Respiratory System

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. 

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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.

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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. 

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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: Bloom Inhaler

This month I'm featuring products that have not yet been FDA approved. I've written before about why I do what I do and why it's important to me to get innovative devices like these to market. Products like this are integral to my work, but moreover, they are interesting, innovative, and fill a need. Join me this month in exploring some exciting new devices that I hope to see on the market soon. Feel free to share more innovative devices in the comments!


Last week we kicked off our month of 'not-yet-approveds' with Allotrope Medical's ureter detector. Today we're talking about something that feels a little more personal to me: Bloom, a credit card sized inhaler. If you're familiar with regular asthma inhalers, you know how bulky and inconvenient they can be. This is especially true if you're not carrying a bag, or are carrying a small one: Bloom literally fits in your wallet. 

Versus a traditional inhaler:

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Imagine being able to easily and unobtrusively carry an inhaler in your back pocket, or in a wallet or evening bag. What's more, it's affordable. According to Bloom's FAQ section, once FDA approves the device, it will be available for $40. 

Bloom is intended to be filled directly from a regular inhaler: you simply pop out the cartridge of your traditional inhaler, and pump it several times into the Bloom inhaler, up to six doses. (If you've ever used a perfume atomizer, you might be familiar with this method.) Astute observers will also note that Bloom's design calls for the open mouth inhale, versus the traditional method of sealing one's lips around a mouthpiece. Per Bloom, "The "Open Mouth Technique" is similar to using a breath spray. Press and inhale through the opening, just as you would with your current inhaler. This technique is clinically proven to be equally effective at delivering precise doses deep into the lungs." 

According to CBS News, the inspiration for Bloom came from creator James Cazzoli's personal experience: "My best friend growing up has severe asthma. It was horrifying to watch him gasp for breath on the way to the ER. My younger brother has asthma as well. I know how dependent asthmatics can feel to their medication. I'm passionate about healthcare and want to create something that truly improves the lives of people with asthma," he said. 

I can relate: I grew up suffering from asthma. I ended up in the hospital a few times as a kid. When I collapsed on the asphalt in first grade while running around playing tag with friends, my parents received a letter saying that I had to have my inhaler on me "at all times!" Later, as an athlete in high school, I always had one of those bulky inhalers jammed into my sock or strung around my neck with some string. Without fail, I seemed to have the worst asthma attacks when I forgot my inhaler, as I'd work myself into a fit of panic knowing I didn't have the security of my medicine. Fortunately, my asthma is under control now and I only need my inhaler two or three times a year—but when I need it, I really need it. Having the Bloom inhaler would have been a game changer for me as a kid (and yes, I've already reserved mine!).

Devices like these, which make carrying life-saving medicine more convenient, perfectly illustrate why I do what I do, and why I want to help more devices like this get to market.