Monmouth County company gets FDA approval on life saving heart device
Angel Medical Systems Inc., a company based in Monmouth County, has received FDA pre-market approval for a life saving device called 'The Guardian' which will keep an eye on your heart.
It's an implantable cardiac monitor that alerts patients who've had ACS events to any potential life threatening activity.
"Today, at least half of heart attacks either have no symptoms or symptoms that patients don't recognize," Dr. David Fischell, AMS CEO said. "It creates a model over time of what's normal for you and is comparing that normal machine learned basis to what's going on now."
The device isn't meant to improve the function of your heart but help protect you.
"This is there to keep that heart that's still functioning for you as functional as possible into your future and to some extent save you from an earlier death from a heart attack," Fischell said.
The Guardian is set to monitor your heart 24/7/365.
"It's designed to be implanted in the left side of your chest, very similar to a pacemaker and connects to your heart with a wire," Dave Keenan, AMS COO, said. "It analyzes your cardiac signal all the time looking for the change that is the signature of an inclusive event, meaning that a coronary artery is getting blocked which is what causes a heart attack."
It'll vibrate an alert when it senses an issue and sound off an alarm.
Based on how severe will determine whether you need to make an appointment with your cardiologist or go to the ER.
It has two alarms, one to detect emergencies and one for less urgent events.
"Our device is designed to monitor the heart rates as well as rhythm," Keenan said. "The emergency alarm is for a heart attack/ACS event but the second alarm/see-doctor alarm."
When patients get the see-doctor alarm, they should do just that.
"They're instructed to call their cardiologist and make an appointment and go in and see them within the next seven to ten days because there's something being detected which because of your high risk it should be evaluated," Keenan said.
'The Guardian' is for someone who's had an ACS event like a heart attack, but there are some exceptions to qualify to have this device implanted.
"If you have co-morbidities, meaning you also are diabetic, you have kidney problems or you smoke and your overweight, that also increases your risk for having a recurrent event and that makes you a candidate," Keenan said.
He adds that the device itself has to be prescribed to you by your cardiologist if they find you meet the categories.
The device is implanted the same way a pacemaker is and has no expiration date but the battery must be replaced every seven-years.