Top 10 Innovations for 2009
Welcome to the third edition of our Top 10 Medical Innovations.
We are pleased to share with you the final results of a rigorous selection process that started many months ago when we asked scores of our clinicians and researchers at the Cleveland Clinic the simple question: "Whatgame-changing medical technology, device, or therapy do you see breaking through in 2009?"
Cleveland Clinic's culture of innovation naturally fosters a good deal of discussion about "hot" new technologies and which ones will have the greatest impact each year. The purpose of our annual "Top 10 Medical Innovations" is to share the perspective of our leaders on what innovations they felt would help to re-shape healthcare in the next year. As you turn the pages and move from innovation #10, through to the #1 selection for 2009, we are certain that you will be amazed by the diversity of these innovations, their unique utility, and by their truly game changing nature.
We are pleased to share with you the final results of a rigorous selection process that started many months ago when we asked scores of our clinicians and researchers at the Cleveland Clinic the simple question: "Whatgame-changing medical technology, device, or therapy do you see breaking through in 2009?"
Cleveland Clinic's culture of innovation naturally fosters a good deal of discussion about "hot" new technologies and which ones will have the greatest impact each year. The purpose of our annual "Top 10 Medical Innovations" is to share the perspective of our leaders on what innovations they felt would help to re-shape healthcare in the next year. As you turn the pages and move from innovation #10, through to the #1 selection for 2009, we are certain that you will be amazed by the diversity of these innovations, their unique utility, and by their truly game changing nature.
Cleveland Clinic Top 10 for 2009
#1
Use of Circulating Tumor Cell Technology
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Use of new technology to measure circulating tumor cells as a predictor of success of chemotherapy.
Learn More - Circulating tumor cells (CTCs) are cancer cells that have detached from an existing tumor cell and have entered the bloodstream. Measuring CTCs in a sample of blood can facilitate early detection of recurrent cancer in patients who are known to have the disease. This technological advance helps in understanding response to therapy much sooner, allowing patients to monitor their progress at any point along their treatment course, and guiding the doctor in adjusting therapy as needed.
The FDA has approved the use of CTC detection to monitor treatment effects in breast, colorectal, and prostate cancers, while other applications are under active development. In June 2011, the first prototype to commercialize more accurate circulating tumor cell detection technology was completed.
#2
Warm Organ Perfusion Device
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Warm organ perfusion device to preserve organs for transplantation during transplant.
Learn More - By slowly pumping warm blood through organs and keeping them in a functioning state, this game-changing innovation offers a much better way to transport a variety of living organs-such as hearts-for transplantation. By extending the time that a donor organ can be maintained outside of the body, this technology not only provides better preservation of an organ's function prior to transplant, but should also help to ameliorate the effects of the worldwide donor organ shortage, which remains one of the biggest problems in this field.
The world's first warm blood perfusion system for the heart has been approved for use in Europe and it is currently undergoing pivotal multicenter testing in the U.S. A national clinical study comparing the effectiveness and safety of the warm organ perfusion device with the traditional icebox method for keeping donor hearts healthy is under way. As of July 2010, there have been 100 such heart transplants in both Europe and the U.S.
#3
Diaphragm Pacing System
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Use of a diaphragm (phrenic nerve) stimulator to enable paralyzed patients to breath without the assistance of a mechanical ventilator.
Learn More - This novel device enables paralyzed patients to breathe without the assistance of bulky mechanical ventilators. It electronically stimulates the diaphragm, causing it to contract, allowing air to move into and out of the lungs to provide unassisted and more natural breathing.
Diaphragm-pacing systems have been approved by the FDA and are commercially available in the U.S., and can be implanted using minimally-invasive surgical techniques. These devices can dramatically reduce the rates of ventilator-induced pneumonia in paralyzed patients and help to improve patients' overall quality of life. In January 2011, the first instance of a diaphragm pacing system replacing a mechanical ventilator in ventilator-dependent children was reported. In addition, a diaphragm pacing system received Humanitarian Use Device designation from the FDA, allowing it to be used by people with amyotrophic lateral sclerosis.
#4
Multi-Spectral Imaging Systems
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Improvements in multi-spectral image analysis to assess multiple protein pathway configuration in a single sample/cell.
Learn More - Once attached to a standard microscope, this imaging system enables researchers to spectrally resolve up to five or six chromogens (colors) that are used to stain specific elements in a single tissue section and accumulate more information compared to previously existing techniques. The ability to stain for multiple cell markers substantially speeds information acquisition by providing results from a single assay that would normally require multiple tests. In addition, simultaneous staining of multiple markers allows researchers to better understand interrelationships of complicated signaling pathways in cancer cells (or other abnormal tissues), allowing the development of more effective therapies.
Several multi-spectral imaging systems have been developed within the past few years that have current clinical applications and will continue to provide important diagnostic advances in the future. A new class of medical endoscopes enhanced by multispectral imaging technology is currently under development to help surgeons collect information about human tissue signatures with speed and resolution surpassing anything currently available on the market. In late 2010, a new and more accurate type of microscope that enabled simple image capture was released.
#5
Percutaneous Mitral Valve Regurgitation Repair
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Use of a special clip to percutaneously repair mitral valve regurgitation (MVR).
Learn More - This innovative procedure has been demonstrated to work well for some people with moderate to severe mitral regurgitation or leakage of the inlet valve for the left ventricle. This backward leakage of blood through the mitral valve can cause congestion in the lungs, increased work for the heart, and heart failure. During the procedure, which is performed in the cardiac catheterization laboratory, a wishbone-shaped clip is threaded through a catheter in blood vessels in the groin to the leaking mitral valve. The clip is then applied to bring the center of the two mitral valve leaflets together, which eliminates the backward leakage of blood through the valve and restores normal blood flow into the left ventricle.
While open heart surgical techniques remain the clinical standard of care, the mitral valve clip will likely be an important additional treatment for this disease, particularly in patients for whom surgery is too high a risk. Already approved for use in the EU, the mitral valve clip system had been placed in 3,000 patients worldwide before it was voluntarily recalled in May 2011 due to problems with the delivery system. Detailed investigations and minor modifications are being conducted. The mitral valve clip is not yet approved in the U.S., but it is being used on a limited basis in the ongoing EVEREST II clinical trial.
#6
New Strategies for Creating Vaccines for Avian Flu
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Use of new strategies for creating vaccines for avian flu, including genetically-engineered virus-like particles (VLPs) as the basis for vaccines.
Learn More - With the potential to alter management of a potential worldwide health crisis, the novel vaccine strategy uses a mock version of the bird flu virus called a virus-like particle (VLP). This offers a better solution to protect people against infection from the deadly avian virus. VLP-based vaccines do not require live virus for their development, which results in vaccines that are easier and faster to produce. Significantly shorter development and production times compared to live virus vaccines, allow public health authorities to react more quickly in the event of a potential pandemic. With this technology, an influenza vaccine can be created in just 10 to 12 weeks from the identification of a new viral strain.
Several VLP vaccines targeting H1N1 and H5N1 viruses have been created and are currently being tested in multiple human clinical trials. Positive interim results from phase 2 clinical trials for H5N1 vaccine trials were reported, while a clinical trial with a pandemic VLP vaccine has been started.
#7
LESS and NOTES Applications
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Laparoendoscopic single-site surgery (LESS) and Natural Orifice Transluminal Endoscopy (NOTES) for nephrectomy, cystectomy, prostatectomy, colon resection, and other applications.
Learn More - Laparoendoscopic single-site surgery (LESS) and Natural Orifice Transluminal Endoscopy Surgery (NOTES) allow doctors to perform surgeries with a minimum of cutting and virtually no scars. Pain levels and recovery times are significantly reduced with these scarless surgeries, allowing patients to return home and resume daily activities much more quickly.
LESS and NOTES have been successfully utilized and continue to evolve in multiple clinical areas. Urologic, gynecologic, and digestive-tract procedures have already been successfully completed. NOTES is still an investigational approach in urology while LESS is immediately applicable in the clinical field. LESS and NOTES robotic instruments have recently been introduced and are currently under evaluation for their roles in minimally invasive urologic surgery.
#8
Integration of Diffusion Tensor Imaging (Tractography)
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Integration of diffusion tensor imaging (tractography) with surgical navigation of the brain to minimize damage to fiber tracts during brain surgery.
Learn More - This technology is providing important information for neuroscientists probing the long neglected portion of the brain known as white matter, with its densely packed collection of intertwining fibers that allows neurons in the lobes of the brain to communicate with each other. Prior to the development of this technique, assessment of these critical areas was impossible in the living brain. This approach, which employs a modified version of magnetic resonance imaging, is being evaluated in a number of clinical applications. One particularly important area may be its use in preoperative planning prior to invasive neurologic procedures. Doctors can precisely map out a detailed spatial wiring map of the brain and avoid damage to these sensitive areas during neurosurgical procedures. Several studies published in early 2010 demonstrated the superiority of this technology in detecting various forms of dementias and cognitive impairments. Since this is the only non-invasive technique that allows in vivo dissection of white matter tracts, it is increasingly used in pre-surgical mapping in tumors located in the areas of the brain that allow us to communicate, perceive, interact, and have movement.
#9
Doppler-Guided Uterine Artery Occlusion
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Doppler-guided non-invasive transvaginal uterine artery occlusion for treatment of symptomatic uterine fibroids.
Learn More - This is an innovative method to treat uterine fibroids, which are benign muscular tumors of the uterus that are a common cause of pelvic pain and heavy menstrual bleeding. It offers women who have failed medical therapy a minimally invasive alternative to hysterectomy. Through temporary occlusion of uterine arteries, this technology can significantly reduce fibroid size and related symptoms.
The experimental procedure is currently undergoing pivotal clinical trials at centers throughout North America and Europe. A pilot study to determine optimal procedure steps to obtain and maintain uterine artery occlusion with the Doppler-guided device was initiated in 2010, but was terminated in 2011 because further internal evaluation of the device was needed.
#10
Private Sector National Health Information Exchange
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Use of a common exchange standard among participants to enable access through the Internet regardless of provider source.
Learn More - This is a comprehensive system of electronic health records that connects, stores, and shares clinical data from hospitals, physician offices, pharmacies, labs, and other sources to help improve communication flow between healthcare providers, patients, and clinicians. It has the potential to revolutionize our healthcare management by reducing the risk of medical errors, lowering costs, and increasing the overall quality of healthcare.
Although primarily a private sector effort, this computerized system is gaining increased public interest. With the enactment of the American Recovery and Reinvestment Act (ARRA), which places a very strong emphasis on the importance of health information exchange, significant ARRA funds have been spent in support of health information exchange efforts. The recent issuance of two regulations defining and supporting "meaningful use" of electronic health records has laid solid foundation for the ubiquitous and effective use of health information technology in the near future. Formal organizations are emerging to provide both form and function to independent and governmental/regional level health information exchange efforts. Federal and state regulations regarding Health Information Exchange are still being defined and investigated.
