GRAND RAPIDS — Spectrum Health wants to become one of the first cardiac care providers in the nation to use an innovative diagnostic device that monitors and warns cardiac patients of an impending heart attack.
The AngelMed Guardian System — co-developed by Kalamazoo cardiologist and innovator Dr. Tim Fischell; his father, Robert Fischell; and brother, David Fischell — comes to market late this year. The diagnostic device offers a “disruptive technology” that alerts patients to seek medical treatment, said Dr. David Wohns, cardiology division chief at Spectrum Health.
Using AngelMed would give Spectrum Health “another tool to our arsenal in our continued efforts to provide the best care for our patients,” Wohns said.
“It’s an early-warning system. We don’t have that now,” he said. “It has enormous potential for reducing the long-term consequences of heart attacks for patients.”
Eatontown, N.J.-based Angel Medical Systems Inc., a company the Fischells co-founded in 2001 and where David Fischell serves as CEO, produces the device, which is implanted in patients similar to a pacemaker. When it detects heart activity that signals of acute coronary syndrome (ACS), or blockages of blood in the arteries, it alerts patients to seek medical attention.
The diagnostic device can even alert patients when they are experiencing what’s known as a “silent” heart attack that lacks symptoms.
Spectrum Health participated in a clinical trial that led to Angel Medical Systems earning U.S. Food and Drug Administration approval for the diagnostic device in April 2018. In April of this year, the company closed on a $10 million Series A financing round to bring the device to market in the fourth quarter of 2019.
The funding “represents a new day to survivors of ACS events (including heart attacks) and the health systems that care for them,” David Fischell said in a June news release announcing the capital investment.
In June, Angel Medical Systems also signed a long-term distribution agreement for the Asia Pacific market with existing major investor Jasper Capital Ltd. of Singapore.
The AngelMed device is initially intended for patients who previously suffered a heart attack and are at high risk for another. In a clinical trial from 2009 to 2015 involving 37 patients at Spectrum Health where Dr. Wohns served as principal investigator, “patients felt safer knowing they were being monitored like this with a warning system.”
“Often cardiac events are unpredictable,” Wohns said. “They uniformly loved having a sense of protection the device provided them. When it was approved, I had multiple patients asking if they can be first or get the device early on in its release.”
Clinical trials for AngelMed overall involved about 950 patients in the U.S. Alerts sent to patients to seek medical treatment led to “significantly decreased detection to arrival time at a medical facility,” 51 minutes compared to 30.6 hours, according to an April paper on the clinical trial published by the National Center for Biotechnology Information.
The earlier a patient gets to an ER when heart attack occurs and receives treatment, the less damage is likely to occur to the heart muscle, improving the chances of survival and recovery.
While patients enrolled in the clinical trials trusted the device, there was a learning curve for physicians, Wohns said.
Physician trust “was something we dealt with” in the trial, he said. That phenomena “is not uncommon” with new medical technologies.
“For many people, it’s hard to fully grasp that they’re going to be treating somebody who has no symptoms but a monitor that’s telling them that they have something bad going on with their heart,” he said. “It’s disruptive because it does change how we think about things.
“It’s a different paradigm to think of somebody coming in because a monitor is going off that they can’t easily look at in a patient sometimes is feeling fine with a silent heart attack.”
Wohns cites a case at Spectrum Health during the clinical trial in which a patient with the implanted AngelMed device came to the ER after receiving an alert. The patient’s EKG in the emergency room “looked OK.”
Wohns downloaded the data, then took the patient to the cath lab. The person ended up having a 99-percent blockage in an artery.
“It’s seeing that once that makes you a believer,” Wohns said.