Study results for Nanostim leadless pacemaker published in New England Journal of Medicine-St Jude Medical

St. Jude Medical has announced primary results from the LEADLESS II study that confirm the positive benefits of the Nanostim leadless pacemaker for patients in need of a single-chamber ventricular pacemaker. The study also demonstrated the Nanostim leadless pacemaker’s longer-term retrievability and the device’s significant projected battery longevity. The LEADLESS II investigational device exemption (IDE) study is the largest published study to date to evaluate leadless pacing technology, having enrolled 526 patients at 56 centers across the United States, Canada and Australia. Results from the study have been published online in The New England Journal of Medicine and presented during a Hotline session at the ESC Congress 2015. After six months, data from LEADLESS II shows the trial met both endpoints for primary effectiveness (appropriate pacing and sensing) and safety (freedom from serious adverse device effects).

In addition, data from LEADLESS II also demonstrated Nanostim Leadless Pacemaker’s Retrievability, which is a core benefit of the Nanostim leadless pacemaker. Over the duration of the study, LEADLESS II demonstrated that retrieval of the implanted Nanostim leadless pacemaker was successful in 100 percent of patients requiring retrieval without any associated complications. Based on data from LEADLESS II, Nanostim leadless pacemaker’s battery could be projected to last an average of 15 years, and possibly projected as high as 21 years depending on pacing needs. The longevity of the Nanostim device has been estimated to be 9.8 years at 100 percent pacing. Within the LEADLESS II study, a total of 22 serious adverse device effects were observed over six months, including cardiac perforation, device dislodgement, and elevated pacing capture thresholds at rates of 1.3 percent, 1.7 percent, and 1.3 percent, respectively, which is consistent with traditional pacemakers.