By Judy O’Gorman Alvarez |
Cardiac patients living with Acute Coronary Syndrome (ACS) might feel they have a guardian angel looking out for them, thanks to a new medical device invented right here in the Two River area.
After a long journey of starts and stops, research and trials, in April the U.S. Food and Drug Administration (FDA) approved the AngelMed Guardian®System, the world’s first implantable cardiac monitor and patient alerting system for ACS.
The AngelMed Guardian®System, nicknamed “the Guardian,” is designed to identify changes in the heart’s electrical signals indicative of a potential ACS, including heart attacks or episodes of unstable angina.
“I’m a little numb,” said David R. Fischell, Ph.D., of Fair Haven, co-founder and CEO of Angel Medical Systems, and one of the inventors the device. “It’s been 17 years.”
The Guardian got its start in 2002 in Fischell’s home office, where he and a handful of former AT&T Bell Lab engineers toiled for years to develop the device.
Fischell, who’s company bio describes him as a “serial entrepreneur,” has founded nine biomedical device companies in the last 15 years, including Angel Medical Systems. For 11 years he worked at AT&T Bell Labs in Monmouth County locations. Much of the R&D for the Guardian was performed by former Bell Lab employees.
Fischell’s father, Rober t, ScD., a physicist, inventor and holder of more than 200 medical patents, serves as chairman of the board of Angel Medical Systems. He is credited with developing modern medical stents, lifetime pacemaker batteries and implantable insulin pumps.
The senior Fischell first got the idea for the Guardian when he observed that portable external devices that measure a heart’s activity continuously for 24 to 48 hours, similar to Holter monitors, use electrodes that attach to the skin. “But you can’t wear that 24 hours a day,” Fischell said. “With a heart attack you need to know when it happens. That’s what got us going.”
Fischell and his father, as well as his brother Tim, M.D., an inter ventional cardiologist, set about working on an internal device.
A heart attack occurs when there is a sudden complete blockage of an artery that supplies blood to an area of the heart.
According to Fischell, “14 million Americans have ACS.”
When the Guardian’s implanted monitor detects a potential heart attack, it vibrates, alerting the patient. In addition, a pager-size device beeps and flashes, letting the user know to seek help or call 911.
At the hospital, a physician can retrieve the information collected by the Guardian on a computer.
Despite the current excitement, it was a long road from conception to approval.
After clinical trials at 100 medical centers throughout the country, including four in New Jersey, Angel Medical Systems had to complete an extensive review process for the FDA approval.
The company had to make tough decisions, including reducing its over-head by shuttering its space and allowing its 10 employees to work out of their homes, in order to save money.
Funding through New Jersey’s Technology Business Tax Certificate Transfer Program, also known as the Net Operating Loss (NOL) Program, helped immensely.
Now Fischell and AngelMed are poised and ready to bring the life-saving device to market, planned for sometime in 2019.
“We believe it can reduce the number of patients coming in to emergency rooms every year thinking they’re having a heart attack,” said Fischell, “but are not.”
“We hope the Guardian as it’s released throughout the country will have the potential to save hearts and lives.”
This article first appeared in the July 5 – 12, 2018 print edition of The Two River Times.
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