St. Jude Medical’s Nanostim leadless pacer meets 6-month safety, efficacy goals

The Nanostim implantable pacemaker made by St. Jude Medical (NYSE:STJ) met its 6-month safety and efficacy endpoints, according to data presented over the weekend at the annual meeting of the European Society of Cardiology in London and published in the New England Journal of Medicine. The Leadless II study enrolled 526 patients in the primary cohort, with 300 completing the 6-month protocol in June. The entire group was followed for a mean 6.9 months, showing successful implantation of the Nanostim device in 504 (95.8%) of subjects, according to the NEJM paper. In some 29.8% of the cases, the Nanostim device needed repositioning; in 22 cases (4.4%) the device needed repositioning more than twice. “In summary, the Nanostim leadless cardiac pacemaker met pre-specified pacing and sensing requirements in 90% of the patients in whom an implantation was attempted and in 93.4% of the patients in whom the implantation was successful,” the researchers wrote, noting that the study design was limited in not allowing a direct comparison to conventional pacers. “Currently, the leadless cardiac pacemaker can serve as only a single-chamber ventricular pacemaker, which accounts for a minority of implanted pacemakers in the United States. The leadless cardiac pacemaker also cannot provide electrographic data. Refinements in device-to-device communication, atrial affixation, and device diagnostics would be necessary for this device to fully replace conventional dual-chamb...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Clinical Trials Cardiac Rhythm Management European Society of Cardiology (ESC) Nanostim Inc. St. Jude Medical Source Type: news