Medtronic (NYSE:MDT) today showcased data from a real-world study of cryptogenic stroke patients implanted with its Reveal Linq cardiac monitor, saying the device detected atrial fibrillation at an even greater rate than found in a prior study.
The observational study tracked 1,247 patients who suffered strokes for unknown reasons for signs of atrial fibrillation using Reveal Linq, Medtronic said. After a median of 182 days, AF was detected in 147 patients (12.2%), "which was nominally 37% higher than the rate observed in Crystal AF at the same time point," the company said.
"Unlike a randomized study, an observational study provides a practical way to study real-world clinical practice. What’s most exciting is that the detection of AF in real clinical practice exceeded that observed in the rigorously-controlled Crystal AF study, allowing physicians to intervene even more with stroke preventive therapies," co-author Dr. Mark Richards of Toledo’s ProMedica Physicians Cardiology said in a statement. "This suggests that AF may go undetected at an even greater rate and reinforces the benefits of long-term rhythm monitoring in cryptogenic stroke patients."
Results from the observational study are slated to be presented at the American Stroke Assn.’s International Stroke Conference in Nashville this week, according to a press release. Results from the Crystal AF study were published in The New England Journal of Medicine last June.
Medtronic also said a new analysis of data from Crystal AF shows that the insertable cardiac monitors are cost-effective in detecting AF in cryptogenic stroke patients. Results presented at the International Stroke Conference showed that the "incremental cost-effectiveness ratio" from its Reveal XT device was "well within the cost effectiveness range that the United Kingdom’s National Institute of Clinical Excellence considers acceptable," compared with the standard of care.
"These results show that continuous cardiac monitoring with an ICM is a cost-effective tool," Dr. Klaus Witte of the University of Leeds said in prepared remarks. "Detecting AF in cryptogenic stroke patients enables physicians to change their medical therapy so we can reduce their risk of having a second stroke."
Reveal Linq last year won CE Mark approval in the European Union and 510(k) clearance from the FDA.