FDA Notice Casts Pall on Spine Procedures
Vertebroplasty, a procedure performed by interventional radiologists that has reduced pain and increased mobility among selected spinal fracture patients, was given a big thumbs-up in a multicenter study published in the February issue of Radiology. In stark contrast to that endorsement, the procedure has come under fire from the US Food and Drug Administration, which issued a notice in April cautioning against the use of the bone cement involved in vertebroplasty and a similar procedure performed by orthopedic surgeons, kyphoplasty.
Interventional radiologists perform vertebroplasty with an x-ray-guided needle that delivers polymethylmethacrylate (PMMA), a bone cement, to fill in and stabilize a broken bone. (The cement has been used for almost 40 years.) A team of researchers led by Avery J. Evans, MD, assistant clinical professor of radiology and neurosurgery at the University of South Florida, conducted the retrospective study published in Radiology.
The study of 245 patients who underwent percutaneous PMMA vertebroplasty at seven US hospitals between 1996 and 1999 found the procedure to be safe and effective. Following the procedure, the patients’ self-reported mean pain score decreased from 8.9 to 3.4 on a 10-point scale. Approximately 72% of the patients had difficulty walking prior to treatment, compared with 28% afterward. The ability to perform activities of daily living also improved following the procedure.
However, the FDA notice cautioned that off-label use of bone cements to treat compression spine fractures can lead to complications including serious injuries and death. The alert concerns the use of PMMA cements, which have never been cleared by the FDA for use in vertebroplasty or kyphoplasty. The FDA says it has received reports of pulmonary embolism, respiratory and cardiac failure, abdominal intrusions, and deaths in patients undergoing the procedures.
“Issuing a warning like this is routine for us when we have seen serious adverse effects, even if it’s a very small amount of cases,” says Laura Alonge, a biologist on the FDA’s issues management staff. “We just want physicians and patients to both be aware of those instances.” She says the agency looked at data from its medical devices reporting database over a 5-year period.
Diane Schnitzler, communications director for the Society of Interventional Radiology, considers the FDA warning to be inaccurate. “The procedure has been very successful, in our experience,” she says. “We don’t have any real concerns with it. I think it’s just a matter of getting the FDA the right information.” Schnitzler adds that there is a perception problem at work as well. “With that warning, the FDA was lumping vertebroplasty in with kyphoplasty, which is unfair.”
But the FDA’s Alonge says “both procedures had a similar number of adverse effects reported.”
Schnitzler says representatives from her organization recently made a trip to the FDA office to make a presentation. The society also recently put out a press release touting the positive effects of vertebroplasty.
However, the University of South Florida study’s authors note that, although PMMA’s safety record is well-established, “the potential for adverse effects must be considered.” They cite the symptomatic complication rate for patients in the series as 4.9%, with previous findings suggesting that the rate of clinical complication is 5% to 7% for patients with osteoporosis who have had vertebroplasty.
But those mostly consisted of minor complications such as rib fractures and temporary radicular pain, the authors say, adding that “major complications such as permanent neurologic injury or serious pulmonary embolism are rare.”
ACR Endorses ASRT’s Radiologist Assistant
The American College of Radiology (ACR), reston, Va, recently endorsed the American Society of Radiologic Technologists’ (ASRT), Albuquerque, NM, proposed roles and responsibilities for a new radiologist assistant (RA) position. The ACR’s acceptance of the proposed roles was an important step forward for the evolving position. “We thought it was very important for radiologists to buy into this, if it had any chance of real success to become a national program,” says Lynn May, ASRT’s CEO.
According to May, ASRT predicts a 30% shortage of radiographers in the next 10 years. The RA designation is expected to act as a career ladder, retention, and recruitment tool. Under the proposed roles and responsibilities outlined by the ASRT, the RA will do no interpretation and will make no observations to anyone other than the supervising radiologist. Duties will include obtaining consent for and injecting agents, taking clinical histories, performing pre- and post-procedure evaluations of patients undergoing invasive procedures, and communicating the radiologist’s report to the referring physician.
The idea of a radiology physician extender is not new. Radiology practitioner assistants (RPAs) have been around for several years, and their duties, says May, are fundamentally the same as those proposed for the RA. The essential difference is that the RA will have a baccalaureate degree, while the RPA is not required to have a degree.
The first class of RAs enters California’s Loma Linda University this fall. Loma Linda University, Midwestern State University, the University of North Carolina at Chapel Hill, and the University of Medicine and Dentistry of New Jersey all received grant money from the ASRT to set up their programs.
Like all solutions, it could take up to 10 years to have enough RAs in the field to make an impact, but May is confident that they will be a benefit. “I think it will improve the radiology workload, and hopefully ease patient access,” he says.
For further information, log onto www.asrt.org .
Continued Growth of MRI Scanner Sales Predicted
|Figure. In 2002, the US MRI scanner market was estimated at $1.46 billion; it is expected to reach $1.97 billion by 2009. Source: Frost & Sullivan.|
A recent study by Frost & Sullivan showed that the total US MRI scanner market generated approximately $1.46 billion in 2002, representing an annual growth rate of 20.8%. Revenues are expected to pass $1.97 billion in 2009, translating into a compound annual growth rate of 4.4%. Drivers contributing to this growth:
The adoption of higher field scanners by the end-user group, a trend that is transforming the market as hospitals and imaging centers adopt these solutions to attract the most customers;
The development of new applications that are expected to enhance the adoption of the higher field scanners now being introduced. Technologies such as parallel imaging have allowed the migration of applications from the high field closed market to the mid-field open market;
The development of niche markets in order to expand the customer base, including specialty physician practices and surgical groups within larger hospitals.
CPS Innovations, Knoxville, Tenn, has announced the introduction of a 16-slice LSO PET/CT to the University of Tennessee Graduate School of Medicine’s Cancer Imaging and Tracer Development Research Program, under the direction of David Townsend, MD. The system is the first completed installation of the scanner…Emageon, a provider of enterprise solutions for medical image storage, distribution, and work flow, and UltraVisual Medical Systems, a developer of enterprise medical image visualization software, have merged operations. The merged company headquarters will be in Birmingham, Ala, with visualization software development continuing in Madison, Wis…Center for Diagnostic Imaging Inc, Milwaukee, is celebrating its 10th anniversary of providing subspecialty imaging services and interpretations from 23 freestanding imaging centers in six states…Rorke Data, San Jose, Calif, has announced it will distribute a line of NetFORCE? storage solutions from Procom, Irvine, Calif. The partnership will provide hospitals, medical laboratories, and research facilities with secure, scalable, and fault-tolerant data storage solutions…Shimadzu Medical Systems, Torrance, Calif, and MTS-Delft USA, Aurora, Ohio, have reached a joint marketing agreement that enables Shimadzu dealers to offer MTS-Delft’s SUREFYRE digital modality archiver fully integrated with Shimadzu digital imaging systems. Shimadzu systems that will feature this technology include digital R/F, angiographic and cardiac x-ray, and CT. In addition, Shimadzu and Viatronix Inc, Long Island, NY, have announced a strategic relationship for the development of a custom visualization module for Shimadzu’s 3D Angio system, to be integrated into Viatronix’s V3D Explorer…Richardson Electronics, LaFox, Ill, has introduced a new PACS-capable, DICOM-compliant medical display solution for nondiagnostic applications. The ViewMedX? RTP4000 is an integrated 40-inch diagonal LCD display solution for nonclinical review of medical images for purposes of instructing or presenting. In addition, Richardson has announced the addition of the Siemens 2 MP grayscale flat panel display to its offering. Richardson has also announced an agreement with IBM to deliver integrated workstation and display solutions to the medical imaging market. Specifically, IBM will supply Richardson with the Medical Assessment Workstation…VIDAR Systems Corp, Herndon, Va, has signed an agreement with IDX Systems Corp to include VIDAR’s DiagnosticPRO? and SIERRA? film digitizers in their specialty work-flow solutions, IDX Imagecast?. The VIDAR solutions will complement IDX’s advanced work-flow and image distribution technologies. The company also announced that Merge eFilm has utilized DiagnosticPRO and SIERRA plus products with Merge’s FUSION Server? solution. In addition, VIDAR announced that DR Systems has chosen the same two products for use in DR’s filmless computerized medical image and information management systems…Agfa Healthcare has announced the following consolidation moves: R&D will be consolidated in Waterloo, Ontario, and Mortsel, Belgium; the HealthCare Equipment Repair US department will be consolidated in Atlanta; and operations at the Glasgow, Del, facility are scheduled to close at the end of 2003…Eastman Kodak Co, Rochester, NY, announced the donation of a family of patents to McLean Hospital, Boston, for the development of new diagnostic technology for attention deficit hyperactivity disorder (ADHD). Kodak’s ADHD Rapid Check technology is being designed to lead to a new process for the objective screening of ADHD…Guidant, an Indianapolis-based medical device maker, announced that EndoVascular Technologies, one of its subsidiaries, will plead guilty to 10 felony counts in relation to its Ancure Endograft device used to treat abdominal aortic aneurysms, in addition to pulling the device off the market. Guidant was also recently ordered to pay $425 million to Johnson & Johnson for infringing on patents related to cardiac stents…ETS-Lindgren, St Louis, has received fire-rated certification to stamp its own lumber and frames in-house, which will streamline the production process and satisfy strict building codes for hospitals and clinics…Research Systems Inc (RSI), Boulder, Colo, announced that it will provide a new, free interactive data language (IDL) distribution platform with the July release of IDL 6.0…Imaging Dynamics Co (IDC), Calgary, Alberta, and Garden State Imaging Inc (GSI) have announced a joint distribution agreement for the sale of the Xplorer 1700? direct digital radiography system…StorCOMM Inc, Jacksonville, Fla, and InSiteOne Inc, Wallingford, Conn, have announced a strategic alliance to provide a holistic solution to meet modern requirements in digital radiology and PACS. In addition, InSiteOne has announced a new promotion with Konica Medical Imaging, Wayne, NJ. Through the promotion, qualified customers receive free use of a Konica Xpress CR system from InSiteOne…MDS Nordion, Vancouver, Canada, has announced the start of commercial production at its TR-30-2 cyclotron in Vancouver, authorized by the Canadian Nuclear Safety Commission for production of medical isotopes. The facility will meet the current demand for radioisotopes such as iodine 123, palladium 103, thallium 201, and indium 111…InSight Health Services Corp, Lake Forest, Calif, announced that a wholly owned subsidiary of the company has entered into a definitive asset purchase agreement to buy a majority of the assets of the mobile imaging business owned by CDL Medical Technologies Inc, Wexford, Pa… Misys Healthcare Systems, Tucson, Ariz, has signed an asset purchase agreement with Per-Se Technologies Inc to acquire the Computer- ized Patient Record/Computerized Physician Order Entry product line currently marketed as Patient1?.
|Robert E. Schaaf, MD|
James H. Thrall, MD, chairman of radiology, Massachusetts General Hospital, and professor, Harvard Medical School, Boston, has been named the new president of the American Roentgen Ray Society (ARRS) for 2003-2004. Thrall is the founder and series editor for the Requisites in Radiology series of introductory textbooks. Official journal of ARRS,The American Journal of Roentgenology, has named Robert J. Stanley, MD, its new editor-in-chief. Stanley will be based out of the University of Alabama at Birmingham, where he will continue to do clinical work. He succeeds longtime editor Lee F. Rogers, MD…Robert E. Schaaf, MD, has joined the Decisions in Axis Imaging News editorial advisory board. Schaaf is president/managing partner of Wake Radiology, Raleigh, NC. He is also on the boards of Medical Mutual Insurance Co and the North Carolina Red Cross. He graduated from Tufts Medical School in 1976, finished his residency at Duke University in 1980, and was formerly on the clinical adjunct faculties of the Duke and University of North Carolina medical schools…Rex Harmon, vice president of global marketing and PR manager, Swissray, Elizabeth, NJ, has received the IN-AWE award for medical device market- ing excellence from the Medical Marketing Association…SourceOne Healthcare Technologies Inc, Cleveland, has named Brett Himes as its senior vice president and CFO. Himes will be responsible for directing and supervising SourceOne’s financial planning, strategy, and record keeping. In addition, the company has named Robert J. White as its senior vice president of sales and marketing…The Society for Computer Applications in Radiology (SCAR) has named Janice Honeyman-Buck, PhD, the new editor-in-chief of the Journal of Digital Imaging (JDI), the Society’s official publication. For the past decade, Honeyman-Buck has been the leader of the Shands Healthcare Inc Enterprise PACS development and deployment. She also previously served as director of the School of Nuclear Medicine Technology and of Medical Imaging at the University of Virginia…Eastman Kodak’s Health Imaging Group, Rochester, NY, announced that Atul Minocha, its chief marketing officer, will succeed Phillip Berman, MD, as leader of AuntMinnie.com, an online radiology resource. Minocha joined Kodak in 2000, when it acquired the Web site. AuntMinnie.com will remain an autonomous unit within Kodak, and will take direction and guidance from Minocha. In an additional move, Kodak also announced that Jonathan J. Tweed has been appointed director, Worldwide Original Equipment Manufacturers Business and vice president of the Health Imaging Group…Konica Medical Imaging, Wayne, NJ, has announced that Wayne Thompson, president and COO, will be resigning his position to become president and CEO of Joint Purchasing Corp (JPC), a non profit health services organization. The company has also announced that Terry Hasegawa has been appointed president of Konica, having most recently served as vice president/treasurer of the company…Alliance Medical Corp, Phoenix, has hired Ron Clark as director of the company’s R&D department.