The list is made up of devices, including a handheld optical scan for melanoma; drugs; diagnostic tests, such as 3D mammography; and a government program that financially rewards patients for improving their health.
1. Bariatric Surgery for Control of Diabetes
Exercise and diet alone are not effective for treating severe obesity or Type 2 diabetes. Once a person reaches 100 pounds or more above his or her ideal weight, losing the weight and keeping it off for many years almost never happens.
While the medications we have for diabetes are good, about half of the people who take them are not able to control their disease. This can often lead to heart attack, blindness, stroke, and kidney failure.
Surgery for obesity, often called bariatric surgery, shrinks the stomach into a small pouch and rearranges the digestive tract so that food enters the small intestine at a later point than usual.
Over the years, many doctors performing weight-loss operations found that the surgical procedure would rid patients of Type 2 diabetes, oftentimes before the patient left the hospital.
Many diabetes experts now believe that weight-loss surgery should be offered much earlier as a reasonable treatment option for patients with poorly controlled diabetes —and not as a last resort.
2. Neuromodulation Device for Cluster and Migraine Headaches
The sphenopalatine ganglion (SPG) nerve bundle — located behind the bridge of the nose — has been a specific target for the treatment of severe headache pain for many years.
Researchers have invented an on-demand patient-controlled stimulator for the SPG nerve bundle. This miniaturized implantable neurostimulator, the size of an almond, is placed through a minimally invasive surgical incision in the upper gum above the second molar.
3. Mass Spectrometry for Bacterial Identification
Even in this age of advanced medical technology, identification of bacteria growing in culture can still require days or weeks.
However, clinical microbiology laboratories throughout the world are now implementing new mass spectrometry technology to provide rapid organism identification that is more accurate and less expensive than current biochemical methods.
Using one of the two MALDI-TOF mass spectrometry systems currently available in the United States provides more accurate identification of bacteria in minutes — rather than days.
4. Drugs for Advanced Prostate Cancer
In the past two years, five new drugs have been approved for advanced prostate cancer: sipuleucel-T, denosumab, abiraterone, cabazitaxel, and enzalutamide. A sixth, radium-223 dichloride, is expected to be approved later this year.
Significant progress has been made in treating advanced prostate cancer, not only by greatly increasing patient survival, but also by halting the progress of this disease.
Many in the prostate cancer research community now believe that these drugs, and others coming from the prostate cancer therapeutic pipeline, will one day help make advanced prostate cancer a chronic disease that’s successfully managed with a routine of daily medication, lifestyle modification, and regular checkups.
5. Hand-held Optical Scan for Melanoma
A new FDA-approved handheld office device assists dermatologists in identifying skin lesions that have characteristics of melanoma.
Without cutting the skin, the device—which uses imaging technology created by the military for guided missile navigation—is placed on the skin over the mole. Special lights of 10 specific wavelengths are shined on the skin, and the computerized system rapidly visualizes the micro-vessel structure of the lesion just below the skin’s surface.
The device then uses sophisticated algorithms that objectively analyze the lesion. Next, the device compares the image findings it has just developed to a database of 10,000 archived images of melanoma and other skin diseases. In less than a minute, an assessment of the skin lesion is given and the dermatologist can then decide on possible next steps.
In a clinical trial of 1,300 patients, the largest study ever conducted in melanoma detection, the device detected 98% of the melanomas, while missing fewer than 2% of these early cancers.
6. Femtosecond Laser Cataract Surgery
Unlike a surgical blade that cuts, a femtosecond laser separates tissue by ablating and cleaving it. The novel FDA-approved bladeless cataract procedure is now revolutionizing surgery by making it more predictable and accurate, allowing surgeons to make smaller, more precise incisions. It also requires less energy time inside the eye, causes less inflammation, and offers more stability when implanting a new lens.
A femtosecond is one quadrillionth of a second. This is the super-fast amount of time that numerous laser pulses of near infrared light are used by a surgeon in this new cataract procedure. The femtosecond laser helps make a perfect circular hole in the lens capsule, splits the lens into sections, and then softens and breaks up the cataract. The damaged lens is removed using ultrasound and an intraocular lens is then implanted. The device has already been used successfully in ophthalmology, particularly for LASIK (Laser In-Situ Keratomileusis) refractive surgery.
7. Ex Vivo Lung Perfusion
Experts believe that as many as 40 percent of previously rejected donor lungs may now be suitable for transplantation thanks to a new approach called ex vivo — outside the body — lung perfusion. This novel “lung washing” procedure can reverse lung injury in many donor organs deemed unsuitable and allow for transplantation.
In this new pioneering procedure, the damaged lungs are removed from a donor, placed in a bubble-like transparent chamber, and connected to a cardiopulmonary pump and a ventilator.
Over a four- to six-hour period, the lungs are then repaired and assessed. Special proprietary fluids are forced through the blood vessels and nutrients are used to re-nourish the lungs as they inflate and deflate as oxygen is pumped through. When necessary, targeted medications are introduced to clear infections. Once determined as being viable, they are ready for immediate transplantation
Ex vivo lung perfusion — which is approved in Europe and Canada, and is now undergoing a major multicenter clinical trial in the United States — has the potential to significantly increase the number of available lungs as the reconditioning process is adopted, refined, and improved at multiple transplant centers. This increased availability of quality-tested donor lungs is going to make a huge difference to the 100,000 American patients with severe breathing problems who now wait on the lung transplant standby list.
8. Modular Devices for Treating Complex Aneurysms
Unfortunately, as many as 20 percent to 40 percent of people with aortic aneurysms have anatomies that are not suitable for the grafts that are currently marketed, nor are they candidates for the more demanding open surgical repair procedure.
However, thanks to a new innovative fenestrated stent graft system, surgeons can now treat patients with these complex aneurysms without having to take detailed measurements and then wait for weeks, sometimes months, for the customized endografts to be delivered.
The FDA recently approved a multi-center trial of the modular stent device for aneurysms that come close to the renal artery. The device incorporates individual branches to both renal arteries and the superior mesenteric artery.
Taken “off-the-shelf” by a surgeon, it can be used for both elective and urgent cases involving the renal arteries. The new modular stent graft system offers a significant reduction in morbidity and ICU stay, but more importantly, it allows an application of life-saving technology to high-risk patients who never could have been treated for their aneurysms.
9. Digital Breast Tomosynthesis (DBT)
Tomosynthesis, or 3D mammography, is a diagnostic technology that was approved by the FDA in 2011. Breast tomosynthesis does not currently replace traditional two-dimensional mammography testing, but instead, it is performed along with the conventional mammogram to provide a more accurate view of the breast
During the tomosynthesis portion of the exam, the x-ray arm of the machine makes a quick arc over the breast, taking dozens of images at a number of angles. Later combined to make a three-dimensional rendering of the entire breast, the images can be viewed by a radiologist at a computer workstation to check areas of concern. If cancers are found when they are small, treatment options are generally less traumatic and the chance for cure is greater.
What 3D technology offers doctors and mammography technicians is a much greater opportunity to discover small cancer cells obscured by surrounding tissue that may not be visible on standard mammograms. This is particularly the case in women with dense breasts, in which tumors often escape detection. Preliminary study results of 25,000 women reported a 47% increase in cancer detection when tomosynthesis was used.
3D mammography also reduces the much-feared callbacks for women. Due to a lack of diagnostic clarity, one in 10 women typically is asked to return for additional testing following a routine mammogram screening that has raised concern. However, in a recent study of 7,500 women, the recall rate of women screened with breast tomosynthesis and traditional mammography combined was 6.6% compared to 11.1% for traditional mammography alone.
10. Health Insurance / Medicare Program / Rewards for Better Health
The bipartisan Medicare Better Health Rewards Program Act of 2012 has been presented to Congress as a way to improve healthcare and control costs for Medicare participants. The goal of the program is to encourage people to take a more active role in their well being by developing and maintaining healthy habits.
The Better Health Rewards Program is part of a growing wellness revolution in American healthcare that is designed to give everyone achievable health goals and a detailed plan to reach them, as well as financial incentives to keep motivated and follow through with the various health strategies.
The three-year program uses the annual wellness visits Medicare already subsidizes to determine and measure improvements in six key areas of health: body mass index, diabetes indicators, blood pressure,cholesterol, vaccination status, and use of tobacco products.
1. Catheter-Based Renal Denervation to Control Resistant Hypertension: Today, one in three adult Americans has hypertension, which puts them at significant risk for strokes, heart attacks and kidney failure. In fact, hypertension is the No. 1 risk factor for death in the world. Now, a new 40-minute catheterization procedure, called renal denervation, is approaching resistant hypertension in a new way – by targeting the renal sympathetic system, which consists of the small nerves that carry signals between the brain to the kidneys. Disruption of these nerve fibers has resulted in improved blood pressure levels, while also showing promise in treating chronic kidney disease, insulin resistance, and heart failure.
2. CT Scans for Early Detection of Lung Cancer
3. Concussion Management System for Athletes
4. Medical Apps for Mobile Device
5. Increasing Discovery with Next-Generation Gene Sequencing
6. Implantable Device to Treat Complex Brain Aneurysms
7. Active Bionic Prosthesis: Wearable Robotic Devices
8. Harnessing Big Data to Improve Heath Care:
9. Novel Diabetes Therapy: SGLT2 Inhibitor
10. Genetically Modified Mosquitoes to Reduce Disease Threat
Four major criteria for selection-
* Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery).
* Have a high probability of success.
* Be on the market or close to being introduced.
* Have sufficient data available to support its nomination.
1. New molecular imaging biomarker for early detection of Alzheimer’s disease Currently, positive diagnosis of Alzheimer’s is only possible upon autopsy. But a radioactive molecular imaging compound called AV-45 and a PET scan can allow doctors to “see” inside patients’ brains to detect beta-amyloid plaques, the tell-tale signature of Alzheimer’s.
2. Anti-CTLA-4 drug (ipilimumab), a targeted T-cell antibody for metastatic melanoma
3. First therapeutic cancer vaccine approved by the FDA
4. JUPITER study and statins for healthy individuals
5. Hepatitis C protease-inhibiting drugs
6. Telehealth monitoring for heart failure patients
7. Transoral gastroplasty, or TOGA
8. Exhaled nitric oxide (NO) breath analysis for diagnosing asthma
9. Oral disease-modifying treatment for multiple sclerosis
10. Capsule endoscopy for diagnosis of pediatric GI disorders
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