A new study undertaken by medical device firm St Jude Medical (SJM) has confirmed the positive benefits of the Nanostim leadless pacemaker for patients in need of a single-chamber ventricular pacemaker.
Having enrolled 526 patients at 56 centres across the US, Canada and Australia, the LEADLESS II investigational device exemption (IDE) study is claimed to be the largest published study conducted so far to evaluate leadless pacing technology.
Primary results from the study, which also demonstrated the pacemaker’s longer-term retrievability and its significant projected battery longevity, were published online in The New England Journal of Medicine and presented at the ESC Congress 2015 in the UK.
St Jude Medical chief medical officer Dr Mark Carlson said: "Leadless pacing is a new frontier for modern medicine, and a potential solution for physicians who want to retain the reliability of conventional pacing options but offer their patients a less invasive procedure.
"The Nanostim leadless pacemaker allows for a procedure without the need for a surgical pocket or the leads required by traditional pacemakers.
"Combined with prior data from the LEADLESS trial, the results of LEADLESS II demonstrate the Nanostim leadless pacemaker should be considered as a clinical alternative by physicians who want to provide patients a leadless pacing option that offers long-term longevity and device retrievability."
The trial reached both endpoints for primary effectiveness, including appropriate pacing and sensing, as well as safety that is freedom from serious adverse device effects.
During the 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%, 1.7%, and 1.3%, respectively, which is consistent with traditional pacemakers.
The Nanostim leadless pacemaker has been designed to be implanted with minimal surgery through the femoral vein, unlike traditional pacemakers, which are more invasive.
Implanted with the smallest available leadless technology delivery system comprising the catheter and an 18 F introducer, the pacemaker eliminates the surgical pocket and leads, which are the most vulnerable components of legacy pacemakers.
The self-contained device is approximately 1.5in-long and under 6mm in diameter, and is less than 10% the size of a conventional pacemaker. The device received the CE Mark in October 2013.
>Image: The Nanostim leadless pacemaker is less than 10% the size of a legacy pacemaker Photo: courtesy of Business Wire.