Implantable monitor to warn of ACS events garners FDA approval
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Angel Medical Systems announced its second-generation implantable cardiac detection monitor, which can warn patients about ACS events, including silent MI, received approval from the FDA.
The second-generation system (AngelMed Guardian) has improved battery life and ease-of-use adaptations compared with the first generation, according to a press release from the company.
The device is implanted subcutaneously during an outpatient procedure and monitors the heart for electrical changes that could portend an ACS event, according to the release.
“Patients who have had a prior ACS event often remain at high risk of a recurrent event. Even those patients who are on alert for another potential cardiac event may delay seeking treatment,” C. Michael Gibson, MD, MS, consultant at Boston Clinical Research Institute, said in the release. “The AngelMed Guardian system has demonstrated the ability to identify the earliest signs of an ACS event, including heart attacks, more effectively than patients’ symptoms alone, and in patients who do not experience symptoms at all.”
The technology could experience prompt uptake in clinical practice, David Wohns, MD, cardiologist at Spectrum Health in Grand Rapids, Michigan, told Healio.
“As the first-ever diagnostic tool for the detection of an ACS event and one that leads to earlier treatment and the detection of silent heart attacks, this technology is a game changer for these patients,” he said. “As with any new disruptive technology, there is a postapproval period of continued learning and experience by clinicians. This device meets a true unmet need in these high-risk patients and I believe we will see continued uptake over time in the care of patients with coronary artery disease. One of the most striking findings from the ALERTS trial was the impact on patients’ perceived quality of life. Our patients reported comfort and reassurance knowing their heart was being monitored continuously for potential recurrent cardiac events and that they had an early warning system to alert them.”
Further research could bring more advancements in this technology, Wohns said in an interview.
“Postapproval clinical experience and surveillance will undoubtedly add to our understanding of which patients benefit most from this device,” he said. “In addition, as this technology evolves, imagine a future where a 911 ‘call’ is initiated by the device or one in which this technology is embedded in other devices like automated implantable cardioverter defibrillators or pacemakers. This is the early stage of implantable technology for monitoring a health condition and I think we will continue to see this space grow and evolve.”
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