MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Heart attack patients get
‘Guardian Angel’ with new
implantable device
By OMAR FORD
Medical Device Daily Staff Writer
In the U.S., nearly 35% of the females who are heart
attack survivors will go into cardiac arrest a second time
within the same year. Males have a 20% chance of this
occurring. But one company is hoping to reduce these statistics
by developing an implantable device that can monitor
and alert the patient when he or she is on the onset of a
heart attack.
Angel Medical Systems (Shrewsbury, New Jersey)
has developed the AngelMed Guardian – which is currently
going through a pivotal study now called ALERTS. The
device will be implanted in 1,000 patients throughout 50
sites.
“[Guardian] is implanted like a pacemaker in the
patient,” Jonathan Harwood Angel Medical Systems COO
told Medical Device Daily. “It is in the patient and it gives a
real time stress test of the patient’s heart.”
The cardiac monitor and alert system is comprised of
an internal implantable device about the size of a standard
pacemaker with a lead into the heart, a pager device, and a
programmer that aids physicians in evaluating heart signals.
The device is implanted under the skin near the collarbone
and using a wire placed in the right chamber of the
heart. Patients wear the pager at all times and are alerted by
a combination of vibration, beeps, and a flashing light to
notify them to see their doctor or go immediately to the ER.
Typically when patients have heart attacks it is the
result of a blood clot closing one of the three major coronary
arteries. When this occurs there is a shift in the ST segment
of the heart signal caused by the electrical difference
between the portion of the heart muscle fed by the closed
artery and the rest of the heart that is still receiving oxygen.
The Guardian IMD is designed to recognize a potential
heart attack by detecting a shift in the ST segment level of
a patient’s electrogram sensed using a standard pacemaker
lead. The ST segment level is continually compared to
the normal patient electrogram using a patented Angel
Medical Systems detection algorithm.
According to the company, if there are three abnormal
electrical signals that are detected in a row within less than
two minutes time, the patients will get a warning.
“It compares the signals to a baseline that is taken over
a 24 hour period,” Hardwood said. “If there is any change
then it lets off a signal.”
Most recently the company reported implanting two
patients at Memorial Care Heart and Vascular Institute at
Long Beach Memorial Medical Center (LBMMC; Long
Beach, California) with Guardian. The center is one of 16 U.S.
11
hospitals currently participating in the pilot study for the
AngelMed Guardian device.
“A second heart attack within the first year of survival
is very common and unfortunately, most patients don’t go
to the emergency room until three hours after symptoms
start,” said John Messenger, MD at LBMMC in a statement
“Alerting patients that they need immediate medical attention
before it’s too late could profoundly change heart
attack survival rates.”
Harwood is hopeful of the device and says that it has
gotten pretty positive response.
“There are success stories, and this is a huge market
the device is entering,” he said.
Harwood pointed out that the market could grow to
include people who are simply at risk for heart attacks,
such as diabetics and smokers.
The Guardian will probably be launched in about two to
three years in the U.S. for commercial use, depending on
FDA approval. It already has approval in Brazil and there are
plans to gain CE mark approval for the system in the near
future.
(This story originally appeared in the Sept. 21, 2009, edition
of Medical Device Daily)
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