FDA Approved: System Released for Treating Barrett?s Esophagus
Site Sighting
Running the Numbers
FDA Approved: Well Chamber Measures Dosage from 26 Sources
FDA Approved: Ablation System Receives FDA Nod for Treating Nonresectable Tumors
New Patient Book on Radiation Therapy from ASTRO
Lunar Develops Investigational Concept for CyberKnife System
RITA Medical Gains US Distribution Rights to LC Bead Embolization Product
FDA and C-Path Announce Predictive Safety Testing Consortium
FDA Approved: System Released for Treating Barrett?s Esophagus
As awareness of a condition rises, so do the options for treating it. B?RRX Medical Inc (Sunnyvale, Calif) recently attained FDA clearance for its HALO90 system, a balloon-based system for ablating tissue associated with Barrett’s Esophagus.
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| The HALO90 system can be used in simple outpatient procedures to ablate damaged esophageal tissue. |
Until recently, Barrett’s Esophagus was known only because of its bookends. Caused by gastroesophageal reflux disease (GERD) and often a precursor to esophageal adenocarcinoma, the condition seemed to be a step along the path from heartburn to cancer. But a Swedish study published in Gastroenterology1 suggests that Barrett’s Esophagus is more widespread than most people think. If the Swedish and American populations are analogous in the degree to which they’re affected, a full 3 million US residents could be suffering from the disease.
The Swedish researchers also found that 40% of patients studied showed no symptoms of GERD and, thus, would never be screened for Barrett’s Esophagus under current protocol. But treating the condition early has the potential to save thousands of lives.
The HALO90 system—now cleared by the FDA—treats Barrett’s Esophagus before it becomes cancer. The device is designed to be used both independently of and along with the HALO360 system, already on the market. The HALO360 is designed to ablate larger areas of damaged esophageal tissue; HALO90 fills in the gaps left behind with a smaller range and increased precision.
An endoscope tipped by a small electrode, the HALO90 can be used in simple, cost-efficient outpatient procedures—in coordination with the imaging technology necessary to navigate the device safely to the damaged tissue.
Reference
- Ronkainen J, Aro P, Storskrubb T, et al. Prevalence of Barrett’s esophagus in the general population: an endoscopic study. Gastroenterol. 2005;129(6):1825?1831.
Site Sighting
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| www.varian.com/vss/ |
To serve as a resource for clinicians and others interested in radiosurgery, Varian Medical Systems (Palo Alto, Calif) has launched a new Web site about the company’s solutions for delivering noninvasive neurosurgery. The site features information about Varian’s Triology technology for image-guided radiosurgery as well as the treatment process. Also online are simulated case models for treating such conditions as acoustic schwannoma, arteriovenous malformation, multiple brain metastases, pituitary adenoma, and more.
Running the Numbers
20,000 is the approximate number of radiofrequency ablations of the liver that have been performed in the United States since the procedure?s beginning in the mid-1990s, according to Damian Dupuy, MD, professor of diagnostic imaging at Brown Medical School (Providence, RI) and director of tumor ablation at Rhode Island Hospital.
FDA Approved: Well Chamber Measures Dosage from 26 Sources
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| The HDR 1000 Plus Well Chamber from Standard Imaging can now accommodate Xoft?s miniature x-ray sources. |
As unpredictable as radioactive pharmaceuticals can be, an effective and accurate method for measuring how much radiation that radioactive seeds emit is vital to the success of brachytherapy. The FDA has cleared an upgraded device, the HDR 1000 Plus Well Chamber from Standard Imaging Inc (Middleton, Wis), which has been redesigned to measure radiation from x-ray sources, as well as high-dose-rate (HDR), low-dose-rate, and intravascular sources.
The HDR 1000 Plus Well Chamber checks the prescribed dosage that a patient is set to receive from the radioactive isotopes used in seed implantation. This technology already has been used to minimize the amount of exposure to radiation that a patient faces; in some cases, internal radiation now can be treated as an outpatient procedure.
Although the HDR 1000 Plus originally was designed for HDR measurements, it acts with the same precision on 26 types of sources, including low dose rate, intravascular, and x-ray. The redesign was prompted to accommodate a miniature x-ray sources new to the market from Xoft Inc (Fremont, Calif).
FDA Approved: Ablation System Receives FDA Nod for Treating Nonresectable Tumors
Radiofrequency (RF) ablation, a once-obscure procedure, is taking another step toward the mainstream, with the FDA approval of the Cool-tip RF system for the ablation of nonresectable liver tumors.
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| The Cool-tip RF uses radiofrequency waves to create heat at the end of its electrode needle, destroying tumors from the inside out. |
Ablation technology has been in wide use since the 1990s, but the FDA approval for the Cool-tip RF system, from Valleylab (Boulder, Colo)—a division of Tyco Healthcare Group LP—is a milestone in that the technology has been approved for use on hepatic tumors, not just “tissue/liver lesions.”
“Interventional oncologists have been ablating liver tumors since the mid-’90s with the Cool-tip RF ablation system,” said Damian Dupuy, MD, professor of diagnostic imaging at Brown Medical School (Providence) and director of tumor ablation at Rhode Island Hospital. “The continued acceptance of this procedure is a testament to the technology and the hard work that interventional oncologists have done over the last decade.”
Specifically designed for use on hepatic tissue, the Cool-tip RF system destroys lesions and tumors on contact using RF waves to generate heat in an electrode needle. As the system employs water to cool itself internally, energy accumulates at the needle’s tip and, on demand, sparks the heat necessary to ablate a tumor from the inside out—without damaging any of a patient’s healthy tissue. This process—which, in many cases, can be repeated as often as is necessary to ablate the tumor completely—is noninvasive, providing greater patient comfort.
Ablation is a particularly valuable technique when dealing with cancers of the liver and other soft tissue. When removal of too much tissue could be dangerous, or when tissue could be damaged or destroyed during a procedure, ablation provides a noninvasive alternative.
Both CT and ultrasound have been used in the past to facilitate ablation procedures.
New Patient Book on Radiation Therapy from ASTRO
A new booklet geared toward Spanish-speaking patients and families is available from the American Society for Therapeutic Radiology and Oncology (ASTRO of Fairfax, Va). Radiation Therapy for Cancer: Facts to Help Patients Make an Informed Decision—now translated into Spanish—is a treatment guide to help patients and their families understand how radiation therapy works to treat cancer. It also provides information on the various members of the treatment team and explains the differences between the many types of radiation therapy. The booklet—as well as 14 other patient-dedicated brochures—can be downloaded for free by visiting www.astro.org/patient/treatment_information/.
Lunar Develops Investigational Concept for CyberKnife System
Lunar Design (San Francisco), a product-development and design firm, has announced a next-generation design for the CyberKnife Robotic Radiosurgery System from Accuray Inc (Sunnyvale, Calif).
Accuray’s CyberKnife system combines image guidance and computer-controlled robotics to continuously track, detect, and correct for tumor and patient movement throughout treatment, enabling the CyberKnife to treat tumors anywhere in the body with submillimeter accuracy. The active tracking and high precision shorten treatment times and eliminate patient discomfort of invasively attached head and body frames used in traditional radiosurgery.
“Our goal throughout the development of this system for Accuray has been to create a solution that benefits the technologist, patient, and hospital—and to communicate those benefits through remarkably clear design,” said Robert Howard, director of Lunar Design’s medical engineering and design practice.
Lunar conducted a range of interviews and on-site studies with patients and their advocates, CyberKnife operators, administrators, and more. From this research, Lunar constructed a well-informed grand vision for the CyberKinfe supported by malleable guidelines for site architects to follow.
Mike Saracen, director of product management at Accuray, said, “The team at Lunar was eager to tackle the challenges of this project and succeeded in overcoming ergonomic, clinical, and engineering hurdles.”
RITA Medical Gains US Distribution Rights to LC Bead Embolization Product
RITA Medical Systems Inc (Fremont, Calif) has partnered with Biocompatibles International plc (Farnham, UK) in an exclusive 3-year supply and distribution agreement. RITA, which focuses on cancer therapy, will market and distribute Biocompatibles’ LC Bead embolization product in the United States and Canada.
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| The LC Bead blocks blood flow to a tumor, rendering it more susceptible to other treatments (Click image for larger view) |
Designed for the minimally invasive treatment of hypervascular tumors, the LC Bead microspheres work by blocking the blood flow of vessels into which they’ve been injected, thereby starving a tumor and causing it to shrink over time. LC Bead microspheres often are used in conjunction with radiofrequency (RF) ablation, another minimally invasive cancer therapy procedure.
According to RITA, the total US and Canadian market for all embolization products could peak at $50 million this year. Embolization, like RF ablation, is a particularly useful procedure when dealing with cancers of the liver, where tissues are soft and sensitive to any damage.
The LC Bead works as the embolic component to transarterial chemo-embolization, which has been shown in clinical trials to reduce the size of liver tumors.
FDA and C-Path Announce Predictive Safety Testing Consortium
The FDA (Rockville, Md) and the Critical Path Institute (C-Path of Tucson, Ariz) have announced the formation of the Predictive Safety Testing Consortium between C-Path and five of the United States’ largest pharmaceutical companies to share internally developed laboratory methods to predict the safety of new treatments before they are tested in humans. Although not a member of the partnership, the FDA will assist in an advisory capacity. This sharing of potential early indicators of clinical safety could streamline the cost and time of preclinical drug safety evaluation and better inform the use of “personalized medicine.” The consortium was announced at a press conference detailing the release of the Critical Path Opportunities List—76 initial research priorities that, if accomplished, will modernize the drug development process by 2010 and help get new medical discoveries to Americans faster and at a lower cost.
“The power of public?private partnerships is vital to accomplish the tasks set forth in the Critical Path Opportunities List,” said Mike Leavitt, Health and Human Services Secretary. “The Predictive Safety Testing Consortium is a prime example of a collaborative culture that must exist to modernize the development process. The collective sharing of scientific information and research across the entire health care community is crucial to igniting the medical innovation required to keep pace with biomedical research.”
The Critical Path Opportunities Report is organized into six broad topic areas: development of biomarkers, clinical trial designs, bioinformatics, manufacturing, public health needs, and pediatrics. The FDA’s outreach efforts uncovered a consensus that the two most important areas for improving medical product development are developing biomarkers and streamlining clinical trials.
“The approach to diagnostics and therapeutics represented by the FDA, CMS, and the NCI’s Oncology Biomarker Qualification Initiative [OBQI] is integral to efficiencies in health care delivery, as well as the critical path for drug development, and is completely in line with our own approach,” said Richard Frank, vice president of medical and clinical strategy at GE Healthcare (Waukesha, Wis). “In fact, we’ve created a business called Pharma Enterprise, which is dedicated to working with pharmaceutical companies in this way. The future of health care is an ‘early health’ model, when early detection enables early intervention. The next step for diagnostics is analogous to the biomarker model in drug development; early measures of treatment benefit enable refinements in the treatment regimen and better outcomes. Better outcomes will reduce health care costs, hence the involvement of CMS in the OBQI.”
