Medtronic (NYSE:MDT) today released 1-year results from a study of patients who experienced a cryptogenic stroke, claiming that its Reveal Linq insertable cardiac monitor was able to detect atrial fibrillation at a greater rate than previously reported in a 2014 clinical trial.
Results from the real-world study were presented at the 68th American Academy of Neurology’s annual meeting in Vancouver, Canada.
The Reveal Linq device is designed to be implanted beneath the skin on the upper left side of the chest and is indicated for monitoring patients experiencing dizziness, palpitation, fainting or syncope, chest pain and cardiac arrhythmias. Billed as the world’s smallest cardiac monitor, it’s about ⅓ the size of a triple-A battery, Medtronic said, and is designed to work for 3 years using the company’s CareLink network.
A total of 1,247 patients were evaluated in the trial, which looked to examine the incidence and duration of AF episodes in a large, real-world population of crypotgenic stroke patients with an ICM. At 1 year, 1,737 AF episodes were detected in 192 patients, returning a 16.3% rate of detection – a 32% relative increase compared to the rate observed in the earlier Crystal AF trial in 2014.
“In clinical practice, we continue to see increased AF detection rates using the insertable cardiac monitor compared to the rigorously-controlled Crystal AF study. What’s most significant, however, is that the vast majority of patients had their first AF episode beyond the range of 30-day conventional monitoring, reinforcing the need to reevaluate the standard AF monitoring guidelines for cryptogenic stroke patients,” co-author Dr. John Rogers of La Jolla, Calif.’s Scripps Clinic said in a prepared release
Though the current recommended guidelines for AF detection are 30-days of monitoring within 6 months of a cryptogenic stroke, the study found that 72% of patients diagnosed with AF would have been undiagnosed if cardiac monitoring had been limited to 30 days.
Earlier this month, Medtronic said it won FDA premarket approval for its Micra transcatheter pacing system, which it claims is the world’s smallest pacemaker.
The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. The Micra device has an estimated 12-year battery life and is approved as safe for full-body MRI scans, the company said.
Micra is cleared with indications for patients with a heart arrhythmia called atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome, according to an FDA release.