Radiofrequency ablation of lung tumors shown safe and effective in clinical trial
RITA Medical Systems Inc (Mountain View, Calif) presented its study results of 96 patients treated with radiofrequency ablation (RFA) for malignant lung tumors. Riccardo Lencioni, MD, professor of diagnostic and interventional radiology at the University of Pisa in Italy, presented the study results in a paper titled, Percutaneous Radiofrequency Ablation of Pulmonary Malignancies: A Prospective Multi-Center Clinical Trial, at the 89th RSNA Scientific Assembly and Annual Meeting in Chicago last November. Early results from the study suggest that CT-guided RFA provides successful local control of tumors with low morbidity and no mortality in patients with pulmonary malignancies.
Lencioni stated that the study demonstrates that RFA is a very effective alternate treatment to surgery for patients with unresectable lung tumors. The treatment offers a high success rate for local destruction of the tumors, while not precluding chemotherapy as a complementary treatment for systemic control of the disease.
Seven centers participated in the Radiofrequency Ablation of Pulmonary Tumor Response Evaluation (RAPTURE) study, designed to demonstrate the viability of RFA as an alternate or complementary treatment for patients with non–small-cell lung cancer (NSCLC) or metastases with favorable histoypes. All patients were considered unfit for surgery and had exhausted radiation and chemotherapy alternatives. Early 6-month and 12-month data shows effective local control in both primary and secondary tumors. Of the patients evaluated, 90% showed positive response to the therapy without residual tumor growth during the follow-up.
“Early results from this large, multicenter trial suggest a clear medical need for new treatment options for patients with lung cancer,” commented Joseph DeVivo, president and CEO of RITA Medical Systems. “The increasing application for CT screening for patients with risk factors will lead to a larger number of lung cancer patients worldwide being identified early in the disease state. These are the reasons we have chosen to support the application of RFA to treat primary and metastatic lung tumors.”
Patient enrollment in the RAPTURE trial was completed December 31, 2003. Patients will continue to be followed by each study center to determine long-term patient survival benefits.
Kodak to deliver global storage infrastructure for healthcare facilities
Eastman Kodak Co (Rochester, NY) and IBM (White Plains, NY) have announced that the companies will work together to make it easier and more efficient for healthcare facilities to manage the wealth of medical images and information being created in a digital world.
In response to customer demand, the two companies will offer facilities solutions that combine Kodak’s medical-imaging products and services, such as enterprise archiving and PACS systems, with IBM’s storage devices. This open, flexible software/hardware combination can help medical professionals reduce cost and improve patient care by allowing them to store, retrieve, and share large amounts of data across their enterprise. The goal is to provide doctors with on-demand access to medical images, which can ultimately improve the quality of patient care.
Specifically, IBM’s TotalStorage products will be integrated with Kodak’s DirectView Versatile Intelligent Patient Archive (VIParchive) software to provide enterprise-wide management of images and information across multiple storage devices and locations. The data management capabilities of the VIParchive extend Kodak’s abilities beyond radiology and into the healthcare IT market. With this solution, IT managers can leverage shared storage systems across multiple applications, ranging from radiology and cardiology to purchasing, inventory, payroll, and more.
IBM will supply storage infra-structures that power Kodak’s medical-imaging systems to help manage and store large volumes of patient images and accompanying information. “The challenge is storing and accessing images for radiologists and doctors with greater speed and reliability,” said Patrick Boyle, medical imaging segment executive at IBM Life Sciences.
Kodak has collaborated with IBM to certify and test IBM enterprise storage systems with its PACS as well as other healthcare IT applications. Kodak also can now offer to integrate its medical-imaging products into a customer’s existing infrastructure to help lower total cost of ownership and improve performance.
Hitachi Medical and Novation to form partnership
Hitachi Medical Systems America (Twinsburg, Ohio) announced a 3-year purchasing agreement with Novation (Irving, Texas), which is the supply company of VHA Inc and the University HealthSystem Consortium (UHC). The agreement took effect January 1, and covers the Hitachi Altaire and AIRIS II MRI systems, both products of Hitachi’s integration of clinical imaging with Open MRI patient comfort.
“The dual-source contract was awarded based on Novation’s competitive-bid process,” said Eldon Peterson, group senior VP for Novation. “Our diagnostic imaging council, made up of representatives from member hospitals, supported the decision based upon financial and nonfinancial criteria.”
Novation was established in 1998 through a combination of the supply programs of VHA and UHC, two national healthcare alliances. The company serves the purchasing needs of more than 2,300 members and affiliates of VHA and UHC. In 2002, VHA and UHC members purchased nearly $20 billion in supplies through Novation contracts.
Agfa and R2 Technology team up to distribute CAD systems
Agfa (Mortsel, Belgium) and R2 Technology (Sunnyvale, Calif) have signed a memorandum of understanding regarding the distribution of R2’s ImageChecker CAD system in the Agfa digital mammography solutions. CAD technology has been shown to magnify breast cancers identified on mammograms by 10% to 20% while minimizing the false negative readings.
“We see an increased sensitivity for early detection, after only a couple months of using CAD,” said Dr Elisabeth Winters, radiologist at the Woman’s Hospital (Baton Rouge, La). “Having a second pair of eyes to look at the image at the end of a busy day, when human eyes are distracted, is certainly worth it.”
Mike Klein, CEO and president of R2 Technology, considers the newly announced cooperation to be another milestone in the field of early breast cancer detection. “We believe that the combination of Agfa and R2’s suite of digital mammography technologies will result in an intelligent CAD approach, which will push early breast cancer detection another step ahead,” he said.
Flo Healthcare Solutions acquires wireless mobile computing business
Flo Healthcare Solutions LLC (Norcross, Ga) recently announced the acquisition of the healthcare division of EMS Wireless, a division of EMS Technologies (Binghamton, NY), a leading provider of mobile devices and Wi-Fi–related products.
The acquisition follows recent developments in the medical-device market, including growth in the adoption of EMS’s patented Flo mobile workstation. The acquired company, now called FHS, will continue to operate in the same Norcross, Ga, facility.
Partnership initiated to improve computer understanding of medical device data
ECRI (Plymouth Meeting, Pa), a nonprofit health services research agency, recently announced its agreement with Apelon Inc (Ridgefield, Conn) to use its Terminology Development Environment (TDE) modeling tool for ongoing development of ECRI’s Universal Medical Device Nomenclature System (UMDNS)—a standardized international nomenclature and computer coding system for medical devices. ECRI professionals will use the TDE to improve the structure and consistency of UMDNS and to enhance its interconnectivity with other standard vocabularies. These additions will support the advanced clinical application of UMDNS and make the nomenclature easier to integrate with a variety of healthcare information systems.
UMDNS, the most universally accepted medical-device coding and classification system, has recently been recommended by the Committee on Data Standards for Patient Safety of the Institute of Medicine as one of the core terminologies for the electronic health record. UMDNS currently has more than 5,000 users in 100 countries, including hospitals, nonprofit organizations, government agencies, device manufacturers, and e-commerce companies. The continually updated controlled nomenclature includes 6,500-plus preferred terms and nearly 7,000 additional entry terms for medical devices and materials, clinical laboratory equipment and in vitro diagnostics, disposables and supplies, selected hospital furniture, casework, and clinical equipment testing systems and instruments.
“We look forward to applying Apelon’s advanced technology to the development of UMDNS. It will greatly enhance our ability to keep our terminology up to date with the rapid evolution of medical devices,” said Vivian Coates, ECRI’s VP of information services and technology assessment. “We believe the TDE will enable us to more rapidly and efficiently update UMDNS with these changes and make it easier for our customers to use UMDNS in their applications.”
Varian Medical and Amerinet renew supply agreement
Varian Medical Systems Inc (Palo Alto, Calif) and Amerinet Inc (Ann Arbor, Mich) have renewed a preferred pricing agreement to supply Amerinet members with advanced systems for treating cancer with radiotherapy. The contract covers Varian’s equipment and software for radiation therapy, including SmartBeam IMRT (intensified modulated radiation therapy), a highly precise form of radiation therapy that targets cancer cells while minimizing the exposure of nearby healthy tissue.
The agreement makes available Varian’s full range of products, including the Clinac EX Platinum linear accelerator, Acuity treatment simulator, multi-leaf collimators, and other accessories for radiation therapy. Varian’s products also include software for planning treatment and managing patient information, brachytherapy systems, and medical-imaging systems.
Olympus honored by Frost & Sullivan for technology innovation
The EndoEYE family of surgical videoscopes from Olympus (Melville, NY) has been awarded the 2003 Technology Innovation Award for minimally invasive surgery instruments and laparoscopes by Frost & Sullivan, an international strategic marketing, consulting, and training firm that tracks advances in various technological areas.
In presenting this award, Frost & Sullivan called the EndoEYE videoscopes “the newest solution in imaging [for placing] the miniaturized camera chip in the distal, or operating field, end of the scope for advanced digital image processing and output.” Frost & Sullivan also noted, “With patient health and safety as its number one priority, Olympus has integrated advanced technology and expertise in optics, digital imaging, and precision engineering to develop the instruments needed for minimally invasive surgical procedures.”
The EndoEYE surgical videoscopes, which are powered by the VISERA multi-specialty, digital-imaging platform, includes fully autoclavable videoscopes in both 5mm and 10mm versions, available in both straight viewing and 30? angle viewing. In addition, the LTF-V3 deflectable tip EndoEYE surgical videoscope allows for unmatched maneuverability and viewing capabilities with its four-way angulation system.
According to Frost & Sullivan, “Other EndoEYE advances include a one-piece design, eliminating the need for fragile rod/lens assembly, and the first fully autoclavable design from end to end, [giving this instrument] more durability, eliminating costly rod/lens repairs, and dramatically reducing operating room set up time compared to conventional rigid scopes.”
Receiving a Frost & Sullivan Tech-nology Innovation Award requires the analyst team to examine criteria, including technology innovation contrasted against competitors, R&D expenditures, new product/process introduction, price premium, first to market, adoption rate, and penetration rate. The analyst team tracks emerging and existing technologies by interviewing major market participants and by conducting extensive secondary research in order to determine industry and product ranking.
Entela QRD grants ISO 9000, 14000 certifications
Entela Inc’s (Grand Rapids, Mich) Quality System Registration Division (QSRD), an accredited third-party quality system registrar, recently granted registration certificates to five US facilities. The facilities’ quality management systems were assessed and found to be compliant with the ISO 9000 quality standards, QS-9000 automotive requirements, Tooling and Equipment Supplement (TE Supplement), and/or the ISO 14000 environmental management standards requirements. The companies include:
• Clarion Technologies (Greenville, Mich) ISO 14001;
• Datum Industries LLC (Kentwood, Mich) ISO 9001:2000;
• Franklin Metal Tracking (Lake Odessa, Mich) ISO 9001:2000;
• Modern Plastics Corp (Coloma, Mich) ISO 14001; and
• Proos Manufacturing Inc (Grand Rapids, Mich) ISO 9001:2000.
In order to qualify for the rating, companies must undergo a rigorous audit of their policies and procedures, operations, management, and personnel to achieve registration to these standards. Regularly scheduled surveillance audits are conducted to ensure continued conformance to industry standards. Entela QSRD provides global conformity assessment services to international, North American, and European standards; engineering services; failure-mode verification testing and materials; product and systems testing; and failure analysis.
Cedara and Alion to develop life-saving technology for military emergencies
Cadara Software Corp (Mississauga, Ontario), an independent developer of medical software technologies for the global healthcare market, has signed a development agreement with Alion Science and Technology (McLean, Va) to supply the US military with ultrasound-guided surgical technology that will reduce combat fatalities. Although initially targeted for military use, the new technology ultimately could be used in civilian emergency services to prolong the survival of patients with stroke, heart attack, and other traumatic injuries.
Under the terms of the agreement, Cedara will provide its imaging software to integrate with portable ultrasound equipment. Cedara’s software will display 3-D images of critical anatomy and provide essential guidance in performing life-saving surgery. The medical software, as part of Alion’s solution, will enable an otherwise difficult procedure to be performed quickly and safely by medically trained personnel. The introduction of this new technology is expected to improve soldiers’ survival rates.
According to Cedara, today’s field medics often have mere minutes to deal with critical combat injuries. Alion’s new technique will use suspended animation to protect vital organs from the dangers of oxygen depletion, giving medics significantly more time to stabilize and transport injured soldiers to a properly equipped medical center. Alion’s solution will use Cedara’s ultrasound navigation software to scan the patient’s anatomy into a computer, which will then guide the field medic through the surgical intervention. The technique will involve puncturing the patient’s chest and positioning a special Alion device with millimeter accuracy. The complete solution will compress the time needed to identify the source of trauma, so medical personnel can act more quickly and with better information.
Cedara and Alion will work with the Safar Center for Resuscitation Research at the University of Pittsburgh, which pioneered therapeutic hypothermia for traumatic shock and paved the way for initial human trials.
NYU Medical Center first to install new MR technology
Screen shots from the new Siemens MAGNETOM Avanto 1.5 Tesla MR system recently installed at New York University.
Siemens Medical Solutions (Malvern, Pa) recently announced the first installation of the company’s MAGNETOM Avanto—the newest 1.5 Tesla MR system and the first product to incorporate Siemens Total Imaging Matrix (TIM) technology—at New York University’s NYU Medical Center. TIM is the first whole-body surface coil concept to seamlessly combine up to 76 coil elements and 32 RF channels.
“The MAGNETOM Avanto symbolizes a new era of MR image quality, enabling high-resolution, full-body images in a shorter acquisition time,” said Heinrich Kolem, president of the MR division of Siemens Medical Solutions.
The MAGNETOM Avanto offers seamless metastasis evaluation, whole CNS imaging, and visualization of vascular diseases. It also features Siemens iPAT (integrated parallel acquisition technique) that provides fast image acquisition with parallel imaging in all dimensions, including head to toe, front to back, and side to side. The systems’ Phoenix software allows clinicians to transfer protocol for medical images from a CD, making it possible to initiate a scan directly from the image. Additionally, the system allows more audio comfort due to a noise reduction of 97%.
NYU Medical Center completed its Avanto installation in late November 2003. Since the integration of the new equipment, the Center is expecting to achieve specialized images, including whole-body imaging for vascular and musculoskeletal disorders and improved anatomic and functional imaging in the heart, lungs, abdomen, and vasculature.
“The Avanto is going to greatly impact our ability to diagnose and treat patients in a more timely and comfortable manner” said Dr Vivian Lee, associate professor and vice chair of research in the NYU Medical Center’s Department of Radiology. “Because we won’t have to change coils on the patients, we can obtain accurate, full-body examinations more quickly, and with less hassle and stress to our patients. The studies will be more comfortable for patients in [two] ways. First, the system allows feet-first examinations, which greatly decreases anxiety for patients who are uncomfortable in small spaces. And second, the new design system will mean a much quieter examination.”
On the Move
Craig Davenport has been named CEO of Endocare Inc (Irvine, Calif). He has served for more than 3 decades as an executive in the healthcare industry, and recently as an organizational consultant to Endocare, reporting directly to its board of directors. Davenport assumes the CEO position vacated by the resignation of Paul Mikus in April 2003.
Robert Ahlman
NovaRad (American Fork, Utah) recently announced the appointment of Robert Ahlman as the company’s VP of sales and marketing. Ahlman is responsible for leading NovaRad’s national sales force and contributing to the company’s marketing strategies. He brings with him more than 20 years of experience in product and system sales to the position. During Ahlman’s career, he has held managing sales positions at Iomega Corp.
Debiotech SA (Lausanne, Switzerland) recently announced the subdevelopment of SMC-Swiss Medical Care as its own privately held company. The company appointed Larry Minix as CEO of the new company. Minix has spent more than 30 years in the global healthcare industry, alternating in sales, marketing, and general management roles. Most recently, he served as general manager of nonhospital Tyco Healthcare Group in Europe, the Middle East, and Africa.
Swiss Medical Care also announced the appointment of Dr Michael Weissig to the staff position of director of marketing and sales for Europe, the Middle East, and Africa. Weissig has been working in the imaging environment for more than 10 years. He is an engineer by profession with a doctoral degree in biomedical equipment and technology. Prior to joining Swiss Medical Care, Weissig was Mallinckrodt Imaging’s business director for Liebel-Flarsheim products.
American Health Holding has moved its corporate headquarters to a 32,000-square-foot space in Worthington, Ohio, a suburb of Columbus. President and CEO Michael Reidelbach said that the new location was chosen primarily because of its room for expansion. American Health Holding can now be contacted at 100 W Old Wilson Bridge Rd, 3rd Fl, Worthington, OH 43085. The company’s Web address (www.ahhinc.com) stays the same.
