The Extravascular Implantable Cardioverter Defibrillator System is a “first-of-its-kind defibrillator with the lead placed under the breastbone, outside of the heart and veins,” Medtronic said in an Aug. 28 news release.
Of the 316 participants in the study, which was published Aug. 28 in The New England Journal of Medicine, 92.6 percent did not experience any device complications at the six-month mark.
Medtronic did not release a timeline for when it might seek FDA approval but said it’s continuing its trials as “the agency reviews the company’s EV ICD pre-market application.”
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