Now that we are nearly a month into 2013, it’s time to reset our horizon scanning efforts and prepare ourselves for the year ahead. Last year was exciting for the neurosciences community. Several artificial discs and stroke devices were approved by the FDA, the debate about the efficacy of spine surgery continued, and new criteria for comprehensive stroke center certification was released.
It’s easy to imagine that 2013 will come with a host of new technological and programmatic developments across the year. To help understand the evolving product pipeline in neurosciences and spine, I've outlined what we believe are the top six technological trends to watch for across 2013.
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Up to 64% of Americans suffer from sleep-related disorders, such as obstructive sleep apnea, daytime sleepiness, and insomnia. Despite high prevalence of sleep disorders, where the top sleep problems afflict 50 million people, the diagnosis of sleep disorders remains severely underpenetrated. According to the National Sleep Foundation, an estimated 3 million people receive a diagnostic test for sleep disorders in 2009, which is only a fraction of the total patient population that could benefit from such a test. Many patients are unaware that they suffer from a sleep disorder that diminishes their productivity, while others do not want to spend a night in a hospital's sleep laboratory for diagnosis as it is uncomfortable and foreign to them.
In this environment, interest around portable sleep monitoring has increased. Portable sleep monitoring systems are designed to be used in lieu of in-lab polysomnography tests for the diagnosis of obstructive sleep apnea and other disorders.
This week, Advanced Brain Monitoring announced that it will submit a 510(k) application for its Sleep Profiler portable sleep monitoring system. Worn on the patient's forehead, Sleep Profiler uses electroencephalography (EEG) sensors to measure the brain's electrical activity and actigraphy technology to measure sleep stages while the patient sleeps at home. The system also includes a microphone and pulse rate sensor to measure snoring, heart rate, and other physiological activity. The data collected can be accessed on computers and used to diagnose and direct treatment for daytime sleepiness, insomnia, and depression.
Sleep Profiler goes beyond current portable sleep monitoring devices in that it can be used to diagnose sleep conditions other than obstructive sleep apnea. Once it gains 510(k) approval, Sleep Profiler will complement Advanced Brain Monitoring's other portable sleep test, ARES, which is used for the diagnosis of obstructive sleep apnea. Meanwhile, other products in the company's pipeline include Apnea Guard, a mouth guard intended to treat sleep apnea and snoring, and Night Shift, a neck band that prevents patients from sleeping on their backs and exacerbating sleep apnea symptoms.
With a market for portable sleep monitors developing and vendors introducing several products, focus now is on the clinical efficacy of portable monitors over in-lab tests. Also, reimbursement for these devices still needs to be determined. Sleep Profiler, for example, costs between $3,000 and $7,000, and securing both Medicare and private reimbursement for these tests will be key for physicians (and patients) to adopt it.
A few weeks ago we posted about a novel device in the treatment of sleep apnea. Manufactured by ImThera Medical, the technology uses an implantable pulse generator that sends electrical signals to the HypoGlossal Nerve to control the airway of patients with obstructive sleep apnea. Interestingly, two other companies have similar investigational devices. Inspire Medical will begin a 100-person trial this month for its Inspire II system, while Apnex Medical reported initial first-in-man results last spring for its HGNS system.
Some see the technology as a solution without a problem. As mentioned in the previous posting, continuous positive airway pressure (CPAP) has long been considered the gold standard therapy for sleep apnea.The most recent issue of the journal Sleep provides further evidence for the strong role that CPAP should be playing for patients. The issue publishes data from a new study of 59 patients showed that in little as three weeks, continuous use of CPAP significantly reduced fatigue and increased energy in patients with obstructive sleep apnea.
The case for CPAP as a therapy for obstructive sleep apnea has a solid foundation of clinical and practical evidence. In our recent research, however, leading sleep physicians emphasized that what is needed today is a better understanding of the correlation between sleep apnea and other chronic diseases and how the management of sleep conditions can impact the management of those common comorbid conditions. The big ones here are congestive heart failure (CHF) and diabetes: over 70 percent of patients with those conditions suffer from sleep apnea as well.
The correlation of these diseases have been pretty well proven. The Sleep Heart Health Study demonstrated an increased risk of heart failure in patients with obstructive sleep apnea. However, how to manage these patients and have optimal clinical outcomes is still very much an open question.
As providers continue to look closer at disease management and how best to manage chronic diseases effectively, these questions will be increasingly important. What technologies provide the best, most cost effective therapy will be a corresponding debate. While today industry may be looking at developing premium high-tech implantable devices, in the end a simpler, more comfortable version of CPAP could prove to be the best solution, especially if it is found that the therapy also improves outcomes for CHF and other common comorbid conditions.
Neurostimulation--including such modalities as deep brain stimulation (DBS), vagal nerve stimulation (VNS), and spinal cord stimulation (SCS)--has always been an area of incredible promise, though one that does not always meet its expected markets. The excitement that new devices or new indications for existing devices generate can be substantial, even if only because of the ambition of the developers. Products that first started entering the marketplace over a decade ago to treat movement disorders have branched into a wide expanse of diseases: epilepsy, Azheimer's, obsessive-compulsive disorder (OCD), depression, chronic pain, even urinary incontinence. Though not all of these have approved devices available in the United States, the list of trials continues to grow.
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