in traditional imaging views, optimizing surgical pathways with more precise information to allow for less-invasive clinical procedures. AutoBone software provides automated bone removal imaging from computed tomographic angiography studies for the abdomen and lower extremities. With one click, bony structures can be removed and then restored to create the transparent roadmap.

Guidant (Indianapolis, Indiana) reported FDA approval of the Endotak Reliance G family of defibrillation leads. The product line features a proprietary covering to prevent tissue in-growth into the defibrillation coils without compromising the electrical performance of the lead. The Endotak Reliance G leads feature a covering from W.L. Gore & Associates (Flagstaff, Arizona) through an exclusive agreement between the companies. Guidant said it is the first defibrillation lead on the market to address tissue in-growth using this approach. Dr. Larry Rosenthal, investigator in the Endotak Reliance G clinical study at the University of Massachusetts Memorial Medical Center (Worcester, Massachusetts), said, "Lead removal is made even more difficult when tissue attaches to the lead. Guidant is the first company to offer a lead with covered coils that prevent tissue in-growth." Separately, Guidant reported FDA approval of the latest addition to the Insignia family of pacemakers the Insignia Ultra, designed for treatment of bradycardia. The new pacemaker includes automatic capture, which looks at every beat to see if the lower chambers of the heart contracted in response to the delivered pacing pulse from the device. If no contraction is detected, a backup pace with more energy is issued to ensure contraction. The AutoLifestyle feature is designed to automatically tailor Guidant's blended sensor technology to each patient by approximating a normal heart response for people who can't do so on their own.

iCAD (Nashua, New Hampshire) said it has received FDA approval to market its new iCAD iQ Computer-Aided Detection system. The iQ system is designed specifically for women's health centers and breast clinics that perform fewer than 20 mammography procedures per day. The FDA approval also permits use of the company's new Fulcrum digitizer in connection with its MammoReader computer-aided detection products. The iQ, simple to operate and self-training in nature, has been designed to fit within the space requirements of smaller mammography clinics and will be offered for a price of less than $70,000. iCAD also will offer its new iQ system for the early detection of breast cancer to qualifying women's health centers and mammography clinics through a simple fee-per-procedure program called ClickCAD. iCAD exhibited the iCAD iQ at the Radiology Society of North America meeting last month.

Medtronic (Minneapolis, Minnesota) reported the start of patient enrollment in its VALOR (Evaluation of the Safety and Efficacy of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) study. The prospective, non-randomized, consecutive trial will be conducted at 35 clinical sites throughout the U.S., involving about 500 patients, and will study the use of the investigational Talent Thoracic Stent Graft System in three distinct groups of patients with disease of or trauma to the thoracic aorta.

Nellcor (Pleasanton, California), part of Tyco Healthcare, said that a study presented at the October meeting of the American Society of Anesthesiologists in San Francisco, California, found the Nellcor Max-Fast Forehead Sensor provides a faster response time to hypoxia in poorly perfused patients under general anesthesia, compared with a conventional finger sensor. The researchers evaluated the response time of each sensor, simulating hypoxia and low perfusion on 18 patients under general anesthesia. The data revealed that the Max-Fast Forehead Sensor detected the initial drop in saturation and the return to 100% saturation significantly sooner than the conventional finger sensor during low perfusion.

Nikon Instruments (Melville, New York) reported the introduction of the Universal Epi-Fluorescence Reflected Light Illuminator Module for Nikon Eclipse upright microscope models. The illuminator provides superior fluorescence imaging for cutting-edge scientific research and supports all types of reflected light illumination techniques for opaque materials science, semi-conductor and metallurgical samples, the company said. An optional excitation balancer allows the user to continuously change the excitation wavelength and decide which color to emphasize during imaging of multi-stained samples. Nikon said its new Noise Terminator feature improves the S/N ratio, blocking stray light from entering the imaging light path and adversely affecting the image. The unit features removable and centerable field and aperture diaphragms and neutral density filters to provide complete control of the illumination to the specimen being observed.

Olympus (Melville, New York) introduced three stereomicroscopes that it said offer users a completely new look at stereomicroscopy, with the comfort of new eyepieces and ergonomic features, along with the largest zoom ranges in their classes. The SZ61, SZ51 and SZX7 zoom stereomicroscopes come in a variety of configurations and have an extensive series of accessories. The SZ61 offers a zoom ratio of 6.7:1; the SZ51 offers a best-in-class zoom ratio of 5:1; the SZX7 stereomicroscope features a Galilean optical system, previously restricted to more specialized bioscience research systems. The SZX7 has a zoom ratio of 7:1, which is the highest in its class.

Orthovita (Malvern, Pennsylvania) said it has received an investigational device exemption from the FDA allowing the company to begin a pivotal human clinical study to evaluate the safety and effectiveness of Cortoss Synthetic Cortical Bone Void Filler in the repair of vertebral compression fractures (VCF). Using the vertebroplasty technique, the study will assess the ability of Cortoss to provide both pain relief and improvement in function to VCF patients by providing strength and stability to fractured vertebra. Low volumes of Cortoss will be injected percutaneously through the skin into the fractured thoracic or lumbar vertebra to stabilize and restore load-bearing capability. Cortoss is a high-strength, biocompatible, self-setting composite engineered to mimic the characteristics of the body's weight-bearing structural bone. It is administered using a prefilled, unit dose disposable cartridge. Separately, Orthovita has received FDA clearance to market its prefilled Vitoss Cartridge. The company said the new device offers surgeons a more efficient way to intraoperatively administer its portfolio of Vitoss Scaffold Synthetic Cancellous Bone Void Filler products for a range of bone-repair needs. The Vitoss Cartridge provides surgeons with a new and more convenient option for sterile graft preparation by incorporating Vitoss Scaffold Standard Morsels and Vitoss Scaffold Micro Morsels within a prefilled, unit-dose, graft preparation and delivery device. The cartridge is compatible with Orthovita's line of bone marrow aspiration needles and offers surgeons a range of options to aspirate and combine Vitoss Scaffold with the patient's own bone marrow for implantation into the affected area.

Respironics (Murraysville, Pennsylvania) reported the release of its PerformaTrak Single Patient Use Full Face Mask. The PerformaTrak incorporates features such as a forehead adjustment track designed to provide enhanced comfort and fit. Other features include a dual-flap facemask cushion to provide comfort and effective leak control; new and improved head strap clips, incorporating a ball-and-socket swivel design to provide an intuitive and secure method of connecting and disconnecting the straps; an efficient entrainment valve for safety in case of ventilator failure or occlusion of the tube; and an integrated sizing gauge to make mask-fitting easier.

Smith & Nephew Endoscopy (Andover, Massachusetts) reported the launch of the 640 Image Management System, an enhanced surgical documentation system used to store, access and distribute intra-operative patient reports, and digital surgical video clips and still images. The system includes Windows 2000 compatibility, providing easier integration to a hospital's network and peripherals, such as shared printers and servers. Added functionality also includes enhanced usability through a graphical user interface and support of a touch panel input display, allowing surgeons to review images and video without losing access to the current surgical video. Multi-procedural information can now be saved to a hard disc drive and CD or exported via a hospital's computer network. For non-networked video applications, the 640 System also supports standard paper printers for hard copy documentation. With its Hermes-ready interface, the 640 Image Management System also provides surgeons with the ability to control the device through simple voice commands or via a hand-held, touch-screen pendant.

Smith & Nephew Wound Management (Largo, Florida) reported the launch of a new advanced wound management product, the Gladase brand enzymatic wound debrider. The rights to the product, which aids clinicians in treating necrotic wounds quickly and effectively, have been acquired from Stiefel Laboratories (Coral Gables, Florida). The Gladase product will become Smith & Nephew's leading enzymatic treatment in the U.S.

St. Jude Medical (St. Paul, Minnesota) reported the launch of the Angio-Seal Millennium Platform vascular closure device for sale in Japan. Joseph McCullough, president of St. Jude Medical International, said, "The impressive clinical and patient benefits provided by the Angio-Seal closure device will enable Japanese clinicians to significantly improve lab efficiencies and patient comfort."

St. Jude Medical Canada (Mississauga, Ontario) said Dr. Tirone David implanted the 20,000th Toronto Stentless Porcine Heart Valve (Toronto SPV valve) in mid-November at Toronto General Hospital (Toronto, Ontario), marking a milestone for both the device and the doctor who invented it. "Compared to artificial stents, this one should reduce the amount of stress on the valve, potentially making it more durable and improving blood circulation," David said. According to the company's recently released 10-year clinical data on the Toronto SPV valve, about 98% of patients were free from valve-replacement related deaths after one year, and almost 95% after nine years.

TheraSense (Alameda, California) released the results of its FreeStyle Navigator continuous glucose monitor home-use trial in scientific presentations for the third annual Diabetes Technology meeting in San Francisco, California. The home-use trial involved 102 subjects 60% with Type 1 diabetes and 40% with Type 2 diabetes at seven clinical sites. When the FreeStyle in vitro results were compared to the prospectively calibrated data from the continuous system, 96.3% of the data points fell in the A and B regions of the Clarke Cox Error Grid.

Tomen America (New York) and Nippon Kayaku (Tokyo) reported that the FDA has granted marketing clearance for the GlycoMark test. This blood test is cleared for the intermediate-term monitoring of glycemic control in people with diabetes. Data from a prospective clinical study conducted at Washington University (St. Louis, Missouri) was presented at the Diabetes Technology meeting. The GlycoMark test measures the level of 1,5-anhydroglucitol (1,5-AG) in human blood. 1,5-AG responds rapidly to increasing glucose levels and reflects average glucose levels over a period of a few days to two weeks, which the company said may allow patients to seek medical intervention in a timely manner, empowering patients to achieve and maintain control of their disease.

Viatronix (Stony Brook, New York), a developer of 2-D/3-D visualization software, has received FDA 510(k) clearance for its V3D-Vascular module. The V3D-Vascular module allows radiologists to examine vessels in 2-D and 3-D, fly through, view hard and soft plaque and make precise measurements. The V3D-Vascular module streamlines vascular computed tomography, magnetic resonance and 3-D reconstructed X-ray angiography examinations with a variety of tools to select and visualize entire vascular trees in seconds. The company said the technology in V3D Vascular is able to distinguish and segment poorly enhanced and small vessels throughout the body. Many vessels can be selected with just a single mouse click. V3D-Vascular also contains techniques to visually eliminate calcified plaque from 3-D views, leaving the remaining blood lumen clearly visible.

Welch Allyn Monitoring (Beaverton, Oregon) reported the introduction of the Welch Allyn Vital Signs Monitor 300 Series, a full-featured patient monitor that the company said enhances clinician productivity by providing automated vital signs before, during and after medical procedures. Featuring separate modes for neonatal, pediatric and adult patients, the monitor also incorporates Welch Allyn's SureTemp Plus electronic thermometry capabilities for quick, accurate temperatures. Push-button menu operation and large, bright display allow clinicians to easily obtain patient data for both routine assessment and continuous monitoring of vital signs.

Xilas Medical (San Antonio, Texas) reported the results of Phase II clinical trials designed to evaluate the effectiveness of its TempTouch home infrared temperature probe to reduce the incidence of diabetic foot ulcers among high-risk patients. The trial, sponsored by the National Institutes of Health (Bethesda, Maryland) through a Small Business Innovation Research grant, resulted in a significant reduction in the frequency of ulceration in people with diabetes who are neuropathic and have a prior history of foot ulcers. Patients using the device were able to identify potential foot problems at an early stage and take corrective action with their physician to avoid foot problems. The key result of this trial was that the level of ulceration was 4% for those using the TempTouch vs. 30% for those patients who did not use the device.