This page provides updates on the Top 10 selections that have been presented through the years. Updates are now available.
1. Bone Conduction of Sound for Single-Sided Deafness
Single sided deafness (SSD) affects 9 million people in the U.S. The newly developed non-surgical, non-invasive, removable hearing device bypasses this requirement by transmitting sound via the teeth and bones, to both cochleae. This digital audio device is nearly invisible and consists of a small microphone unit worn behind the ear on the deaf side and an easy-to-remove dental retainer-like processor for the conversion of audio signals into vibratory energy.
The world’s first non-surgical, non-invasive bone-conduction hearing device has recently completed a pivotal clinical trial, and the study results have been submitted to the FDA. In addition to SSD, the intended future indications also include addressing the needs of patients with conductive, mixed hearing loss, and tinnitus.
2. Low-Volume, Low-Pressure Tracheal Tube Cuff to Reduce Ventilator-Associated Pneumonia
Ventilator-associated pneumonia (VAP) is the leading cause of hospital-acquired mortality in the ICU and is estimated to result in $1.5 billion in excess expenditure each year. The newly developed endotracheal tube cuff has a special suction setup that provides continuous effective airway seals at low mucosal pressures. It allows all secretions to drain from the subglottic space just above the tube cuff, which dramatically reduces the risk of VAP and death in the hospital ICU.
This device received the 510(k) clearance from FDA in late 2009. More physicians are now able to take advantage of this innovative technology to reduce the incidence of VAP and further improve patients’ safety.
3. Continuous-Flow Ventricular Assist Devices
The newest version of continuous-flow ventricular assist devices weighs only 3 ounces. It is attached alongside the native heart and runs on rechargeable batteries connected through the abdomen. The new device can quietly and effectively take over the pumping ability of the heart by generating up to 10 liters of blood flow per minute and providing up to 10 years of circulatory support.
This device has earned a CE Mark for both bridge-to-transplant and lifetime use and is currently used in the United States as a bridge-to-heart transplant under FDA-approved clinical investigation.
4. Non-Vitamin K Antagonist Oral Anticoagulants
Venous thromboembolism (VTE), which is caused by abnormal blood clot, is a serious life threatening condition that affects more than 1 million Americans annually. Two newly developed non-vitamin K antagonist oral anticoagulants, which target the Factor Xa and thrombin respectively, now offer predictable and well-tolerated alternatives to the oral anticoagulant warfarin and can provide a more convenient-and safe-way for patients to dose themselves and prevent blood-clot formation.
Approved for use in Canada and Europe, both drugs have already completed the long-term phase III clinical trials and study results are currently under review by the FDA. Dabigatran received FDA approval in October 2010.
5. Fertility Preservation Through Oocyte Cryopreservation
Thanks to the new cryopreservation techniques developed in Italy and elsewhere, this novel reproductive technology is now allowing eggs of a healthy woman to be safely frozen and stored, ready to be thawed and fertilized at a later date.
Currently, oocyte cryopreservation is offered in more than 50% of Assisted Reproductive Technology clinics in the United States. There have been more than 1,000 healthy births as a result of this novel egg-banking technology.
6. Forced Exercise to Improve Motor Function in Patient’s With Parkinson’s
Parkinson’s disease (PD) is a debilitating brain disorder that affects more than 1 million Americans and has no cure. While current available medicines help ease the PD symptoms for a few hours, a novel exercise-based therapeutic strategy can now bring relief to patients for weeks. By conducting “forced exercise” (tandem riding in which patients are forced to pedal 80-90 RPM), patients’ motor function was dramatically improved by 35% and this improvement lasted for 4 weeks after the training ended.
Used either alone or as an adjunct to other therapies, forced exercise has opened up a promising avenue in PD treatment and management. Further studies are now ongoing.
7. Outpatient Diagnosis of Sleep-Related Breathing Disorders
Sleep-related breathing disorders have historically been assessed by means of an all-night sleep study in a hospital-based sleep disorder lab. With the increase of public awareness of sleep-related disorders, there are not enough sleep centers to meet the burgeoning demand for diagnosis. That is now changing with the introduction of the patient-friendly self-contained sleep-monitoring devices that allow for the sleep testing to be performed anytime in a patient’s home. Data collected through testing can be accessed by clinical professionals for further analysis.
Recent studies have shown that home portable monitor testing is as effective as traditional sleep lab testing in the screening and diagnosis of sleep-related breathing disorders. With improved patient access to care and reduced costs, home testing may soon replace expensive sleep-lab testing.
8. Oral Thrombopoeitin (TPO) Receptor Agonist that Stimulates Platelet Production
An estimated 50,000 to 100,000 people in the United States are diagnosed with chronic immune thrombocytopenic purpura (ITP). Patients with ITP have low blood platelet count that may produce bruising or excessive bleeding. While most cases of ITP can be controlled, the response to medication is often disappointing and associated with risk. A recently approved oral thrombopoietin receptor agonist has shown high effectiveness in the treatment of ITP by stimulating production of cells in bone marrow that form platelet cells in the blood. Patients taking this new drug were 10 times more likely to reach the target platelet counts as the control group.
Further studies are undergoing to evaluate the safety and efficacy of the drug not only as a long-term treatment for ITP, but as a possible treatment for patients with hepatitis-C-related thrombocytopenia and for patients receiving chemotherapy for leukemia.
9. Devices for Occluding Left Atrial Appendage to Reduce Stroke Risk
Compared to people with normal heart rhythm, patients with atrial fibrillation (AF) have a five-fold increased risk of suffering a clot-related stroke and thus have to take anticoagulant medications, such as warfarin, to manage their AF-related stroke risk. However, warfarin is a problematic medication to use and the drug dosage needs to be monitored regularly. By implanting a left atrial appendage occlusion device, which is specially designed to prevent the formation of blood clots, patients may now discontinue warfarin use.
The FDA has recently approved one clip-based occluding device to be implanted into AF patients during open-heart surgery. Several other devices are currently under clinical trials and are expected to reach market in the coming years.
10. Whole-Slide Imaging for Management of Digital Data in Pathology
Whole-slide imaging is a new technology that converts conventional glass slides into digital pathology slides with excellent image quality that can be viewed, managed, stored and streamed over the Internet, and analyzed on a computer. With this technology, pathologists can now scan a slide within seconds and share it immediately and conveniently with peers anywhere in the world. This technology offers tremendous promise for improving patient care by delivering faster diagnoses, reducing patient morbidity and mortality, and lowering overall medical costs. In addition to supporting primary diagnosis, it also provides valuable information to personalized medicine.
The U.S. Patent and Trademark Office has recently issued a patent to a digital pathology company for the techniques involved in the processing and displaying of digital slide images stored on a server.
1) Use of Circulating Tumor Cell Technology: Circulating tumor cells (CTCs) are cancer cells that have detached from an existing tumor 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, allows patients to monitor their progress at any point along their treatment course, and guides the doctor in adjusting therapy as needed. At present, 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.
2) Warm Organ Perfusion Device: By slowly pumping warm blood through organs and keeping them in a
functioning state, the 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 heart has been approved for use in Europe and it is currently undergoing pivotal multi-center testing in the United States, with systems for transporting lungs, livers, and kidneys also under development.
3) Diaphragm Pacing System: This novel device enables paralyzed patients to breathe without the assistance of bulky mechanical ventilators. It electronically stimulates the diaphragm muscle causing it to contract, allowing air to move into and out of the lung to provide unassisted and more natural breathing. Currently, diaphragm-pacing systems have been FDA approved, 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 life quality.
4) Multi-Spectral Imaging Systems: 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 that will continue to provide important diagnostic advances in the future.
5) Percutaneous Mitral Valve Regurgitation Repair: 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 or pumping chamber of the heart. This
backward leakage of blood through the mitral valve can cause congestion in the lungs, increased work for the heart and ultimately
heart failure. During the procedure, which is performed in the cardiac catheterization laboratory replacing an open heart surgical
procedure in select patients, 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.
Preliminary results in a randomized trial, the EVEREST II (Endovascular Valve Edge-to-edge REpair STudy comparing the valve clip with open heart surgery, suggest that three-quarters of select cases can avoid surgery during the next three years. 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.
6) New Strategies for Creating Vaccines for Avian Flu: With the potential to alter management of a potential worldwide health crisis,
the novel vaccine strategy using a mock version of the bird flu virus called a virus-like particle (VLP) 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. For example, if the World Health
Organization detects a new deadly viral strain emerging in a certain region of the world, rapid development of a VLP vaccine may be
used to quickly immunize unaffected regions and avert a worldwide pandemic.
Avian flu VLP vaccine is currently being tested in multiple human clinical trials. A novel H1N1 vaccine was recently created in less than 12 weeks.
7) LESS and NOTES Applications: Laparoendoscopic single-site surgery (LESS) and Natural Orifice Transluminal Endoscopy
(NOTES) allow doctors to perform surgeries with a minimum of cutting and virtually no scars. These developing techniques represent
the evolution of minimally invasive approaches originally developed in the 1990's that allow performance of extensive surgical
procedures with minimal or no external 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 procedures have been successfully utilized and continue to evolve in multiple clinical areas, including surgery of the digestive tract, urology, and gynecology.
8) Integration of Diffusion Tensor Imaging (Tractography): 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 (MRI), 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. Using this technology, doctors can precisely map out a detailed spatial wiring map of the brain and avoid damage to these sensitive areas of the brain during neurosurgical procedures.
9) Doppler-Guided Uterine Artery Occlusion: 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
The experimental procedure is currently undergoing pivotal clinical trials at centers throughout North America and Europe.
10) Private Sector National Health Information Exchange: 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 health care providers, patients, and
clinicians. It has the potential to revolutionize our health care management by reducing the risk of medical
errors, lowering costs, and increasing the overall quality of health care.
Although primarily a private sector effort, this computerized system is gaining more and more 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 will be spent in support of health information exchange efforts.
1) Flexible Intralumenal Robotics: A novel catheter-based technology has been developed that allows precise
remote manipulations within the intra-luminal space with precision and reproducibility that surpasses human
capabilities. This technology is likely to have applications in urology, cardiology, cardiac surgery, and other
Increasing clinical experience has been acquired for this truly cutting-edge device technology, particularly in interventional cardiology as well as a number of other fields. It has proven especially useful in electrophysiology applications to assist in catheter positioning during ablation procedures; however, this technology holds great promise for wide-ranging catheter-based technologies such as endovascular grafting procedures. Similar systems are currently being developed for applications in a number of fields such as urology. Current device development is focused on improving precision, ergonomics, and reducing occupational radiation exposure.
2) Percutaneous Aortic Heart Valves: For high-risk patients, a technique has been developed that involves inserting a new
expandable wire mesh valve with internal valve leaflets. These valves can be inserted through blood vessels in the groin and
threaded into the heart or through a small chest wall incision.
The indications, benefits and pitfalls of this technology are now being explored in numerous international clinical trials. In addition, major valve makers have made multiple strategic acquisitions of new supporting technologies to position their products for this promising market. Development of technologies for percutaneous valve replacement or reconstruction of the mitral and pulmonary valves has progressed as well.
3) RNA-based Therapeutics: This particular innovation uses RNA antisense technology to treat patients who are unable to reach their targeted cholesterol levels with statins alone or who are statin intolerant. The therapy is intended to reduce the production of ApoB-100, a protein that carries certain forms of cholesterol and triglycerides in the bloodstream. Phase III trials are underway to evaluate the efficacy of RNA antisense-based technology on patients with familial hypercholesterolemia. Other clinical trials are also being conducted to examine efficacy in reducing low-density lipoprotein (LDL) levels in high-risk hypercholesterolemia patients with encouraging early results. Clinical trials are also underway for this technology for a diverse range of conditions including viral infections, cancer, macular degeneration, and hereditary hypercholesterolemia.
4) Convergence of Advances in Genome Scanning and Informatics to Support Clinical Applications: Genetic testing that
can be used for personalized risk assessment and disease management has undergone very rapid development during the past
couple of years particularly in cardiology, with the number of commercially available genomic tests growing by 25% annually.
Clinicians are trying to corroborate the findings yielded by this technology with clinical events.
Most of these tests look at a single gene and are used to diagnosis rare genetic disorders; however, whole genome scanning is also being developed with a number of companies in this increasingly competitive field. There is growing interest in the development of tests that look at multiple genes that may increase or decrease an individuals' global risk for diseases such as cancer or diabetes.
5) Oral anticoagulant Drugs for Treating and Preventing Thrombosis: Newer anticoagulant treatments are being introduced
with the goal of curbing complications such as bleeding and thrombosis.
In the past year, increasing experience has been obtained with new generation oral anticoagulants (such as anti-Factor Xa and direct thrombin inhibitors) in various stages of clinical trials. Compared to existing therapies, these agents continue to hold great promise for providing effective anticoagulation for patients with atrial fibrillation or who are at risk for deep venous thrombosis. Early results of clinical trials with these new agents suggest that they may be used with decreased complications and easier monitoring compared with existing treatments.
6) Live Attenuated Influenza Vaccine for Children as Young as Two Years: Nasal drops containing
live attenuated flu can be used as a vaccine in lieu of needles, and provide effective protection from
influenza for this high-risk population.
Beginning with the 2008/09 influenza season, annual vaccination for all children aged 6 months to 18 years was recommended. Live attenuated influenza vaccines have been approved by the FDA for children two years old and greater and are particularly effective in suitable patients.
7) Image Fusion for Diagnostic and Therapeutic Use: This technology is used to diagnose
medical problems, both anatomic and physiologic in nature, as well as to assist minimally invasive
procedures-such as stent placement or tumor ablation.
Current development is focused on determining which applications of the technology produce the most benefit and refining indications. SPECT/CT imaging in cardiovascular disease holds promise for combined imaging of the myocardium and coronary arteries in ischemic heart disease and as a tool to determine the inflammatory nature of plaque burden. SPECT/CT can be a useful adjunct in oncologic imaging, especially for neuroendocrine tumors or melanoma and may provide more detail regarding the extent of disease in these cases. SPECT/CT can also be a useful adjunct in determining the extent of disease in cases of infected device implants, such as infected joint prostheses.
8) Implanted Device Allowing Neural Control of Objects by the Severely Disabled: Novel
communication interfaces are being developed for severely motor-impaired individuals to provide the
ability to control devices and to potentially restore limb movements. This interface system is designed
for individuals paralyzed by spinal cord injuries, stroke, amyotrophic lateral sclerosis (ALS), and other
advanced central nervous system diseases.
Current technology utilizes multiple electrodes incorporated into a tiny device that is surgically implanted into areas of the brain that control movement. The neuronal signature from these areas then undergoes decoding to direct the movement of a computer cursor and other assistive devices. Pilot clinical trials are currently being conducted and in a limited number of patients have demonstrated that patients can indeed exert control of external devices with their thoughts and can direct communication technology such as email by visualizing the movement of their hand.
9) Engineered Cartilage Products for Joint Repair: Biomaterials have been developed to replace
joint cartilage damaged from injury or arthritis. The materials are surgically implanted into the joint
with the intent to restore the damaged cartilage and avoid joint replacement surgery.
Advancements are being made for technologies that employ autologous and synthetic materials used for cartilage substitutes in joint reconstruction. All replacement technologies must reproduce the delicate interplay between cellular, structural support and biomolecular elements that constitute normal cartilage. New materials currently under development have been shown to be stronger and to possess the ability to better withstand pressure than materials used in previous generations of this technology.
10) Dual Energy Source Computed Tomography (CT) Imaging: The CT device features two X-ray sources and two radiation
detectors, which allow for imaging of patients more quickly and with less radiation. The speed at which the dual-source scanner
operates allows physicians to image patients with high or irregular heart rates, which used to be a significant limitation of this
Increased speed in image acquisition provided by a dual energy source has greatly expanded the application of CT imaging in cardiac disease. Clinicians are now applying this technology to a number of settings where it has proven particularly valuable such as vascular imaging, evaluation of renal disease and CT colonography. Imaging protocols for dual energy source CT studies can now be performed with equivalent or even lower radiation exposure than before.
1) Cancer Vaccines: These targeted therapies are being used to prevent cancer and treat patients more specifically according to
the type of cancer they have. One example of a cancer vaccine is the HPV vaccine developed to prevent cervical cancer caused by
Approximately 25% of American teenage girls were vaccinated with the HPV vaccine in 2007. Currently, researchers are working on developing therapeutic vaccines for a variety of cancers including breast, lung, colon, skin, kidney and prostate. Recently, a new vaccine that employs cells from patients that have been activated against proteins in prostate cancer awaits FDA approval.
2) Designer Therapeutics Using Selective Receptor Antagonists: Novel therapeutics have been created to block receptor activation
that leads to improved patient outcomes. Examples include therapeutics that block the peripheral side effects-such as constipation
and nausea-of opioid medications for pain which can adversely affect patients and lengthen hospitalizations; and control the
body's stress response to mediate eating and smoking.
Research in this area continues with new trials being conducted in multiple areas such as treatment of muscle and bone disorders.
3) Neurostimulation for Psychiatric Disorders: Neurostimulation, such as deep brain stimulation (DBS), is emerging as a
significant treatment option for millions of Americans who are suffering from treatment-resistant depression and treatment-resistant
Studies of DBS in the treatment of resistant forms of depression continue to show promise. DBS has been approved by the FDA for the treatment of Parkinson's, dystonia, essential tremors, and drug-resistant obsessive compulsive disorder. Other current research is focusing on the use of DBS for multiple clinical applications, such as the treatment of Tourette's syndrome, drug-resistant epilepsy, and obesity.
4) Optical Coherence Tomography (OCT): This noninvasive imaging technology is used in the treatment
and diagnosis of eye diseases, such as diabetic retinopathy and macular holes.
OCT has been approved by the FDA and has since become a highly useful medical imaging technique with a market that may top $800 million by 2012. Ophthalmology is predicted to remain the dominant application, but experts envision OCT applications and products expanding to include cancer detection, cardiology, glucose monitoring, dermatology, and dentistry. In addition, OCT is being developed for intravascular imaging to assess unstable plaque in coronary arteries.
5) Bronchial Thermoplasty (BT): BT involves the controlled application of heat in the lungs to improve pulmonary function and reduce asthma symptoms. This therapy is used to ward off asthma attacks. A recent 300-patient international pivotal trial demonstrated statistically significant improvement in the quality of life for asthma patients. The study followed patients for a year after treatment and reported the thermoplasty group demonstrated reductions in the number of asthma attacks and asthma related emergency room visits. The FDA has recently granted expedited review status for this technology.
6) Ranibizumab: This drug therapy inhibits uncontrolled blood vessel formation in the eye, which is
the primary cause of age-related macular degeneration, and the leading cause of new blindness in older
The drug has since become a clinical and commercial success (more than $2 billion in sales since introduction) and remains the standard of care for age-related macular degeneration; new trials are testing combination therapies with drugs such as volociximab and dexamethasone, which may allow similar or improved outcomes with fewer treatments.
7) Endografting: This is a minimally invasive repair technique traditionally used in cardiology and now
being used to treat vascular disease, including thoracic abdominal aneurysms.
Multiple studies have demonstrated the satisfactory performance of endografting for treatment of atherosclerotic vascular disease in a variety of clinical settings. Endografting has become an accepted and important therapy for the emergency and elective treatment of diseases of the aorta and peripheral vasculature.
8) Targeted cancer therapies: This involves using second generation, small molecule tyrosine kinase inhibitors to block or
modulate disease and provide treatments for advanced cancers, such as renal cell carcinoma.
This technology has been an important advance with several agents in this genre that are either in clinical trials or that have been approved for a variety of cancers including leukemia, pancreatic, breast, lung, and renal. Research is currently being conducted on new drug compounds as well as ways to improve existing drugs through combination therapies and new ways to administer them.
9) Left Ventricular Assist System (LVAS): This is the first implanted ventricular assist device that senses when to increase or
decrease the rate of blood flow. The device takes over most of the function of the left ventricle, and helps generate the force
necessary to propel oxygen rich blood throughout the body.
This concept has become a commercial success with many trial successes. The role of LVAS as a bridge to transplantation for end-stage, medically refractory heart failure has been well established. As a potential extension of this therapy, the NIH has recently established funding for clinical investigation into the use of these devices as an alternative to medical management in less advanced cases of heart failure. The continuous flow ventricular assist device (CVAD), the next generation of ventricular assist systems, was voted #3 on the 2010 Top 10 list. These newer pumps are smaller and potentially more durable and longerlasting than the current generation of pumps.
10) Convection-enhanced delivery of drugs This emerging drug delivery method is being used to administer medication directly
to the site where it is needed, without exposing the rest of the body to a drug's effects.
The current success of this concept is difficult to gauge as a large number of studies have been conducted with conflicting reports of efficacy. However, development is continuing with the aim of improving the overall drug delivery process as well as the catheters needed to implement it. Additional clinical trials can be expected in the future while the medical industry tries to advance this concept.