Where Are They Now? Top 10 for 2012

Where Are They Now? Top 10 for 2012

Every year, Cleveland Clinic releases its list of the Top 10 Medical Innovations for the year that follows. Recently approved or up-and-coming in the space, these solutions grabbed the attention of our thought leaders for the waves they were making in medicine. But what happens to these innovations after they’re rolled out on stage? Join us as we move back through time and ask of the Top 10 Medical Innovations, ‘Where Are They Now?’

#1: Catheter-Based Renal Denervation to Control Resistant Hypertension

The renal sympathetic system, which consists of the small nerves that carry the signal from the brain to the kidney and back from the kidney to the brain, plays an important role in the regulation of blood pressure levels. Researchers have now found that disruption of these nerve fibers has a positive effect on blood pressure levels. In 2011, renal denervation was a new 40-minute procedure performed in a hospital catheterization laboratory in which a catheter-based probe was introduced through the femoral artery in the upper thigh and threaded up into the renal artery near each kidney. In 2011, in the recent Symplicity HTN study – the first human randomized controlled trial of renal denervation – 54 patients received oral medications, and 52 underwent renal denervation. After six months, 39 percent of patients receiving renal denervation reached target blood pressure and overall, 50 percent of patients showed a measurable benefit from the intervention. Three months later, lowered blood pressure remained stable for all study subjects. But in 2014, the initial US study, SIMPLICITY HTN-3, failed to meet its efficacy endpoints – an error that has been chalked up to various missteps.

WATN: The development of multielectrode radiofrequency and new-generation ultrasound renal nerve ablation systems has improved the reproducibility and completeness of RDN, and in the context of rigorously designed sham-controlled trials, the blood pressure-lowering effect of RDN is now consistently demonstrated. Denervation of small branches and accessory arteries remains challenging, but the issue is being partly solved with the design of smaller diameter catheters. Still, despite these technical improvements, the overall benefit of RDN remains modest, roughly equivalent to that of one antihypertensive drug, reliable noninvasive predictors of blood pressure response to RDN have not been consistently identified,8 and the potential impact of anatomic variability on the results of RDN remains to be properly addressed.

#2: CT Scans for Early Detection of Lung Cancer

In 2011, lung cancer was the most common cause of death from cancer among American men and women. According to the American Cancer Society, more than 220,500 new cases of lung cancer were diagnosed annually and it was estimated that 157,000 Americans would of lung cancer in 2011.Death rates remained elevated as there was no effective screening method for early detection of lung cancer. Doctors typically did not recommend general screening for lung cancer in smokers and former smokers as standard x-rays were not sensitive enough to locate small tumors, nor did they help decrease death from lung cancer. Medicare and most insurance companies did not cover lung cancer screening. This trend changed with the introduction of low-radiation-dose spiral computed tomography (spiral CT) – a high-tech scan that generated a series of detailed cross-sectional images of the lungs, creating a three-dimensional image. More than 53,000 men and women aged 55 to 74 who were heavy smokers and former heavy smokers participated in a multicenter National Lung Screening Trial (NLST) of spiral CT when it was fairly new. The study reported 20 percent fewer lung cancer deaths among older, current or former heavy smokers screened with CT compared with chest x-ray. This is the first study to show that screening for lung cancer could save lives.

WATN: In 2013, the US Preventative Services Task Force (USPSTF) updated the eligibility criteria for yearly screenings to patients between the ages of 55-80, have had at least 30 pack-years of smoking history and have smoked in the past 15 years to balance between the benefits of early detection and accompanying radiation risks. The new guidelines recommend that screening only be offered in academic medical centers or other sites with specialized radiologists on staff. The scans, which are often offered for as low as $100, are still not covered by insurance. After some debate, in February 2015 Medicare began providing coverage for all eligible patients for yearly, low-dosage CT scans. From work done in 2016, CT lung screening has been shown to reduce lung cancer deaths by as much as 20%. In 2021, the USPSTF’s recommendations for screening are even less conservative, broadening the age range by five years (50-80) and reducing the pack-year number to 20 from 30.

#3: Concussion Management System for Athletes

In 2011, The U.S. Centers for Disease Control and Prevention calculated almost four million sports- and recreation-related concussions occur each year – exacting a heavy toll with about 235,000 hospitalization and 50,000 deaths annually. Estimates suggested that up to 40 percent of football players experienced a concussion annually, with the majority of these sports brain injuries going unreported, unrecognized, and unmanaged. Entering the scene that year was a suite of patient management tools instantly detecting brain injuries at the moment of contact, and providing patient-specific guidance about when athletes could return to play. One such novel concussion management tool included a special assessment to establish an athlete’s baseline cognitive and motor skills, and a specially instrumented mouthguard dosimeter to be worn during practice or games. Following a traumatic brain injury event detected by the mouthguard, the cognitive assessment was to be retaken – providing the team doctor or athletic trainer the important information needed to manage and gauge the condition of the athlete in question, and their eventual return to physical activity.

WATN: Concussion worries still loom large in the sports world from professional athletes, to grade school and high school-aged kids. In the past few years, more than 3,300 players have sued the National Football League, charging that not enough was done to inform them of the dangers of concussions in the past, or to take care of them today. For school-aged children, there is now a loud call for school systems to have mandatory, science-based concussion management systems, developed in accordance with national guidelines. In 2017, a new grant was announced, funding programs of up to $25M for research on traumatic brain injury and chronic traumatic encephalopathy – a progressive degenerative disease found in individuals with multiple concussions.

It is hoped that continued funding of research projects in the area of concussion management will improve treatment and prevention programs. As for management technology, specialty dosimeter mouth guards like those triggering the Top 10 nomination are commercially available – as are a variety of web applications for informal concussion diagnosis.

#4: Medical Apps for Mobile Devices

Medical Apps for mobile devices are now considered a standard practice, but in 2011, one could argue they were just coming onto the scene. Though largely uncharted and unregulated, our thought leaders knew they were poised for significant impact.

WATN: As mobile devices and applications have become more user-friendly, affordable and powerful, the appeal to healthcare providers has grown exponentially. The global mobile market size was valued at $45.7B in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 17.6% from 2021 to 2028. Growing penetration of smartphones, internet connectivity, and supportive government initiatives are among the key factors driving the market growth. Amid the COVID-19 crisis, the global market for mobile medical apps reached an estimated $4.2B. The most successful apps in the space are those that provide needed services, and make doctors and patients more efficient. With the enormous potential impact on consumers, the FDA began regulating mobile applications that were considered a ‘device’ and has recommended guidelines for the other apps to help consumers better their health in the safest way possible.

#5: Increasing Discovery with Next Generation Gene Sequencing

The massively parallel sequencing technology known as next-generation sequencing (NGS) has revolutionized the biological sciences. With its ultra-high throughput, scalability, and speed, NGS enables researchers to perform a wide variety of applications and study biological systems at a level never before possible. In the period leading up to 2011, next-generation sequencing technology improved at an extraordinary rate, with new warp-speed sequencers making it feasible for researchers to conduct experiments once considered too expensive or just simply impossible. Enamored with its ability to drop the cost of sequencing a human genome by a factor of more than 10,000, our experts aw the technology’s broadening potential.

WATN: The field of next-gen sequencers is expanding rapidly and these devices have become go-to items in the armamentarium of researchers. Pathology laboratories that utilize these silicon-based machines now offer clinicians the ability to detect and characterize disease at earlier stages when a cure is still possible. The global next-generation sequencing market size was valued at $3.99B in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 14.4% during the forecast period 2021-2028. Genome sequencing has been used to understand the spread of COVID-19 and has the potential to understand the impact of interventions and help guide treatments in the future.

#6: Implantable Device to Treat Complex Brain Aneurysms

An aneurysm in the brain, also called a cerebral aneurysm or an intracranial aneurysm, is a weakened area in the middle layer of the wall of a blood vessel in the brain that causes an abnormal ballooning or widening. When a small aneurysm is discovered, it can be treated with a major surgical procedure in which the skull is opened and special clips are used to clamp blood flow to the aneurysm. It can also be treated using a catheter and threading metallic coils into the blood vessel in the brain that contains the aneurysm. This causes the blood vessel to clot, effectively destroying the aneurysm. Unfortunately, these two methods can’t be used for large and difficult-to-treat aneurysms, particularly those an inch or more in diameter with a wide neck (opening). These aneurysms are some of the most complex and dangerous and remained a significant unmet clinical need until 2011. A minimally-invasive procedure to safely and effectively treat these aneurysms came by way of implantation of a recent FDA-approved device. Consisting of a flexible braided mesh tube made of platinum and nickel-cobalt chromium alloy, this device was delivered by catheter and used to block off large, giant, or wide-necked aneurysms in the damaged internal carotid artery, with over 90 percent total obliteration rates at 12 months consistently confirmed in international studies.

WATN: An updated version of this technology with an advanced delivery system was approved by the FDA in February 2015 to increase the accuracy and improve control during the procedure. Several other advanced versions of this technology have entered the market, with the most recent receiving FDA approval in 2019.

#7: Active Bionic Prosthesis: Wearable Robotic Devices

For centuries, wood and metal were the basic materials used for prostheses, and they were held to the body with leather attachments. Thanks to the remarkable advances in prosthetics research, space-age plastics and carbon fiber composites, which are much stronger and lighter and more durable, have been engineered to become enhanced limbs. But 2011 saw the introduction of computerized bionic leg devices with microprocessors and computer chips that could rival the functionality provided by biological limbs. Recent clinical studies of the technology had reported that lower-limb amputees who wore the active prosthesis bionic lower leg system were able to walk at the same speed and with the same metabolic energy as their peers with intact biological limbs. By contrast, traditional carbon fiber lower limb prostheses had proven incapable of adapting to various terrains and walking velocities while requiring the amputee to expend significantly more energy—from 10 to 30 percent—than non-amputees. Previously available only to military personnel, wearable robotic devices were making their way into the lives of more consumers through a network of select prosthetics providers around the country.

WATN: Technology in newer prosthetics is advancing rapidly. The next frontier is to create active bionic prosthetics for more detailed and delicate movements performed by the upper limbs and hands. Overall, the bionic limbs market is growing at a high 11% during the forecast period 2021-2027. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market.

#8: Harnessing Big Data to Improve Healthcare

Big data is becoming big business as more American hospitals digitize patient records and then analyze them to discover particular patterns that can help improve care and outcomes. With a government push and financial incentive to adopt electronic medical records, hospitals and researchers alike are using this information to find clues to the initiation of various cancers and diseases like multiple sclerosis, and to look for possible links between particular neighborhoods and the prevalence of certain medical conditions.

WATN: With new technologies such as wearables, applications, and the almost universal use of digital health records, big data analytics have only continued to grow. Its value is almost unable to be estimated, but deeply understood by health innovators around the world.

#9: Novel Diabetes Therapy: SGLT2 Inhibitors

Diabetes management often entails the use of multiple drugs for optimal control. While other diabetes mediations typically boosted insulin levels or made the body more sensitive to insulin, the novel SGLT2 inhibitors worked independently of the hormone, leaving the door open for possible use as an add-on therapy. In 2011, many SGLT2 inhibitors were in major clinical trials here and abroad, with one awaiting FDA approval. Study results had reported that the drugs were very effective after a few months of treatment and well-tolerated, even among refractory patients. Responding well to this new therapy had the ability offer hope for much-improved diabetes management in an increasingly at-risk population.

WATN: The SGLT2 inhibitors have been extensively studied in industry-supported clinical trials and were found to be safe and effective at improving glucose control in adults with type II diabetes. This research has culminated in FDA approval of several drugs for treatment of type II diabetes. The first SGLT2 inhibitor to be FDA-approved was canagliflozin (marketed as Invokana®) in March 2013, followed by the approval of dapagliflozin (marketed as Farxiga®) in January 2014 and empagliflozin (marketed as Jardiance®) in August 2014. These medications provide new tools to help control blood glucose levels in adults with type II diabetes.

Building on the successful use of existing SGLT2 inhibitors in people with type II diabetes, more research is being done on this class of medications. SGLT2 inhibitors provide a significant reduction in blood glucose levels, but they do not reduce blood glucose to healthy levels in all people who have been given these medications. Thus, some compounds that inhibit both SGLT2 and SGLT1 are under investigation to increase glucosuria even more than can be achieved with SGLT2 inhibitors alone. Additionally, several new SGLT2-specific inhibitors are in pre-clinical development, and some have been approved for type II diabetes treatment in other countries. Ongoing studies will provide information about whether SGLT2 inhibitors are safe and effective in people with type I diabetes.

#10: Genetically Modified Mosquitos to Reduce Disease Threat

With the fear of dengue fever (nicknamed "break-bone fever") and its intense joint pain, cities in southern Florida and also in Brasilia, Brazil, were considering the use of genetically modified mosquitoes to eliminate the disease-causing pests. More than 400,000 cases of dengue were registered in Brazil in 2012, while no cases had been recorded in the Florida Keys in 2012. The plan was to release genetically modified mosquitos in the Florida Keys to combat the spread of dengue fever and chikungunya. While these GM mosquitos had already been released in the Cayman Islands, the still largely unknown effects of releasing genetically modified insects made this decision an extremely controversial one.

WATN: With the 2016 outbreak of the Zika virus, genetically modified mosquitos again became popular, ultimately leading to the FDA approval of their use. The FDA’s released environmental assessment gives the green light for releasing modified Aedes aegypti mosquitos, known to transmit a wide variety of illnesses to humans, including chikungunya and dengue fever. In February of 2018, a similar technique called “population suppression” was employed. Using CRISPR-based gene editing scientists were able to alter mosquitos in a way that would suppress unwanted insect populations and prevent the further spread of mosquito-carried viruses.

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