The Cancer Therapy & Research Center (CTRC; San Antonio, Texas), through its medical physics team, has completed what it said may be a milestone in radiation by being the first cancer center to overlay high-resolution positron emission tomography (PET) onto Marconi Medical's (Highland Heights, Ohio) computed tomography (CT) planning images for use in Intensity Modulated RadioTherapy (IMRT) from Nomos (Sewickley, Pennsylvania).
CTRC medical physicists have been working with CTI PET Systems (CPS; Knoxville, Tennessee), manufacturer of the ECAT HR Plus high-resolution PET scanner, to fuse together these technologies. The effort is being led by James Hevezi, PhD, director of medical physics at CTRC, and his associate director, Bill Salter, PhD. The team has overlaid PET images onto Nomos' Corvus CT image planning system, saying this makes possible the targeting of lesions that are only visible on a PET image. Research is under way to explore the potential of targeting such lesions with the Nomos Peacock MIMiC system to conformally cover the PET displayed targets 3-dimensionally.
"We have successfully overlaid these PET images onto our conventional CT planning images," Hevezi explained. "We're just at the beginnings of doing this fusion, and it remains to be seen how it's going to be used clinically for benefit to the patient." But, he added, "I think that eventually it's going to benefit patients very much."
Hevezi cited the example of the first case that he worked on using the new imaging combination, saying the patient was initially going to be treated with the IMRT system. "But when we overlaid PET onto it, it turned out that there was more disease in the area indicated by PET, so we're probably going to treat that patient with conventional therapy, rather than with the more sophisticated, more expensive IMRT system."
This new combination system provides more information than the two imaging modalities normally would alone, said Hevezi. "The CT data set just shows abnormal densities, and those are kind of solid tumors." These are normally treated with radiation.
PET, however, is able to look at the function of the rapidly dividing cells in these tumors, which may not be evident on the CT data set. "So the overlay gives both the information about these densities on CT and also the function – how rapidly these cells are turning over and where they're rapidly turning over." And these important areas need to be covered with radiotherapy beams, Hevezi said.
In December, the CTRC installed what is probably the highest-resolution dedicated PET scanner available on the market today, the ECAT HR plus scanner, made by CPS. "When we saw some of the first images out of that thing," he noted, "we said, 'This is phenomenal.'"
CRTC found that the images produced by the CPS device have been useful to all the specialties associated with treating cancer. Initially, medical oncologists used it to follow a course of drug therapy for their patients. Because they now had such good CT-based images for planning radiotherapy beams, Hevezi reasoned "that if we could fuse the PET images slice by slice in correct anatomical registration, then we would get a tremendous amount of information which would then guide us in placing our radiation beams on patients even more precisely." He said that this, in fact, has been the case and that the combination therapy has allowed increasing dose accuracy.
Hevezi envisions using this enhanced technology to treat, among other things, lung and brain cancer. "The course of those diseases you don't see until the patient presents with symptoms, and by then it's too late to do much about it." Both of these cancers thus have historically had low survival rates, he noted, data he hopes to improve with a screening tool using the high-resolution CT scans. If patients present with suspicious images, they would then be sent in for PET scans. In this manner, Hevezi hopes, patients' cancer can be detected earlier and a lower level of treatment used.
Hevezi hopes to have initial data on the new treatment regimen published in professional journals in the near future, with detailed follow-up reported later.
CPS is a joint venture between Siemens Medical Systems (Erlangen, Germany) and CTI (also Knoxville), the latter a supplier of PET products and services.
Elsewhere in the product pipeline:
Armstrong Healthcare (High Wycombe, United Kingdom) unveiled a new robotic system, named PathFinder, with the company billing it as an intelligent technology for guiding delicate surgeries and other procedures in the brain. The PathFinder system uses a camera that automatically matches a scanned image with the surgical target in the brain and then directs the surgical instruments to that target. A key advantage, according to the robot's developers, is the reduction of damage to surrounding healthy tissues. The company rolled out its plans for the device during a news conference in London, with Patrick Finlay, managing director of Armstrong, called the positioning device "safe and simple to use in increasingly complex procedures." Possible applications could include removal of brain tumors and also new treatments for epilepsy, Parkinson's disease and potential new applications of stem cell replacement strategies, according to the company. It said that clinical trials using PathFinder will soon be launched at Queens Medical Centre (Nottingham, United Kingdom).
Biolase Technology (San Clemente, California) said it has received notice of approval to sell its Waterlase hard and soft tissue lasers in South Korea. The company's Korean distributor, Daemyung Medi-Tech, is a large player in the Korean dental market and will be working with more than 20 sub-distributors to sell the Waterlase, Biolase said. It said sales are projected to exceed $1 million in 2002. Biolase makes dental, cosmetic, aesthetic and surgical products, including Waterlase surgical cutting systems and other laser and non-laser products for the medical market.
BioSyntech (Laval, Quebec) said it would be initiating human clinical trials in Europe on BST-InPod, a new product for treating foot fat pad atrophy, in October. According to the company, this new product allows restoring the comfort of feet damaged by age, high impact sports, illness, steroid injection, or by the repeated use of thin-sole or high-heel shoes. With the normal loss of fat pads with age, pressure area starts developing over the metatarsal and the heel area as early as age 30. Over the years, this gradually aggravates into some form of walking discomfort and pain. BST-InPod can restore the cushioning of these pads, according to the company. The product is analogous to an injectable foot cushion, with its components having GRAS (Generally Regarded As Safe) designation from the FDA, which is expected to accelerate the regulatory approval process. In Europe, the product is classified as a Class III medical device and the fact that the components are non-toxic, greatly facilitates CE marking, BioSyntech said, adding that it is targeting launch of the product in Europe early next year. An investigational device exemption application will be submitted to the FDA this fall, and BioSyntech is hoping to initiate U.S. clinical trials early next year. BioSyntech specializes in tissue repair and biotherapeutic delivery products.
Boston Scientific (Natick, Massachusetts) reported that its FilterWire EX embolic protection device received the CE mark for a carotid application. The device received the CE mark for coronary and saphenous vein graft (SVG) applications earlier this year and for use in the peripheral circulatory system last October. The FilterWire EX device is designed to capture embolic material dislodged during angioplasty and vascular interventions that could otherwise travel through the bloodstream to the heart or brain causing heart attack or stroke. The device is manufactured by Embolic Protection (Campbell, California), acquired by Boston Scientific in February. The FilterWire EX is the latest addition to the Boston Scientific carotid systems franchise, a platform of rapid exchange devices, including the Carotid Wallstent Monorail endoprothesis. It is currently in a clinical trial in the U.S. for use in protecting saphenous vein graft procedures, and will soon be in a U.S. trial to support approval for the carotid indication.
Caliper Technologies (Mountain View, California) released the Caliper 250 HTS system, the company's new LabChip-based high-throughput screening (HTS) system. The 250 HTS system, which includes instruments for assay development and screening, a menu of chips that perform standard assays, as well as Caliper-supplied support services and custom solutions, is designed to provide a new, microfluidic chip-based approach to high-throughput drug screening. LabChip systems miniaturize, integrate and automate high-volume screening to enable researchers to perform complex, multi-step experiments in a fraction of the time with far less user intervention, using tiny quantities of precious reagents. Caliper said it would begin shipping the new systems in November. The system performs screening experiments in a serial, continuous flow fashion inside the microchannels of the chip, constituting a closed, controlled environment. The chip uses a proprietary capillary-like sample access system, called a sipper, through which nanoliters of test compounds are drawn into the channels of the chip from microwell plates, where they are mixed with equally tiny quantities of the target biomolecule and other reagents for screening. The 250 HTS system uses a four-sipper chip capable of performing tens of thousands of experiments per chip, per day, depending upon assay conditions, and offers "walk-away" automation and minimal user intervention, the company said. Caliper's LabChip devices and systems enable experiments that ordinarily require laboratories full of equipment and people to be conducted on a chip small enough to fit in the palm of a child's hand.
Hemosol (Toronto, Ontario) said it has submitted proposed amendments to its Hemolink U.S. clinical development and registration plans to the FDA, to address issues raised by the agency in August regarding the design of the pivotal U.S. Phase III trial. Once agreement is reached, specifics regarding the clinical program and revised timelines for the company's U.S. clinical and regulatory program for Hemolink will be announced. The company reported that other major initiatives are proceeding as planned. Hemosol's response to the questions posed by Health Canada regarding its application to market Hemolink in Canada has been found acceptable for review. Health Canada has a 90-day target to complete the review and, based on this timeline, Hemosol expects a final response before the end of 2001. Regarding its application to market Hemolink in the UK, Hemosol has scheduled a meeting later this fall to discuss the questions recently posed by the Medicines Control Agency. Hemosol said it intends to follow the Mutual Recognition Procedure registration route, using the UK as the reference member state, to bring Hemolink into the European market. Hemolink is a hemoglobin-based oxygen carrier derived from human red blood cells.
HydroCision (Andover, Massachusetts) said it has received CE mark approval for its fluidjet-based surgical systems, which include the ArthroJet, TraumaJet and UlcerJet. HydroCision also said that it has received ISO 9001 certification for its design, development, manufacturing and service operations. The company already has 510(k) clearances from the FDA to market these systems. Surgical Modality Ultrahigh-pressure fluidjets have the ability to cut, sculpt, or drill tissue with a high degree of precision and leave a smooth surface. By controlling the device design, fluidjet technology enables differential ablation; i.e., the ability to selectively remove tissue of various densities – ranging from fat and muscle tissue to cartilage and bone. Based on HydroCision's proprietary technology, the fluidjet device will simultaneously remove all tissue fragments. Potential thermal damage to surrounding tissue is avoided, since fluidjets do not generate heat, according to the company.
IGEN International (Gaithersburg, Maryland) said it would present research results from four new screening tests to speed the discovery of new drugs at the annual meeting of the Society for Biomolecular Screening in Baltimore, Maryland. The studies will highlight the company's new assays for HIV-1 integrase, ubiquitination, phosphorylation and transcription factors. The assays are designed to screen for and identify new drug candidates for AIDS, cancer, and a wide range of other diseases.
InforMax (Bethesda, Maryland), a provider of bioinformatics software solutions, has released Xpression NTI, a desktop application for the analysis of gene expression data. The company said that Xpression NTI provides a variety of algorithms for the processing and analysis of data from single and multiple microarray expression experiments, including filtering, sorting, clustering, parameterization or profiling, as methods used to analyze and organize data. With Xpresssion NTI, quantitative data is displayed graphically to expose inherent patterns and an understanding of the underlying regulation of gene expression. Microarrays are best known for measuring differential expression – the comparison of relative levels of gene expression between two populations of cells. This technique allows the identification of a gene whose expression is turned on or off in a particular disease state and the simultaneous identification of the expression levels of thousands of genes in diseased and normal tissue. InforMax products support high-throughput research, minimizing the time and cost of discovering and validating valuable targets for pharmaceutical, therapeutic and diagnostic development.
Medtronic (Minneapolis, Minnesota) said that Crawford Long Hospital (Atlanta, Georgia) became the first medical facility in the nation to perform an implant of InSync, a new heart failure device approved by the FDA in late August. Dr. Angel Leon performed the procedure Sept. 6 on a 62-year-old Cartersville, Georgia, woman, implanting the InSync cardiac resynchronization therapy system in approximately one hour at the Carlyle Fraser Heart Center. Medtronic said the InSync is the first major therapeutic breakthrough for heart failure patients since the development of specialized heart failure drugs. The treatment is designed for patients who have moderate-to-severe heart failure. Leon was a primary investigator during the clinical trial that evaluated the safety and effectiveness of the new therapy. Leon and his associate, Dr. David DeLurgio, have enrolled more than 200 patients in cardiac resynchronization therapy studies. The InSync system includes a small pulse generator (about the size of two stacked silver dollars) that is implanted beneath the skin in the shoulder region. Through leads, the system delivers synchronized electrical stimulation to three chambers of the heart, enabling them, said the company, to pump blood more efficiently throughout the body.
Molecular Devices (Sunnyvale, California) released its CatchPoint Cyclic AMP Assay Kit, the first in a series of assays that the company expects to provide high sensitivity, prepackaged in a 384-well plate format compatible with high-throughput screening. According to the company, the CatchPoint assay is non-radioactive and 10 times more sensitive than alternative commercial assays. The novel formulation generates a fluorescent readout that resists interference from drug compounds, and the protocol does not require exact temperatures or exact incubation times, making it well-suited for batch processing or robotic handling. Molecular Devices is a supplier of high-performance bioanalytical measurement systems.
Novartis Ophthalmics (Duluth, Georgia), the eye health unit of Novartis AG (Basel, Switzerland), and QLT (Vancouver, British Columbia) said they filed Visudyne (verteporfin for injection) therapy with the Canadian Therapeutics Products Directorate (TPD) for the treatment of a select group of patients with occult subfovealchoroidal neovascularization (CNV) caused by wet age-related macular degeneration (AMD). AMD is the leading cause of blindness in people over the age of 50. This submission is based on favorable two-year results from a Phase III clinical trial showing Visudyne has a significant treatment benefit in AMD patients with occult CNV. The submission specifically seeks approval for patients with occult AMD with smaller lesions or lower visual acuity. Visudyne is commercially available in 50 countries for the treatment of predominantly classic subfoveal CNV caused by AMD. It is is approved in more than 20 countries, including the U.S., Canada and European Union member states, for the treatment of subfoveal CNV due to pathologic myopia. As part of the Canadian submission, Novartis Ophthalmics and QLT also filed for approval of Visudyne for presumed ocular histoplasmosis, a condition characterized by CNV resulting from a fungal infection of the retina. Visudyne therapy is a two-step procedure that can be performed in a physician's office. First, the drug is injected intravenously into the patient's arm. A non-thermal laser light is then shone into the patient's eye to activate the drug. Visudyne therapy uses a specially designed laser that produces the low level, non-thermal 689 nm light required to activate the drug.
New data presented at last month's European Association for the Study of Diabetes (EASD) meeting in Glasgow, Scotland, demonstrated that the AERx iDMS electronic pulmonary insulin system, currently in clinical development, did not adversely impact respiratory function in patients with asthma. The AERx iDMS electronic system is designed to address all the important criteria for a pulmonary delivery system and is being developed by Novo Nordisk (Bagsvaerd, Denmark) in partnership with Aradigm (Hayward, California). The results suggest that AERx iDMS could be an option for the treatment of diabetes in people who also have asthma. The data was based on a recent study involving non-diabetic subjects. The AERx iDMS previously was shown in single-dose studies to be well tolerated and to lower blood glucose in healthy individuals and people with diabetes. The study was conducted in 45 non-diabetic participants, 28 non-asthmatics and 17 chronic asthmatics, to investigate the safety and tolerability of inhaled insulin via the AERx iDMS system in both healthy and asthmatic subjects, all non-smokers between the ages of 18 and 45. For the asthmatic patients, the results determined that use of the AERx iDMS did not provoke asthmatic attacks or worsen the baseline airway hyper reactivity state of the asthmatic subjects, even with higher doses. Both groups showed the same tolerance for the AERx iDMS. The system uses an electronic breath control feature that guides patients to the correct breathing technique, which ensures deep lung delivery of the insulin dose. The system also features the ability to adjust the insulin dose in single AERx unit increments and a unique data downloading system that will allow patients to review dosing data and may potentially lead to good patient compliance. Novo Nordisk is focused on diabetes care, as well as coagulation disorders, growth disorders and hormone replacement therapy. Aradigm develops aerosol-based drug delivery alternatives to injectable therapeutics.
PerkinElmer (Boston, Massachusetts) has released EnVision, a modular, microplate reader designed for use in high-throughput screening and research laboratories for application areas including reporter gene assays, enzyme assays, receptor ligand binding assays, cellular assays, genotyping assays and future assay types. Because EnVision is modular and flexible, it allows users to select only the application modules they require and supports all non-radiometric detection technologies such as fluorescence intensity, fluorescence polarization, time-resolved fluorescence, luminescence and absorbance, the company said. EnVision connects to existing laboratory hardware and can be integrated with a robotic system or loaded from its own stackers. It accepts all standard microplate formats and will measure a 1536-well plate in less than one minute, the company said. The user loads the assay microplate, selects the appropriate protocol and starts the measurement. PerkinElmer Life Sciences is a provider of drug discovery, research, and clinical screening products, services and technologies for the life sciences.
PharmaSonics (Sunnyvale, California) has initiated SPLASH, a new Phase II trial to study the company's Intravascular Sonotherapy System for the reduction of the rate of restenosis inpatients with failed coronary stenting, called in-stent restenosis. Sonotherapy uses a selective spectrum of therapeutic ultrasound, delivered through a standard catheter after stent implantation or revascularization. "If the clinical trial establishes the effectiveness of sonotherapy in the treatment of in-stent restenosis, I believe it will be the first-line therapy most physicians will be choosing for the treatment of this problem," said Jeffrey Moses, MD, director of interventional cardiology at Lenox Hill Heart and Vascular Institute (New York), and principal investigator for SPLASH. "We believe SPLASH will establish sonotherapy as the therapy of choice for in-stent restenosis, due to its simplicity, ease of use and the fact that extra catheter lab staff are not required," said Menahem Nassi, PhD, PharmaSonics president and CEO. The trial is designed to evaluate the long-term safety and clinical efficacy of sonotherapy in patients being treated for in-stent restenosis in a single native coronary artery. PharmaSonics develops therapeutic ultrasound devices.
Response Biomedical (Vancouver, British Columbia), developer of the RAMP diagnostic system, said that after further discussion with the FDA, it has rescinded the voluntary withdrawal of its recent 510(k) submission. Bill Radvak, president and CEO, said, "We remain confident in the RAMP System and its ability to achieve regulatory clearance. Furthermore, we will continue to move forward with our business development and finance initiatives, and work to restore shareholder value which was negatively impacted by the temporary withdrawal of the 510(k)." Response develops quantitative diagnostic tests for use with its proprietary RAMP Reader intended to be used for clinical, STAT-lab and point-of-care applications.
SonoSite (Bothell, Washington) revealed the results of four new studies with the SonoHeart personal hand-carried ultrasound device at the European Society of Cardiology congress. In two of the studies, investigators concluded that the SonoHeart device is an efficient and low-cost screening tool for abdominal aortic aneurysms and left ventricular hypertrophy (hypertension). Two other studies showed that the SonoHeart device is reliable and potentially useful in the physical exam and in bedside patient management. SonoSite is developing devices for the point-of-service, hand-carried ultrasound market.
St. Jude Medical (St. Paul, Minnesota) has received FDA and CE mark approval for its newest vascular closure product, the Angio-Seal STS Platform. The device is available in 6 Fr and 8 Fr configurations and is indicated for use in closing the femoral arterial puncture sites following diagnostic or interventional catheterization procedures. The STS Platform incorporates a self-tightening suture, which eliminates the need for a post-placement spring, allowing for completion of the entire procedure in the cath lab, the company said. It also integrates a Secure-Cap, which facilitates proper deployment through both tactile and audible confirmation during the deployment process. The STS Platform also uses additional visual markers to provide positive confirmation of a proper anchor-arteriotomy-collagen sandwich. The company values the market for vascular closure devices at more than $300 million dollars and growing at more than 30% annually. St. Jude Medical said it expects to have units available for a limited launch in 4Q01, with full global release in January 2002.
SuturTek (North Chelmsford, Massachusetts) said it is developing a needle-protected suturing technology that is designed to eliminate the risk of suture needlesticks for surgeons, operating room (OR) nurses and staff. The company obtained FDA 510(k) clearance and is designing and testing the first of a series of needle-protected suturing devices based on its patented Safe-Suturing wound closure technology. SuturTek said its devices will directly address the escalating safety concerns and costs associated with suture needlesticks in hospital operating rooms. Suture needlesticks place surgeons, nurses and OR staff at risk for bloodborne infection with HIV, AIDS, hepatitis and other diseases. The company said its technology is the only suturing system that complies with federal and state mandates requiring the use of engineered sharps injury protection for use in open surgery.
Symphonix Devices (San Jose, California) reported releasing a study on the long-term effects of its Vibrant Soundbridge during the American Academy of Otolaryngologists annual meeting, confirming that the device is safe and effective for long-term use. The Vibrant Soundbridge is the first implantable middle ear hearing device (IMEHD) approved by the FDA and is designed to treat the most common form of hearing impairment, moderate to severe sensorineural hearing loss, according to the company. The performance of the Soundbridge was evaluated in the first 100 patients, each of whom chose the device after having prior experience with traditional hearing aids. All subjects were implanted with the device for at least one year, with some representing continuous usage for up to three years. Patients implanted with the Vibrant Soundbridge for 12 months or more continued to report improved hearing performance with minimal background noise interference, better overall fit and comfort and excellent overall sound quality.
Techlab (Blacksburg, Virginia) received FDA clearance for its IBD-Chek, a test for elevated levels of fecal lactoferrin, which is an indicator of intestinal inflammation. The noninvasive diagnostic test now is available to aid in the diagnosis of inflammatory bowel disease (IBD) vs. irritable bowel syndrome (IBS), one of the least understood gastrointestinal diseases and second only to the common cold as a major cause of physician office visits in the U.S., the company said. The test results can be used to help identify patients with active IBD and rule out those with IBS, which is non-inflammatory. IBD, a condition of chronic inflammation, consists of ulcerative colitis and Crohn's disease. Both these diseases result in elevated fecal lactoferrin. As a result, patients with these diseases test positive in the IBD-Chek. In patients with active IBS, the intestine appears normal upon endoscopic examination and there is no indication of inflammation, thus IBS patients will test negative in the IBD-Chek. Techlab is focused on diseases of the intestinal tract, with an emphasis on rapid intestinal diagnostics.
Two studies released last month by Vasomedical (Westbury, New York) support the value of the company's enhanced external counterpulsation (EECP) therapy system. The first of the studies, done at the Graduate School of Medicine at Kyoto University (Kyoto, Japan), offered evidence of how the therapy works at the cellular level. In the other, Georgiann Linnemeier, MD, medical director of the HeartGen Centers (Indianapolis, Indiana), followed 3,037 patients in the international EECP Patient Registry maintained by the University of Pittsburgh (Pittsburgh, Pennsylvania) Graduate School of Public Health Department of Epidemiology. Results showed that 76% of patients over 80 and 82% of patients younger than 80 reported a reduction in angina symptoms by one or more classes immediately following a full course of EECP therapy.
Ventana Medical Systems (Tucson, Arizona), a supplier of automated instrument reagent systems to histology and drug discovery labs, said that the clinical utility of its Inform Human Papillomavirus (HPV) ASR High Risk and Low Risk Probes has been supported by two additional studies that correlated Pap smear results with histology, clinical follow-up and HPV detection. Both studies were presented at the 19th International Papillomavirus Conference in Florianopolis, Brazil. One study was presented by Dr. David Baunoch, vice president of operations at US Labs, a national anatomic pathology laboratory, the other by Dr. Elizabeth Euscher, from a data abstract co-authored by a group of researchers at Ohio State University Medical Center (Columbus, Ohio). The Inform HPV ASR probes are the first automated in situ hybridization, or slide-based, applications for HPV DNA detection and allow physicians to see the cells in their cellular context on a slide. The company said visualization of the cells and the surrounding tissues gives physicians important clues to help determine which patients are at greater risk of developing cervical cancer. The Inform HPV ASR is a recent addition to the menu available for the fully automated BenchMark system.
World Heart (Ottawa, Ontario) and Edwards Lifesciences (Irvine, California) reported that Japan's Ministry of Health, Education, Labor and Welfare (MHLW) has approved World Heart's Novacor Left Ventricular Assist System (LVAS) for commercial use in Japan. The Novacor LVAS is distributed exclusively in Japan by Edwards, which operates in Japan as a joint venture entity with an affiliate of Baxter International (Deerfield, Illinois). The Novacor LVAS is distributed exclusively by Edwards in all countries outside of the U.S. The companies received notification that the device has been approved for use in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure for which there is no alternative except heart transplantation. The companies worked closely with Japanese officials for more than two years in preparing and submitting documentation and test data for review, and now will submit documents required for the necessary import permit. The Novacor LVAS is the first implantable ventricular assist device to receive MHLW approval in Japan, the company said. The device is an implantable, pulsatile pump that takes over most of the natural heart's pumping function and delivers blood to the body, responding to the demands of the recipient's physiological state. The system includes an externally worn controller and rechargeable battery packs that allow the recipient to be discharged from the hospital and resume most normal activities.