Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat and death if not treated. Thus the LifeVest treats abnormal rhythms by applying a high energy shock similar to that of a traditional defibrillator.
What FDA class do you think this wearable cardioverter belongs in? Why?
What are some of the challenges Zoll Lifecor Corporation might have faced trying to get this device approved?
In class, we learned about how the market plays a big role for projects to go on the production line. Do you think this LifeVest is considered a marketable device that can be profitable for companies? (Hint: You can look into if there are any competitors)
If the inventors of LifeVest were to develop a mobile application that showed the user his or her heart rate only when the vest is worn, would this app be considered a mobile medical application? Why or Why not? (See the previous post about mobile medical application and reference describing mobile medical application for help)
Reference:
LifeVest Wearable Cardioverter Defibrillator: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm458494.htm
Mobile Medical Application:
http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf
http://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm255978.htm
I would classify the Zoll Lifevest as a class 3 device because it has really high risk and it is used to help sustain life. The lifevest device begins to apply high energy shock during life threatening scenarios of ventricular tachycardia or ventricular fibrillation. However, this device will send electric shocks when it detects an abnormal rhythm even if it is not life threatening. This device requires clinical trials to justify its claim and show that the device does less harm to the human body compared to benefits.
Some obstacles that Zoll Lifecor encountered when trying to get FDA approval for the lifevest might have been based on safety. The lifevest has many safety precautions such as an alarm every time the device is about to execute an electric shock. There also is a button the user can click if the alarm goes off and the patient does not require the defibrillator. FDA would have scrutinized the clinical trials to make sure that the device was safe.
People with cardiac issues such as arrhythmia or previously had a cardiac arrest can use this device on an daily basis. This device bridges the market gap between having an implanted device. Many patients need defibrillators and there are invasive procedures to implement them into the human body, but this lifevest allows the patient to have a defibrillator without needing to go through surgery.
References
http://www.startribune.com/wearable-defibrillator-can-bridge-the-gap-to-implanted-device/232122331/
I agree with bb252 that it is definitely a Class III device as it poses high risk to the patients. But this device is generally used under the condition where the patient has a weak heart and implanting ICD is not an option and is likely to benefit from its usage. Apart from that it overcomes some of the limitations of ICD's with respect to magnetic and electromagnetic radiations. So in my opinion, after discussing the potential benefits and risks with the physician associated with this device, it is worth giving a try for the patients who are at high risk for sudden cardiac arrest.
I also agree with bb252 and Shachi in the respect that this LifeVest Wearable Cardioverter Defibrillator is in fact a Class III medical device. In regards to potential challenges faced while trying to get this device approved, I believe that proving its reliability to be able to successfully detect heart arrhythmias along with not misfiring when the device isn’t needed. In both of these circumstances, the direct action of this device would have a very big impact on the patents quality of life. In addition, I think one of their bigger challenges is making sure this device wouldn’t trigger during normal exercise patterns when heart rates naturally elevate. Lastly, the amount of voltage probably has to be calibrated to how much body fat the patient has, because unlike a traditional pacemaker, the voltage has to travel through the skin, fat, and muscle to successfully reach the heart. Determining this scale of voltage used per person would have probably been a pretty sizeable task.
HeartStart FR3 which is a best professional-grade AED is one of the competitor with Zoll life vest. Both have similar features to certain extent but I feel Zoll Life Vest is a better marketable and comfortable device for patients. The method in which the electrodes are set up in it is so good and it gives a relaxed feel for patients who wear it. It's similar to a clothing which can be held towards the body firmly and has a stable attachment. But in case of HeartStart FR3 the electrodes are set up directly. This may make the subject feel restless in giving the feel that it might drop down. I am saying in this in the view of being comfortable. We should make a heart patient comfortable and calm even that plays one of the role in preventing the abnormal rhythm. So Zol Life vest is a profitable one.
For the mobile application, if the only function of the application was to show the heart rate I believe it still would be subject to FDA regulation. It certainly would have an easier time passing FDA hurdles than if there was more functionality to it, such as if this app allowed the user to control the voltage of the electrodes and other important functionalities. Additionally, since the app is tied to this product, it still must undergo mobile medical application regulation.
I would say that the Zoll LifeVest is a Class III device due to the fact that it has a high amount of risk. If the device fails there is the possibility of sudden cardiac death. I would think that the most difficult past of getting approval would be the vest incorrectly measuring heart rate and giving a shock or vest malfunction and not being able to give the shock a patient needs. It seems as though there are enough safety precautions and back ups on the vest to prevent an unwanted treatment, such as the alarm and button to shut it off.
Being that this post started about a year ago I found that patients have started using this device. The FDA game Premarket Approval and works with Zoll to address the concerns of possible failure. There was one death due to failure of the vest in November of 2017, however it was after the device displayed a service code which they tell users to contact Zoll immediately for service and a replacement if needed.
I do believe that this is a marketable device as long as the amount of people that are not candidates for/refuse the implantable cardioverter-defibrillators is substantial. Someone mentioned the HeartStart FR3 as a competitor to the Zoll LifeVest. While they do achieve the same goal I think are different because the LifeVest is automatic, after it senses the problem the alarm goes off and it delivers the treatment. The HeartStart FR3 is more of a portable defibrillator. It needs to be placed and set off to deliver the shock. This device can be used by anyone but is suggested to be put in ambulances and used by professionals when the LifeVest is to be worn and used anytime and anywhere.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S056
http://www.heart.org/idc/groups/heart-public/@wcm/@hcm/documents/downloadable/ucm_300340.pdf
I would say that the Zoll LifeVest is a Class III device due to the fact that it has a high amount of risk. If the device fails there is the possibility of sudden cardiac death. I would think that the most difficult part of getting approval would be the vest incorrectly measuring heart rate and giving a shock or vest malfunction and not being able to give the shock a patient needs. It seems as though there are enough safety precautions and backups on the vest to prevent an unwanted treatment, such as the alarm and button to shut it off.
Being that this post started about a year ago I found that patients have started using this device. The FDA game Premarket Approval and works with Zoll to address the concerns of possible failure. There was one death due to failure of the vest in November of 2017, however it was after the device displayed a service code which they tell users to contact Zoll immediately for service and a replacement if needed.
I do believe that this is a marketable device as long as the amount of people that are not candidates for/refuse the implantable cardioverter-defibrillators is substantial. Someone mentioned the HeartStart FR3 as a competitor to the Zoll LifeVest. While they do achieve the same goal I think are different because the LifeVest is automatic, after it senses the problem the alarm goes off and it delivers the treatment. The HeartStart FR3 is more of a portable defibrillator. It needs to be placed and set off to deliver the shock. This device can be used by anyone but is suggested to be put in ambulances and used by professionals when the LifeVest is to be worn and used anytime and anywhere.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010030S056
http://www.heart.org/idc/groups/heart-public/@wcm/@hcm/documents/downloadable/ucm_300340.pdf
Zoll LifeVest is a Class III , FDA requires PMA submission, for example implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.
This device also is used to help sustain life, which means high risk, so definitely will be Class III.
And, also, according to FDA definition for mobile medical apps:
Any Mobile apps that allow a user to collect (electronically or manually entered) blood pressure data and share this data through e-mail, track and trend it, or upload it to a personal or electronic health record.
or the app be used as an accessory to a regulated medical device; or To transform a mobile platform into a regulated medical device, will be considered as a mobile medical app.
The Lifevest would have to be a Class III because it has the potential to save a life, though is a great risk to the wearer. Because the response of the mechanism is based off the persons heartrate, there is concern for what conditions would warrant a defibrillator, so I would recommend talking to the physician to make sure an ICD wouldn’t be better.
Undoubtly this device went through some intense clinical trials to verify the safety. Not only does it have to be successfully able to detect a heart rate, abnormal at that, but also respond with the correct voltage and pressure in the proper locations. There’s also the concern of environment, i.e. to make sure the device doesn’t short circuit or decalibrate (?) is someone say spills water on themselves.
The mobile app is an interesting idea, but I think it would be better if the device was able to call for help like AARP or a hospital when triggered.
