An artificial pancreas to help diabetics. A pacemaker for sleep apnea. Gene therapy for blindness. These are some of the innovations that will enhance healing and change healthcare in the coming year, according to a distinguished panel of doctors and researchers.
Cleveland Clinic today announced the Top 10 Medical Innovations of 2018 at a multi-media presentation that capped off the 2017 Medical Innovation Summit. Now in its 15th year, the annual Medical Innovation Summit is organized by Cleveland Clinic Innovations, the development and commercialization arm of Cleveland Clinic.
The list of up-and-coming technologies was selected by a panel of Cleveland Clinic physicians and scientists, led by Michael Roizen, M.D., Chief Wellness Officer at Cleveland Clinic.
Here, in order of anticipated importance, are the Top 10 Medical Innovations of 2018:
1) Hybrid Closed-Loop Insulin Delivery System
Hailed as the world’s first artificial pancreas, the hybrid closed-loop insulin delivery system helps make Type 1 diabetes more manageable. Approved by the FDA in late 2016, this new technology enables direct communication between the continuous glucose monitoring device and insulin pump to stabilize blood glucose at an unprecedented level. The technology replaces the “open loop” concept that requires patient to use the information from their continuous glucose monitor to determine how much insulin to inject.
The market is projected to be officially disrupted in 2018 as more patients demand the technology and more insurers reimburse for the system. Experts are also optimistic that the outcomes demonstrated in Type 1 diabetes will accelerate a similar product for the millions of Type 2 diabetes patients in the near future.
2) Neuromodulation to Treat Obstructive Sleep Apnea
Sleep apnea, the most common sleep disturbance, impacts 21 million Americans and can lead to high blood pressure, heart disease and stroke. While continuous positive airway pressure device, (C.P.A.P.) is the gold standard treatment, it is estimated that more than 40 percent of sleep apnea patients refuse to wear the device.
Companies are now marketing an implant that delivers stimulation to open key airway muscles during sleep. Controlled by a remote or wearable patch, the technology acts like a pacemaker, helping to synchronize the intake of air with the action of the tongue using a breathing sensor and a stimulation lead powered by a small battery. These neuromodulation systems have had positive results in clinical testing and are predicted to be the technology to deliver a better night’s sleep to more patients and spouses, and healthier communities nationwide.
3) Gene Therapy for Inherited Retinal Diseases
In 2018, the FDA is anticipated to approve a new gene therapy for inherited retinal diseases. The ability to deliver a new gene to targeted cells in the body via viral “vectors” is expected to provide visual function improvements in some patients with forms of Leber congenital amaurosis and retinitis pigmentosa.
Caused by biallelic RPE65 mutations, these rare genetic conditions result in progressive vision loss and blindness. Currently, there are no FDA-approved treatments for RPE65-mediated eye diseases. This innovative gene therapy delivers a new “normal” working copy of the gene that results in a functional protein. Researchers place this gene inside a modified virus and this “vector” delivers it to retinal cells.
In 2017, the FDA awarded orphan drug status to RPE65 gene therapy, and last week a panel of U.S. health advisers recommended approval for this innovative approach. Experts believe an approval could lead to more gene therapies getting orphan drug and breakthrough status.
4) The Unprecedented Reduction of LDL Cholesterol
Low-density lipoprotein (“LDL”) cholesterol is known as bad cholesterol, bringing about fatty deposits that can clog arteries. With certain new drug combinations, LDL levels are reduced by 75 percent. While this stat is remarkable, many patients and doctors wonder how low is too low?
A number of trials have been in progress recently testing this theory. So far, the floor has yet to be found. New studies reported a 20 percent reduction in the risk of cardiovascular death, myocardial infarction or stroke for patients who took statins combined with a new class of cholesterol-lowering drugs (PCSK9 inhibitors) to reach ultra-low LDL levels.
So what does this mean? Doctors now have the tools and the research to take the fight to LDL cholesterol. With over 400,000 coronary disease deaths and 102 million Americans living with high cholesterol levels, these new strategies hold the promise to turn the tide in 2018.
5) The Emergence of Distance Health
Extending the healthcare environment to the patient’s home has been a goal for decades. Removing geographic barriers to care can result in timelier, more efficient and more optimal outcomes as well as significant cost savings. Distance health technologies (known as telehealth) can enable care for both the physically challenged and those most vulnerable to infection.
Due to an increase in connectivity through mobile technology and consumer demand, hospitals are getting ready for widespread adoption in 2018. 90 percent of healthcare executives reported to have or are currently building a telehealth program. Reports also predict 7 million patient users in 2018, a 19-fold increase from 2013.
These technologies are also expanding beyond the simple two-way video platform. More patients are now equipped with attachable devices that record and report medical information to doctors to monitor their condition. Over 19 million patients are projected to use these remote monitoring devices in 2018. With momentum building, experts believe that the emergence and acceleration of distance health technologies and services are assured in 2018.
6) Next Generation Vaccine Platforms
Developing one vaccine is estimated to cost $200 million and take at least 10 years. The toughest challenges, however, often lie in timing and delivery. With the recent Ebola and Zika outbreaks, it was clear that the process needs to be expedited to fully curtail an epidemic.
In 2018, innovators will be upgrading the entire vaccine infrastructure to support the rapid development of new vaccines, as well as breaking ground on novel mechanisms to deliver new and existing vaccines to vast populations. For example, innovators are perfecting the use of freeze drying vaccines which can allow shipment to more remote locations. Companies are finding faster ways to develop flu vaccines using tobacco plants, insects and nanoparticles.
At the point-of-care, innovators are thinking outside the syringe. Oral, edible and mucosally delivered vaccines, intranasal vaccines, and vaccine chips are all under development. In 2018, a Band-Aid-sized patch for the flu vaccine is expected to be on the market.
These new ways of developing, shipping, storing and vaccinating are being swiftly connected to stave off current and future diseases and epidemics. With over 21 million hospitalizations and 732,000 deaths in the last 20 years that could have been saved by existing vaccines in the U.S. alone, these new platforms are in a position to keep individuals healthier than ever.
7) Arsenal of Targeted Breast Cancer Therapies
The most full-scale attack on breast cancer is currently underway. The tried-and-true treatment mechanisms – via hormone therapy, chemotherapy and radiation – are still valuable options for prolonging life. But these treatments are often not enough to keep cancer at bay, and can also lead to the collateral damage of healthy cells.
2018 marks the year that targeted therapies are most widely used to treat breast cancer – a disease that kills over 40,000 American women per year. A variety of new targeted treatments, such as PARP inhibitors for patients with specific mutations in BRCA1 or BRCA2, and novel CD K 4/6 inhibitors for ER-Positive/HER-2-negative breast cancer are having positive outcomes in clinical trials. In addition novel HER-2 targeted agents continue to show benefit in this subgroup of HER-2-positive patients. Experts believe the cumulative results from these studies are pointing to an increasing survival rate, and perhaps the eventual end of chemotherapy for a significant population of breast cancer patients.
8) Enhanced Recovery After Surgery
For decades, the pre-and post-surgery routine has been standard for nearly all procedures: No eating before surgery; use pain medications for comfort; and stay in bed during recovery. After substantial growth in hospital readmissions and an opioid epidemic spiraling out of control, innovators are overhauling post-surgery strategies, and delivering impressive results, including ultra-low readmission rates.
Several centers have been developing the concept of “fast-track” or “enhanced” recovery after surgery. Recent research indicates that an ERAS (“Enhanced Recovery After Surgery”) protocol that permits patients to eat before surgery, limits opioids by prescribing alternate medications, and encourages regular walking reduces complication rates and speeds recovery. These protocols can reduce blood clots, nausea, infection, muscle atrophy, hospital stay and more. Patients are also given a post-operative nutrition plan to accelerate recovery, and physicians are using multi-modal analgesia, limiting the use of narcotics.
In 2017 collaborations were formed between surgical societies and large healthcare systems to drive funding and education for hospitals looking to implement the protocols on a larger scale.
9) Centralized Monitoring of Hospital Patients
Hospitals have long struggled with “alarm fatigue,” when busy caregivers become desensitized to the constant noise emanating from cardiac telemetry monitoring systems. Important warning signs can be missed in the din of nuisance pings. Reports indicate that up to 44 percent of inpatient cardiac arrests are not detected appropriately. Consequently, fewer than one in four patients survive an in-hospital cardiac arrest according to the American Heart Association.
Centralized monitoring has emerged as the answer, as part of a “mission control” operation in which off-site personnel use advanced equipment, including sensors and high-definition cameras to monitor blood pressure, heart rate, respiration, pulse oximetry and more. Complex data are assimilated to trigger on-site intervention when appropriate while filtering out many unimportant alarms. In 2016, results from the CMU’s first 13 months of using the standardized criteria were published showing that there’s real hope of reducing rates of redundant or less significant alarms while improving clinical outcomes. The study reported a 93% survival rate of cardiopulmonary arrests among patients for whom the centralized monitoring unit gave advance warnings.
Since then, further innovation has yielded a system that can double the number of monitored patients per technician, improve clinical outcomes, and decrease communication transit times. The results of the “eye in the sky” approach are capturing the attention and imaginations of hospitals around the world.
10) Scalp Cooling for Reducing Chemotherapy Hair Loss
Newly diagnosed cancer patients have a lot to process. For women, the inevitable loss of hair is often one of the hardest. There is a new technology making its way to the U.S. that is looking to eliminate this problem from some patients’ lists of worries.
The practice of “scalp cooling” – which works by reducing the temperature of the scalp a few degrees immediately before, during and after chemotherapy – has been shown to be highly effective for preserving hair in women receiving chemotherapy for early-stage breast cancer. The scalp cooling system was approved by the FDA in May 2017.
For more information on the annual Top 10 Medical Innovations list including descriptions, videos, and year-by-year comparisons visit: http://innovations.clevelandclinic.org/Summit/Top-10-Medical-Innovations.aspx.