St. Jude Medical Announces Results of Study of Nanostim Leadless Pacemaker
St. Paul, Minn.-based St. Jude Medical announced that a study of Nanostim leadless pacemaker, developed for patients in need of a single-chamber ventricular pacemaker, showed positive results.
The data, published in The New England Journal of Medicine, show the trial met both endpoints for primary effectiveness (appropriate pacing and sensing) and safety (freedom from serious adverse device effects).
The study of 526 patients also found that retrieval of the pacemaker when necessary was successful in 100 percent of patients without associated complications.
The company says the study observed 22 serious adverse device effects over six months, including cardiac perforation, device dislodgement and elevated pacing. Each effect occurred at a rate below 2 percent, the company says, which is consistent with traditional pacemakers. — Michael Cipriano