A clinical trial of the Guardian implantable heart attack monitor made by Angel Medical Systems failed to meet its efficacy endpoint, but suggested that the device could be used to help detect “silent” heart attacks.
Wilmington, Del.-based AngelMed won FDA clearance a year ago for the Guardian device for patients with prior acute coronary syndrome events including myocardial infarctions or unstable angina at high risk for further ACS events. Its 907-patient Alerts study randomized patients implanted with Guardian to either six months with the alert function active for the treatment group or six months without activation for the control arm; both groups had the alert function activated after the six-month randomized stage.
The primary efficacy endpoint, a confirmed occlusive event within 7 days, was not significantly reduced for the treatment arm at 3.8%, compared with 4.9% for the control arm. The primary safety endpoint was met a 96.7% rate of freedom from device-related complications, according to the study, published in the Journal of the American College of Cardiology and presented last month at the annual Cardiovascular Research Technologies conference in Washington, D.C., by principal investigator Dr. Michael Gibson.
However, the Guardian device cut detection-to-arrival-time from 30.6 hours to 51 minutes and an expanded analysis showed a higher predictive value and lower false positive rate for the treated cohort.
“Although the trial did not meet its pre-specified primary efficacy endpoint, results suggest that the device may be beneficial among high-risk subjects in potentially identifying asymptomatic events,” wrote the study’s authors, all of whom received research grants from AngelMed, including one who owns a stake in the company.
“As Dr. Gibson discussed in his presentation, the Guardian has shown that it can get patients to the ER even if they do not have symptoms of ACS events, including silent heart attacks. This is a first-ever capability for any product and allows the Guardian to fill an unmet medical need by providing more effective diagnosis of a life-threatening condition compared to relying on patient symptoms alone,” AngelMed CEO David Fischell said in prepared remarks.
Last last month the company emerged from Chapter 11 bankruptcy protection with a $10 million Series A round.
