Circulatory System

Med Device Monday: Aethlon's Hemopurifier

Today is our fourth and final post in our October series, and today we’re talking about another Breakthrough Device  that has yet to hit the U.S. market. And since it’s almost Halloween, what a perfect time to talk about Dracula’s favorite topic: blood! The Aethlon Hemopurifier® is a first-in-class device developed for rapid elimination of circulating viruses and cancer-promoting-exosomes from the body. In simpler terms, the device acts like a filter by straining out impurities— in this case, viruses and cancer cells— from the blood. The device has been awarded the breakthrough status because it fulfills one of the conditions for the breakthrough designation; namely, its ability to provide a more effective treatment for a life-threatening or irreversibly debilitating human diseases.

The hemopurifier is a one-time use, disposable cartridge that can be attached to dialysis and other blood circulatory equipment commonly used in health care settings. The entire circulatory system of a patient can pass through the cartridge about one time every 20 minutes. The cartridge consists of a biocompatible plasma membrane (with 200 nm diameter pores) coated with a plant-derived lectin known as Galanthus nivalis agglutinin (GNA). GNA binds to polymeric structures called glycans found on the surface of the viruses and exosomes, capturing them, and keeping them from re-entering the patient’s circulatory system. Viruses and exosomes are known to use this “glycan shield” in order to camouflage and subvert the body’s immune system. GNA selectively binds to a broad spectrum of infectious viruses while having limited interactions with most human proteins. You can really put this into perspective and understand how incredible this is when you evaluate the other anti-viral drug regimens that are used today, and the prolonged amount of time patients must participate in those regimens. Studies have shown that GNA is capable of inhibiting many viral pathogens such as Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Dengue Virus, Ebola Virus and Severe Acute Respiratory Syndrome Coronavirus.

Image from www.aethlonmedical.com

Image from www.aethlonmedical.com

Recently, we have seen the emergence of new viruses and the reemergence of old viruses that cause severe and fatal infections. The increase of these viruses is often induced by international travel, global warming, and densely populated urban environments. The majority of these viruses have no vaccines or treatments available, and depend solely on the body’s immune system to fight off the infection. Ebola, Zika, and Chikungunya are examples of such viruses capable of causing lethal infections for which no approved treatments exist. The outbreak of Ebola and Zika infections in the recent past are reminders of the need to develop therapies to prevent future epidemics.

Aethlon hemopurifier therapy has been successful in curing patients infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In 2014, the device was successful in treating a comatose Ebola-infected physician. In fact, a single administration of the hemopurifier therapy was successful in saving the patient with multiple organ failure. This led to Time Magazine naming the Hemopurifier as one of the "Top 25 Inventions," as well as one of the "Eleven Most Remarkable Advances in Healthcare." The company is currently conducting pre-clinical studies on mosquito-borne viruses like Chikungunya, Dengue, and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human Smallpox infection.

Hemopurifier therapy is also being applied to the capture of exosomes. Exosomes are vesicles that are released by cells into the circulatory system where they are distributed throughout the body. They have been implicated in intercellular communication and the transmission of certain diseases within the body. Compared to normal cells, tumor-derived exosomes (TEX) are released by cancer cells in exponentially greater numbers. TEX is associated with cancer progression, immune suppression and chronic inflammation. In fact, 90% of all cancer-related deaths are attributed to metastasis involving exosomes. Moreover, studies have shown that TEX is resistant to a wide range of anti-cancer drugs. In addition to their role in cancer metastasis, exosomes have also been implicated in the progression of Alzheimer and Parkinson’s, as well as numerous inflammatory diseases. Thus, therapeutic approaches targeting the exosomes, such as the hemopurifier therapy, address a significant unmet need in the medical field.

It is devices like the Hemopurifier that FDA aims to safely get on the U.S. market. Breakthrough Devices often offer solutions for diseases where no cleared or approved treatments exist, or they provide significant advantages over already-existing therapeutic approaches. Clean blood is something both patients and Dracula can smile about!

Have a safe, effective, and happy Halloween, everyone!


Additional Reading

  1. Aethlon Medical Website

  2. Press release for Athleton Breakthrough Status

  3. Breakthrough Devices Program

  4. Info about Dracula

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: Implantable Continuous Pump for Remodulin

Imagine you have a condition where your body doesn't produce enough of the chemical that keeps your blood vessels open and clear, instead allowing them to thicken. This of course impacts the amount and flow of oxygen you're getting and thus affects your heart and lungs. Imagine that there is, fortunately, a treatment for this. But treatment requires regular visits to medical professionals for IV drips or shots, to keep your body functioning and battling this condition. You go because these visits are helping keep you alive. But what if you could just have the whole system implanted and skip most of those visits, constant monitoring, frequent skin punctures, and some of the possible side effects? Well, now you can. 

Pulmonary arterial hypertension (PAH) is a progressive disease where they body doesn't make enough prostacyclin, which allows the pulmonary system to function properly. Remodulin (treprostinil) is a drug that can treat this condition, but which needs to be regularly administered. A new system recently approved by FDA allows the whole thing to be implanted and doses administered automatically via an IV catheter, thus improving quality of life: the Implantable System for Remodulin is a fully implantable system designed to deliver Remodulin® (treprostinil) injection intravenously for the treatment of patients with pulmonary arterial hypertension (PAH). 

Remodulin is stored in the pump reservoir and, per a programmed prescription, moves through the pump tubing, the catheter port, and the catheter to the intravascular delivery site. The programmer is a handheld device that is used to review and program pump parameters using telemetry, a radio frequency (RF) communication. The physician or healthcare provider usually calibrates this at a first visit. Subsequent visits are of course required, but the level of maintenance versus routine IV drips or injections is considerably less.

Image from medgadget.com.

Image from medgadget.com.

The American College of Cardiology sums it up well: "The most notable benefit of the implantable system is that it significantly reduces the rate of BSIs [blood stream infections] and site infections versus that associated with external IV systems. It also eliminates chronic treprostinil-induced infusion site pain associated with SC administration. By reducing the rate of catheter-related complications and pump user errors that cause drug interruptions or overdose, it improves the consistency of therapy. Finally, it improves patient's quality of life by eliminating the daily burden of system management, and reducing restrictions and fear during normal activities of daily life. The majority (93%) of patients rate the implantable system as "very good" or "excellent"."

The Implantable System for Remodulin, which is marketed by Medtronic, is made up of 3 parts:

·      The pump (Medtronic SynchroMed II 8637P Programmable Pump)

·      The catheter (Medtronic 8201 Implantable Intravascular Catheter)

·      The programmer (Medtronic N’Vision 8840 Clinician Programmer with 8870 Application Card)

The pump is implanted by the surgeon in the subcutaneous pocket using an incision in the lower abdomen. The intravascular catheter is connected to the pump and inserted through a vein at the superior caval-atrial junction which is the junction between the superior vena cava and the right atrium of heart. The pump reservoir remains permanently implanted and the health care provider uses a needle and syringe refill kit to refill the pump with Remodulin by a percutaneous procedure. 

Image from medgadget.com.

Image from medgadget.com.

This medical device does come with some parameters. Restrictions for The Implantable System for Remodulin should not be used in the following patients, including NYHA Class IV heart failure patients; patients who cannot tolerate a sudden cessation of Remodulin therapy; patients with a known or suspected infection, bacteremia, or sepsis requiring antibiotics; patients with vasculature that is inadequate for an 8 French introducer or catheter advancement without stylet guidance; patients implanted with leads or catheters (active or abandoned) in the superior vena cava that cannot be removed prior to or at system implant; patients whose body size is not sufficient to accept pump bulk and weight; patients with skin or soft tissue that would heal poorly, increase susceptibility to infections, or is unacceptable for implant of this system; patients for which a health care provider cannot implant the pump 2.5 cm or less from the surface of the skin.

It's interesting and exciting to see how medical devices can make for new versions of existing successful therapies. This implantable system is a great example of how quality of life can be improved via medical device technology without having to reinvent the proverbial wheel.

 

Further reading:

Remodulin Implantable FDA Approval

Remodulin Implantable FDA Approval Letter

Remodulin website

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: Easier Umbilical Venous Catheterization

A month or so ago, we talked about the first MRI device created specifically for neonates. This week, we're talking about a special catheterization device to make certain IV procedures on neonates safer and easier. As a reminder, August on this here blog is dedicated to discussing up and coming medical devices that have not yet gained FDA approval. 

The umbilical vein is unobstructed and available in newborns for about the first week of their life. It is generally the easiest way to start a catheter/IV in a very young baby, especially in an emergency, and many lifesaving neonatal procedures rely on this vein for access. Per Navitechnologies, "Roughly 30% of patients admitted to Neonatal Intensive Care Units (NICUs) require a potentially life-saving procedure called an Umbilical Venous Catheterisation (UVC). UVC procedures provide a vital pathway to deliver nutrients and drugs to critically-ill babies."

Unfortunately, the vein can be difficult to locate, and mistakes can be harmful - or even fatal. 

In fact, Navitechnologies says, "Current techniques are inadequate where 40% of attempts result in misplaced catheters due to lack of real-time feedback."

If you guessed that Navitechnologies is talking about this because they have a medical device for it, you would be correct!

Photo from navitechnologies.com. 

Photo from navitechnologies.com. 

Navitechnologies' device, NeoNAV, is designed to make placement of a UVC accurate and safe the first time. Using technology, it provides realtime feedback as to the placement of the end of the catheter, guiding the clinician and ensuring the catheter is following the vein. It's not a new catheter system, but rather an add-on for existing ones. 

Since this is a fairly new device that has not yet been approved, there are no videos or pictures of the interface, but I love the idea of technology improving an existing medical device to make it easier, safer, and more effective. Their website says that a "traffic-light system" guides the clinician thanks to their proprietary algorithm. Proprietary algorithms for the win!

Screen cap from navitechnologies.com. 

Screen cap from navitechnologies.com. 

Neonatal care has certainly come a long way. It wasn't terribly long ago that premature babies and certain, now-survivable medical conditions meant death for a newborn (and often, its mother). While we have of course made awesome progress, it is so exciting to me to see these new devices that are specifically designed for the specialized care of newborns. I can't wait to see what comes out next!

 

Further reading:

FDA's page for pediatric devices

Incubator product classification (throwing it old school, because it's still essential!)

First neonatal MRI device