Neurologics

Medical Device Monday: Cala ONE's Essential Tremor Device

What happens when experts in the fields of neuroscience, consumer electronics, and data science come together? While your first thought is likely, "the most epic party ever," the correct answer is: they develop a cutting-edge neuromodulation device. Cala ONE, by Cala Health, is a non-invasive, neuroperipheral therapy device that aims to provide transient relief of hand tremors in adults with essential tremor. The device is another success story out of the de novo program at FDA, and was granted marketing authorization this past April (2018). To understand the impact of the device, let’s talk a little more about essential tremors.

Essential tremor (ET), also once known as familial tremor, is a common movement disorder affecting almost 10 million Americans, and millions more worldwide. The condition is often confused with Parkinson’s, and causes rhythmic trembling of the limbs, head, and voice. The constant shaking makes it difficult to perform even the most basic daily activities like eating, drinking, and writing. Although the exact causes and mechanisms of the disorder are unknown, it is believed that they are mostly inherited, and are caused by tremulous activity within a central tremor neural network.

Current treatment options for tremors centralize almost entirely around medications. Some of these medications include beta-blockers and anti-seizure drugs that often have undesirable side effects. In cases where medications fail, alternative treatments like Botox injections or invasive surgical options are used, which can also be just as dangerous as the side effects that come with medication. Cala ONE promises to be a non-invasive, non-pharmacological targeted nerve stimulator for symptomatic relief of hand tremors. The device, which looks quite similar to a fitness tracker or smart watch, delivers patterned electrical stimulation to the median and radial nerves— part of the peripheral nervous system— in the wrist, through the skin.  Two randomized controlled studies, one being an in-clinic study that included 77 participants, and the other an at-home study that included an additional 61 participants, showed marked improvement in those that received treatment stimulation when compared to those that received sham stimulation. Cala ONE is another device in the ever-expanding area of personalized medicine wherein a physician can measure an individual’s tremor using on-board sensors and tailor the treatment according to the patient.

 

Image from mobilehealthnews.com

 

This new device aims to benefit people with ET who might not be able to do things that were once second nature to them. Our abilities to hold someone’s hand, throw a dog a ball, enjoy a home-cooked meal, and write our name are often taken for granted. Thanks to neuroscience, consumer electronics, and data science experts coming together (and likely having an epic party of the minds), this device stands to benefit many people who have been unable to take those actions for granted.

 

Suggested Reading:

  1. FDA de novo Classification Order

  2. Cala Health Website

  3. More information about Essential Tremor

 

Med Device Monday: Nerve Stimulation for Sleep Apnea

Sleep is an essential human function, but one we tend to take for granted until it goes wrong or we're not getting enough of it—much like breathing. Breathing is of course an important part of sleep, and is an involuntary mechanism that our brains take care of even when our minds are elsewhere. But when breathing is impaired through sleep, it can mean more than just annoying snores or restlessness: sleep deprivation can be life-threatening. Sleep is essential to our well-being, supporting and enabling healthy brain-function, emotional wellbeing, memory, and overall physicality. When we sleep, our bodies repair our cells and slowly restore us—literally. Chronic sleep deprivation can lead to accidents & injury, obesity, heart disease, depression, suicide, kidney disease, diabetes, stroke, and more. All that from not catching enough Zs!

FDA recently-approved a medical device that offers an interesting new solution to this problem. Specifically, for central sleep apnea, which is when the brain neglects to properly send signals via the phrenic nerves to keep the diaphragm moving, and in turn keep air moving in and out of lungs. When a person experiences this type of sleep apnea, their heart rate increases while they cease breathing, and once the nerve function kicks back in and tells the diaphragm to move (and thus the lungs to fill), there is a period of rapid breathing—sort of like the body is catching up to get all that oxygen it missed.

Photo from fda.gov.

Photo from fda.gov.

Respicardia Inc.'s device is called Remedē® System. This nerve-stimulating device is an implant that monitors and regulates nerve activity when the patient is asleep. It can either be set to send these pulses at regular intervals, or send them only when it detects that the patient isn't breathing. Although the implant is in the patient around the clock, safeguards are in place so that it is only used when the patient is sleeping. It is also monitored by the patient's doctor. The company says that the device is implanted by a cardiologist using only local anesthesia as needed. A small generator goes under the skin, and the long thin wires are then threaded through veins near the phrenic nerves in order to stimulate them, and in turn the diaphragm. 

Try not to hold your breath while you watch this video:

This device is meant to treat moderate to severe sleep apnea of this specific type. It's important to note that this sleep apnea is different than obstructed sleep apnea, where an airway obstruction causes the disruption in breathing, and for which we have CPAP and BiPAP machines. Every type of sleep apnea is of course problematic and can be life-threatening, and it's cool to see how medicine can really narrow in on specific problems and come up with innovative solutions like these!

 

Further reading:

FDA info on Remede

Remede approval letter

Remede summary of safety and effectiveness

 

Previous Med Device Monday posts on sleep devices:

Help for restless legs

Help for insomnia

Med Device Monday: Wearable Photobiomodulation Devices

This month, we're focusing on devices that are making their way toward FDA approval, but which haven't been approved yet. Last week, we talked about the artificial wombs, how they work, and their implications. 

Are you familiar with TMCx? The Texas Medical Center accelerator is a great place to check out if you're in need of some inspiration in the form of hard-working people who are passionate about how their devices can change lives. Last year, we did the Not Yet Approved month in September, and featured Blümio, a device we learned about via TMCx. 

Today, we're talking about another TMCx-featured device: Aesela. They're wearable photo modulation devices, as the title of this post says. WELP, I think that fully explains it! See you next week! 

Okay, really though, photobiomodulation devices? Yes! And this is so cool. These devices are meant to be worn by patients after certain surgeries and procedures in order to speed and aid healing. They use light energy to affect a series of changes at the cellular level and promote healing. This has they potential to be a game-changer for everything from C-sections to TMJ surgeries to liposuction to wisdom teeth extraction.  

Photo from aesela.com.

Photo from aesela.com.

As the company explains, "PhotoBioModulation is a nonthermal process involving endogenous chromophores eliciting photophysical (i.e., linear and nonlinear) and photochemical events at various biological scales. This process results in beneficial therapeutic outcomes including but not limited to the alleviation of pain or inflammation, immunomodulation, and promotion of wound healing and tissue regeneration."

One of my employees has had several orthognathic surgeries. That's where they break your jaw(s) and put you back together again. She was excited to see this device, and said, "This would have been a huge blessing to me during my recovery. As you can imagine, the healing process for a surgery like that is not pretty. It's long, uncomfortable, and full of bruising, swelling, and pain like you can't imagine. I had no idea the human body could expand that much! Having relief from all of the swelling, and having the tissues possibly heal quicker, would have made the whole process, well, not enjoyable, exactly, but certainly much better. And less swelling and quicker healing would also have meant I could have gotten more nutrition more quickly to help aid the healing process. Can't say I recommend a liquid diet for getting in fighting shape."

In addition to the points she brings up, some of the testimonies on Aesela's website mention that using the device also resulted in patients using fewer narcotics post-op, which is certainly a bonus. All in all, this sounds like a win to me. I'm excited to follow this device!

 

Further reading:

About TMCx

TMCx welcomes new medical device class

 

 

 

Med Device Monday: Quicker Diagnosis for Concussion

Concussions have been a bit of a hot topic over the past few years. From little leagues to pro athletes, and even to the silver screen, more attention is being paid to these and other Mild Traumatic Brain Injuries (MTBI)—and with good reason. 

Mild brain injuries can be anything but mild. This category of trauma includes concussions (the most common type of MTBI), and symptoms can include pain and headache, nausea, vomiting, fatigue, drowsiness, changes in sleep patterns, and problems with balance or vision. While there is no treatment for MTBI, diagnosis means the patient can rest and avoid activities that will worsen the damage while giving it time to heal. Multiple concussions in a short amount of time can lead to longterm problems, like Alzheimer's and dementia, but can even cause immediate death.

Unfortunately, it previously hasn't been easy to diagnose MTBI. Some are visible on electroencephalogram (EEG), and others via computerized tomography (CT) scan. CT scans use low doses of radiation to see inside the body, while EEGs do not. This is where Brainscope comes in! Brainscope explains that, "According to recent publications, 95% of all head-injured patients who go to the Emergency Department present with mild symptoms. The vast majority of these head-injured patients receive a CT scan, of whom over 90% are CT negative for structural brain injury, creating needless radiation exposure to patients. The Ahead 300 has the potential to significantly reduce costs and wait times associated with hospital visits and unneeded CT scans." Ahead 300 also allows for a diagnosis on the spot, reducing the need for multiple medical appointments, and along with that, the risk that those appointments might get missed and the injury never be diagnosed.

Photo from brainscope.com.

Photo from brainscope.com.

Using a blend of EEG and proprietary technology, a single-use headpiece is attached to a handheld device. Algorithms are used to analyze brain wave patterns and spot anomalies, resulting in a diagnosis.

In announcing FDA's clearance, Brainscope also shared that, "The Ahead 300 was developed in partnership with the U.S. Department of Defense through six research contracts, and with over 20 clinical studies at 55 sites and 16 peer-reviewed publications." Check out the clinical trial that helped demonstrate the Ahead 300's improved accuracy and expanded indications over the Ahead 200 (expanded injury time window and expanded patient age range).

Med Device Monday: Treatment for Cluster Headache Pain

When it comes to debilitating headaches, migraines often get top billing. But cluster headaches can be even more painful, just as tough to manage, and equally as disruptive to everyday life.

Often concentrated in one area—like around the eye—cluster headaches tend to come on swift and strong. They're known to wake people in the middle of the night with brutal pain. They tend to come in fits and starts, with 'cluster periods' lasting anywhere from days to months and then the pain recedes. Time between these cluster periods can be years, though it's common to have one cluster period annually, around the same time of year. 

Screenshot from gammacore.us.

Screenshot from gammacore.us.

While the cluster headaches are relatively rare (affecting 1 out of every 1,000-2,000 people) and their cause not well understood, a new device promises pain relief for sufferers. gammaCore is a small, handheld device that stimulates the vagus nerve in order to block nerve activity that makes these headaches so painful. gammaCore claims relief for patients within 15 minutes of using the device, and it can be used up to 8 times a day. There are no drugs involved and any potential side effects are minimal, mild, and quick to dissipate. 

While the precise cause of cluster headaches isn't known, gammaCore explains that the "vagus nerve—the longest nerve of the head—has been called the “great wandering protector.” It extends throughout much of your body and serves as a control center to regulate many body systems. The vagus nerve plays a role in regulating pain, inflammation, and mood." By tapping into this important pain control center, gammaCore has found some relief for cluster headaches until a cure can be found. 

While patients wait for prevention and a cure, this treatment sure seems like a good placeholder to me. 

Check out this success story and see more on their YouTube channel: