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Heart and Vascular

Riverside Announces FDA Approval of Worlds First and Only Implantable Cardiac Monitor and Patient Alerting Capability

August 08, 2018

Riverside Health System announced this week that the AngelMed Guardian® System, following a clinical study in which patients from the Riverside Regional Medical Center in Newport News, Va. participated, has received U.S. Food and Drug Administration (FDA) premarket approval (PMA).

The AngelMed Guardian System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. It is indicated for use in patients who have had prior Acute Coronary Syndrome (ACS) events, including myocardial infarctions (heart attacks) or unstable angina and who remain at high risk for recurrent ACS events. The Guardian System is an adjunct to patient recognized symptoms by detecting potential ongoing ACS events, characterized by sustained ST segment changes, and alerting the patient to seek medical attention for those events.

Approval of the AngelMed Guardian System by the U.S. FDA was based on preclinical and clinical data, including data derived from the ALERTS Clinical Study that began in 2009. Riverside Regional Medical Center was among the 100 centers across the U.S. that participated in the ALERTS Clinical Study, with 910 patients implanted. The ALERTS Clinical Study concluded in 2016 after accumulating 3,450 implant years of follow-up data.

“We are so thankful to Riverside Health System and their Riverside Regional Medical Center for all of their efforts during the ALERTS Clinical Study,” said Angel Medical System’s Chief Executive Officer, Dr. David R. Fischell. “Without their dedication and hard work, we would never have reached approval. We will also be forever thankful to the patients who participated in our clinical study. We have worked tirelessly to bring this device to market to fill this unmet need that addresses a life-threatening condition and may improve their quality of life."

The national principal investigator for the ALERTS pivotal clinical study, Dr. C. Michael Gibson of Harvard Medical School, said “patients who have had a recent acute coronary syndrome often remain at a high risk of a recurrent event. The AngelMed Guardian System has shown it can identify true heart problems better than patients' symptoms alone as well as in those patients who have no symptoms."  

"Helping our patients was always foremost in our minds and hearts," said Angel Medical System’s Chief Operating Officer David Keenan.

The Guardian System is implanted like a pacemaker, typically in less than an hour under a local anesthetic. This well-studied implantation technique demonstrated an adverse event rate that was also very similar to the rate seen for pacemaker implants. The types of adverse events seen were also similar to those seen with pacemaker implants.

With a history of heart disease and Type II diabetes, Clarence Pasley underwent a four-way bypass surgery at age 50. Now 67, and still working full time, Pasley was approached by cardiologists at Riverside Regional Medical Center and invited to participate in the ALERTS research study. He agreed, and the device was implanted in March 2011 and remained activated for five years before the study ended.

Pasley credits the device with predicting and possibly preventing a major heart attack. 

“I wasn’t having any symptoms at all,” he said. “But when the alert went off, I went immediately to the Emergency Room. I was seen right away, and when the EKG and enzyme test didn’t show anything, they told me to go to my cardiologist.”

In his doctor’s office two days later, Pasley remembers the alert went off again during a stress test. His cardiologist admitted him for a catheterization, and a blockage was found on the back-side of his heart. He remained in the hospital for two days.

“I tell you right now, it worked for me,” Pasley said of the alert device. “I wasn’t having any symptoms, so I would never have known that blockage was there if the alert hadn’t gone off and I hadn’t gone for that stress test.  It might have been a heart attack sitting there waiting for me.  It did just what it was supposed to do.”

Today, Pasley is waiting to learn if Medicare will cover the cost of reimplantation.  

Bill Weaver, a Gloucester, Virginia native and 78-year old retired college professor, who taught agricultural, poultry and animal science at both Virginia Tech and Penn State University, had a triple bypass at Riverside Regional Medical Center in 2003. Years later, although he wasn’t experiencing symptoms, a routine treadmill test indicated a blockage, and after a heart catheterization was peRiverside Foundationormed, a stent was put in. 

“I’d been involved in research all my life,” Weaver said, “so it was an easy decision” to participate in the ALERTS study. The device was implanted on September 9, 2010.

During the six years that the device remained implanted, Weaver recalls receiving several alerts, two of which were the more serious type, requiring an immediate trip to the Emergency Department. While noting these may have occurred while he was exerting himself with yard work and the like, he was asymptomatic each time. 

Weaver was fortunate: no further blockage or disease was found. 

To a man of science, the experience was a success.

“True, they didn’t find any damage,” Weaver said. “But when they went back and looked at the data from the alerts, in each instance they could tell to the minute what had happened. The device was reading an actual incident. It could have been a heart attack. I was lucky.”

As an academic, Weaver said he’s curious about what advancements have been made since the device was removed in 2016, but said he would very seriously consider it if his cardiologist recommended re-implanting the system – and if Medicare approves it.