Personalized Medicine

Med Device Monday: Guided CPR Device

Most of us have probably been through a cardiopulmonary resuscitation (CPR!) training course, or at least have a passing familiarity with what CPR entails. Chest compressions, mouth-to-mouth, keeping up certain counts and rhythms: if you haven't been trained or had to do it yourself, then it's likely you at least know about it from movies and TV. Indeed, a quick YouTube search shows up dozens of clips and montages of CPR being done on screens big and small. Although, maybe be wary if you're trying to learn CPR at a paper company in Scranton, PA:

Performing CPR on someone, particularly if you're not a professional, can be a scary proposition. Especially if it's the first time you've had to do it, your training wasn't recent or hasn't been practiced very much, and/or it's someone you love. It's easy for all that training to go out the window in a moment of crisis. Imagine how it would be made easier if there were a device guiding you? Well now there is...although it's only for professionals. It's still pretty exciting!

When a person experiences sudden cardiac arrest, defibrillation and CPR are the two of the most critical components of the first line of treatment. Zoll® is marketing a new line of professional defibrillators—X Series®, R Series®, AED Pro®, and AED 3 BLS®—to help make delivering this time-dependent treatment as quickly and effectively as possible. In addition to delivering lifesaving electrical shocks, this line of defibrillators also provide realtime CPR help, giving the person administering CPR live feedback on the depth and rate of chest compressions—thus allowing any changes to be made to help provide the most effective treatment. While these devices are only to be used by medical professionals, it's not hard for the rest of us to imagine how very useful they could be. 

Photo from fda.gov.

Photo from fda.gov.

These devices from ZOLL have the ability to monitor: electrical activity of the heart via electrocardiogram (ECG) and 12-lead ECG analysis; effectiveness of the CPR; temporary cardiac pacing (external transcutaneous pacing); blood pressure, without puncturing the skin (non-invasive blood pressure monitoring); amount of oxygen in the blood (SpO2); number of breaths a patient takes per minute (respiration monitoring); carbon dioxide (CO2) levels; blood pressure.

So, how does it work? Per FDA, "The ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® devices use two multifunction defibrillation electrodes to acquire a patient's electrocardiogram (ECG). If this device detects an abnormal heartbeat, it may advise the user that a high-energy shock is necessary. The user interface will provide voice instructions to guide the user through the rescue process including cardiopulmonary resuscitation (CPR). The device will provide an audible rhythmic beeping sound to help the user deliver the correct rate of compressions while giving CPR. If a defibrillation shock is required, the device will prompt the user to deliver an electrical shock, through the electrodes."

When the unit detects a shockable rhythm, it charges and issues the warning "PRESS FLASHING SHOCK BUTTON". The rescuer presses the Shock Button to deliver the shock. The rescuer will then be prompted to perform CPR for a period of 2 minutes, after which the unit automatically initiates a new ECG analysis.

As previously stated, the ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® devices should be used only by trained medical personnel to treat both adult and pediatric patients with sudden cardiac arrest or who are unconscious, not breathing, and without a pulse. While most of us 'medical civilians' will still have to rely on our CPR classes and proper training to deliver CPR in an emergency, this is pretty impressive stuff. We've said it here before, but sometimes technology is most interesting when it makes an existing staple of healthcare even better. 

 

Further Reading:

FDA announcement of recent approval

ZOLL Premarket Approval (PMA)

Zoll FDA approval letter

 

 

 

Med Device Monday: Surgical Sealant

Just consider how the old nursery rhyme would have ended if all the King's Horses and all the King's Men had access to surgical glue. That's what we're talking about this week in Medical Device Monday! PREVELEAK® Surgical sealant is used in vascular reconstructions and open heart surgery to mechanically seal areas of leakage. The device consists of a liquid made of two components: purified bovine serum albumim (BSA) and polyaldehyde. The two components are contained in separate barrels of a syringe. During surgery, the two components mix together when a health care provider pushes the plunger of the PREVELEAK® syringe. When these components are mixed, a flexible material is formed. The resulting mixture is applied to seal holes and stop bleeding.

 

Photo from fda.gov.

Photo from fda.gov.

PREVELEAK® Surgical sealant is commercially marketed by Mallinckrodt Pharmaceuticals. According to the company, PREVELEAK® Surgical sealant, which uses the purified bovine serum albumin, is biocompatible. It gels in 10 to 15 seconds, achieving a strong seal in 60 seconds. It has a burst strength in excess of 500 mm Hg and remains flexible after application. It also has elasticity similar to that of a healthy human aorta, which helps in the natural movement of vessels. In a clinical study, immediate sealing was achieved in > 95% surgical procedures using PREVELEAK®.

Mallinckrodt Pharmaceuticals claims that some of the key safety features of PREVELEAK® Surgical sealant are that it is

1.     Minimally inflammatory: The Polyaldehyde cross-linker minimizes the inflammatory response associated with glutaraldehyde-based sealants.

2.     Minimal swelling: It reduces the potential impact on surrounding anatomic structures that may be sensitive to compression.

3.     Noncytotoxic and bioresorbable.

According to Mallinckrodt Pharmaceuticals, PREVELEAK® Surgical sealant is ideal for a broad range of surfaces and sealing challenges, such dry surfaces and surfaces devoid of free-flowing blood, native vessels as well as synthetic vascular grafts, and vertical surfaces. It can also be used in anticoagulated patients. 

A wound sealant that literally is made to fit the mold is fantastic, and the implications for a product like this aren't difficult to imagine. And it probably would have been a pretty life-saving device for poor Humpty Dumpty as well!

preveleak_applied_graft.jpg
Photos from hemostatsolutions.com.

Photos from hemostatsolutions.com.

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: A Medical Device for Substance Use Disorders

When we think of treating substance abuse, it's typically drugs, therapies, and various rehabilitations that come to mind. But last week, FDA announced that it has approved marketing of the first medical app (yes, like the kind from the App Store) to help treat Substance Use Disorders (SUD). The device is intended to be used together with outpatient therapy, and it's not intended for use with opioid addiction or for those who are dependent only on alcohol. But still, medical treatment through a mobile app? It's hardly the first time we've said it here, but the future truly is now!

Substance Use Disorder is, in a word, addiction. The Substance Abuse and Mental Health Services Administration shows a group of disorders that fall under this title, including dependence on alcohol, cannabis, tobacco, stimulants, and hallucinogens. Note that they also make clear distinctions about the words they choose to describe these disorders, saying, "The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), no longer uses the terms substance abuse and substance dependence, rather it refers to substance use disorders, which are defined as mild, moderate, or severe to indicate the level of severity, which is determined by the number of diagnostic criteria met by an individual." They go on to say, "Substance use disorders occur when the recurrent use of alcohol and/or drugs causes clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home. According to the DSM-5, a diagnosis of substance use disorder is based on evidence of impaired control, social impairment, risky use, and pharmacological criteria.".

Of course, most of us will unfortuantely have at least a passing familiarity with what substance dependence means and looks like. All the more reason that an accessible mobile medical device for treatment is fantastic news. 

reSET Pear Therapies addiction app
Screencaps from peartherapeutics.com

Screencaps from peartherapeutics.com

reSET, from Pear Therapeutics, is the name of this app, which is used on a patient's phone or tablet and monitored by their clinician via a desktop interface. It's designed to encourage and maintain abstinence from the substance the patient is dependent on. It delivers to the patient cognitive behavioral therapy (CBT) and acts as part of a larger overall plan of treatment. In fact, in clinical trials, treatment via reSET saw better outcomes than those patients who used only traditional, in-person therapy. CBT is a system of talk therapy designed to make the patient aware of negative or destructive patterns of thought and change their behavior around them. 

While this medical device is, like any medical device, not a magic bullet, it is really encouraging and exciting to see how technology can serve patients and the medical device community. This is a really promising development and I look forward to following this company and this device in the future. Check out the other devices they have on deck which have not yet been approved, by clicking here.

 

Further reading:

FDA's de novo approval

Pear Therapeutics press release

FDA press release: FDA permits marketing of mobile medical application for substance use disorder

Med Device Monday: Watching Patient Time

Wearable devices are all the rage these days, from Fitbits to GoPros, to—yes!—medical devices. We've talked about some medical device wearables here before, here and here and even earlier this month.

The company we're featuring today is part of this month's theme of not-yet-approved-byFDA medical devices. It's a bracelet patients wear to track time. It sounds simple enough, but the uses and possibilities for it are endless. 

Screen Shot 2017-08-28 at 8.50.15 PM.png
Photo from docktechnologies.com.

Photo from docktechnologies.com.

The bracelet is activated when it snaps onto a patient's wrist. Data can be viewed on the wristband and on a desktop app that allows for tracking, data monitoring, and various insights. Speaking of insights, why track time intervals? So many reasons. 

The time on the flexible, disposable wristband can be viewed under normal light conditions from at least 20 feet away. Current data is available on the wristband at a glance, and historical data is visible on the dashboard. With a click of the button, the data point (time period) is saved to be viewed later on the dashboard, so there's no doubting how long a patient has been waiting for a CT scan, a check, or a dose. 

This is the kind of technology that can transform the day-to-day activity of medicine. While I suspect that using a device like this would take a little bit of a learning curve, as any new habit does, it could also be a powerful tool in the tool belt of medical professionals across the country. While I've given a few examples here, I truly believe the possibilities for a device like this could be endless. 

How would you use a device like this?

 

Further reading:

Info from FDA on digital medical technology

21st Century Cures Act